What Is Pharmacognosy?

Biopharmaceutical (pharmacognosy) refers to the main research object of crude drugs, the name of the crude drug, source (base source), production (cultivation), collection (collection, processing, processing), identification (authentication and quality evaluation), chemical composition , Medical use, tissue culture, resource development and utilization, and new drug creation. In other words, biopharmaceuticals is a discipline that uses natural medicine, botany, zoology, chemistry, pharmacology, medicine, and molecular biology to study the application of natural medicine.

Chinese name: Pharmacy
Foreign name: pharmacognosy

Research object: Based on crude drugs
main mission: The types and sources of graduate medicine

Department of Biopharmaceutical Medicine

Crude drug refers to natural, unprocessed or simple processed plant, animal and mineral medicines, which means "raw drug".

In a broad sense, crude drugs should refer to all natural raw materials, including traditional Chinese medicine, folk herbs, ethnic medicines, and raw materials that can be used to extract chemical drugs. In short, crude drugs are natural herbs.

In our country, crude drugs are closely related to Chinese medicinal materials (including herbs and ethnic medicines). The so-called Chinese medicines usually refer to medicines processed, processed and used under the guidance of basic theories of Chinese medicine, which are part of natural medicines. Medicinal herbs generally refer to the natural medicines and their simple processed products that are widely spread to the people, mostly used by traditional Chinese medicine, have a strong geographical area, and have a narrow area of use. They are generally difficult to obtain at hospitals and pharmacies at all levels. Herbs and Chinese medicines are collectively referred to as Chinese herbs in China and are also part of the Chinese medical system. Ethnic medicines (ethnomedicines) refer to natural medicines used by various ethnic minorities to prevent and treat diseases. In China, it is also part of the traditional Chinese medicine system, but it is limited to use in certain areas (minority residential areas) and has its own unique drug habits, such as Tibetan medicine, Mongolian medicine, and Uyghur medicine. Ethnic medicine belongs to the category of ethno-medicine.

With the continuous exploration, research and popularization of herbal medicines and ethnic medicines, some herbal medicines and ethnic medicines with good curative effects and clear quality standards will be widely used and distributed throughout the country like traditional Chinese medicine. Raw medicines are closely related to Chinese medicinal materials, herbs, and ethnic medicines, and their meanings are sometimes difficult to distinguish clearly. Generally, they are mainly guided by the theory of traditional Chinese medicine as the principle of medication. If so, they are called Chinese medicinal materials, otherwise they can be called Crude medicine.

The main tasks of pharmacy

Varieties and sources of graduate medicine

At present, the source of crude drugs is relatively complex, fake and inferior products often appear, the history of medications and medication habits in different places are different, and the names of medicines are also different. The same name foreign matter, the same name with different names sometimes appear, such as clearing heat and detoxifying, cooling blood The medicinal parts for rhizome and petiole are the base of rhizome and petiole. At present, the medicinal materials with the exact effect of medicinal name are Mianma Guanzhong (Dryopteris crassirhizoma Nakai), Osmunda japonicaThunb., Osmanda japonicaThunb. Cycad fern Brainea insignis (Hook, f.) Sm.), Viburnum fern (Zucchini fern Metteuccia m shed a teris (L) Todard), and Emei fern (Lunathyrium acrostichoides (sw.) Ching). According to surveys, there were 58 species of ferns in the country that had been used as medicine for many people, most of which were fakes. In addition, there are many varieties from various sources in crude drugs, such as rhubarb with the functions of clearing heat and intestines, cooling blood and detoxifying, and removing stasis and passing through menstruation. The medicinal parts are rhizomes and roots. "Chinese Pharmacopoeia" contains three kinds of base sources, namely Rhubarb Rhubarb Lumum palmatum L, Rhum tanguticumm Maxim.ex Balf. Licorice roots and spleen replenishing qi, clearing heat and detoxifying, expectorant and cough, slowing pain and analgesic, reconcile the efficacy of various medicines. The medicinal parts are roots and rhizomes. The Chinese Pharmacopoeia contains three basic sources of licorice, namely the legume licorice Glycyr-rhiza uralensis Fisch., Glycyrrhiza infiata Bat. And Glycyrrhiza glabra L. The above situation is more common in crude drugs. A biological species has evolved over a long period of time, and individuals of the same species have the same genetic traits and chemical characteristics. In the current assessment of the quality of crude drugs, the identification of a species, that is, ensuring its source is the most important part. In view of the complexity of the source of crude drugs, accurately identifying the species and ensuring the authenticity of the source is one of the first tasks of biopharmaceuticals.

Active ingredients and identification of graduate medicines to ensure good quality

The reason why crude medicine can prevent and cure diseases is because it contains effective ingredients that can prevent and cure diseases. Therefore, in order to measure the quality of crude drugs, in addition to identifying the species, it is necessary to determine the type, content, stability and identification method of its active ingredients. This requires that the biopharmaceuticals must change the law of the active ingredients of the graduate medicine and the necessary control measures to ensure that the quality of the crude medicine is excellent. There are many factors that affect the quality of crude drugs. In addition to species, improper cultivation techniques, unsuitable cultivation areas and habitats, and irregularities in harvesting, processing, packaging, transportation, storage, processing, preparation, and preparation can all make crude drugs. Changes in active ingredients. Because the quality of crude drugs in each link of production and distribution is a dynamic change process, therefore, various factors affecting the quality of crude drugs are studied, the dynamic changes of the quality of crude drugs are explored, and then the quality is comprehensively monitored, regulated and identified. To ensure that the quality of crude drugs is good, safe, uniform, stable and controllable. On this basis, the quality evaluation methods and standards for the quality of crude drugs were established.

Graduate Medicine Resources and Their Sustainable Development and Utilization

Biomedical resources include plant resources, animal resources, and mineral resources. The former two are biological resources and belong to renewable resources, while the latter are non-biological resources and belong to non-renewable resources. Biopharmaceutical resources are limited, disintegrable, and regional. Their reserves are limited. As people's demand is increasing, the means of development and utilization are not scientific and reasonable, and the lack of necessary protection and scientific management has led to many biopharmaceuticals. Resources are rapidly decreasing, such as ephedra, licorice, pangolin, toad, northeast forest frog, etc. Some species are even endangered, and good germplasm is gradually disappearing, such as Cordyceps sinensis, Dendrobium Huoshanense, High-nosed Antelope, and Black Bear. Every species on earth has survived a long history and experienced natural evolution. Its excellent germplasm is the basis of the quality of crude drugs. For example, when the number of individuals in a natural population is reduced to a certain number, its excellent germplasm characteristics are at risk of loss, leading to the disintegration of certain biological species. Once a species becomes extinct and disintegrates, it will disappear forever on the earth and cannot be recovered.

The sustainable development of resources is a basic national policy of our country. The so-called sustainable development is the development that can meet the contemporary demand for resources without endangering the ability of future generations to meet their needs; continuously improving the quality of life and environmental carrying capacity of the population, and meeting the needs of contemporary people without compromising the ability of future generations to meet their needs Development; to meet the needs of the population in one region or country without compromising the ability of the population in other regions or countries to meet their needs. Sustainable development is the foundation of sustainable use. To this end, biopharmaceuticals also need the status and development of graduate drug resources, the protection and production of endangered and shortage of crude drugs, and the search for and expansion of new drug sources, so that their energy sources can continuously and high-quality meet the needs of the broad masses of people and pharmaceutical companies. And demand for APIs.

In short, the purpose of teaching biopharmaceuticals is to train students to have the skills to identify and test the quality of biopharmaceuticals, evaluate the quality of biopharmaceuticals, and formulate the quality standards of biopharmaceuticals, and also have the relevant knowledge and skills of applying biopharmaceuticals. Initial ability to develop crude drug resources. Through study and practice, it is competent for research, inspection, sales, management, production and quality evaluation of crude drugs.

Biopharmaceutical learning methods

Biopharmaceuticals is an important professional course in traditional Chinese medicine. It is closely related to medicinal botany, natural medicinal chemistry, traditional Chinese medicine pharmacology, and related natural medicine and traditional Chinese medicine courses. Since most medicines come from plants, medicinal botany is the most important basic course of biomedicine.

Studying biopharmaceuticals should be more related to reality. In addition to learning basic theories and knowledge, we must also attach great importance to experimental operations and practical teaching. They are often identified in the field or in the medicinal material warehouse, herbarium (room) and laboratory, and more observation and comparison. Compare the morphological characteristics of various types of medicinal plants and crude drug specimens, find their similarities and differences, and then compare the content of teaching materials and lectures or other reference books to deepen the impression and understanding of the relevant content of the book. Don't memorize rote memorization. Usually, you need to observe, compare, experiment, and practice. The theory is closely related to practice, so that you can learn to live, learn well, and apply what you learn.

Origin and development of pharmacy

The origin and history of Chinese herbal medicine

The source of human drug knowledge goes back to ancient times. While searching for food, people have repeatedly tried and found many plants with physiological effects that can be used to prevent and treat diseases. Therefore, there is a saying that "medical food is homologous". Ancient books record that the Shennong family (circa 2700 BC) tasted Baicao to treat diseases, and encountered 70 poisons in one day, indicating that our ancestors had long and extensive medical practice processes, and their drug knowledge gradually grew. However, the writing was not developed in the Archaic period, and this knowledge can only be dictated by the teacher. Later, with the text, it was gradually recorded, and medical books appeared. These books play a role in summing up the previous experience, and facilitate the spread and promotion. Since herbs are the majority in medicines, the books describing the medicines are called "Materia Medica". According to research, during the Qin and Han dynasties, herbal medicine had become more popular, but these herbal medicines were dead and could not be examined. The earliest known Materia Medica work is the "Shen Nong's Materia Medica". The author is unknown. According to the place names recorded in it, it may be that the Eastern Han medical doctors Zhang Zhongjing, Hua Ye, and others revised the previous works.

The three volumes of the "Shen Nong's Materia Medica" contain 365 kinds of medicines, including animals, plants, and minerals. They are divided into three categories: "One hundred and twenty kinds of medicines are kings, and the Lord's life is in heaven. Poisonous, long-serving clothes will not hurt people, if you want to lighten your health, do not grow old and prolonged, this is the classic scripture; 120 kinds of traditional Chinese medicine as the minister, the main nature is to respond to people, non-toxic and toxic, consider appropriate, want to curb For those who have tonify the deficiency, this classic scripture; the 125 classics are used as envoys. They treat the disease according to the situation, it is poisonous and should not be served for a long time. ". Each medicine download has sexual flavor, function, and indications, and there are other examples to briefly describe the basic theory of medication. If there are toxic and non-toxic, four flavors and five flavors, compatibility prescriptions, medication methods and pills, powders, ointments, alcohol and other dosage forms, it can be said that "Shen Nong's Materia Medica" is a summary of China's drug knowledge before the Han Dynasty and laid the foundation for future drug development.

During the Daoguang reign of the Qing Dynasty, Wu Qi's two books on plants were published, "The Plant Names and Pictures", and the "Plant Names and Pictures". The former recorded 1,714 kinds of drugs, and the latter described 838 kinds of plants. For each The description of the plant's shape, sex, use, and place of origin is quite detailed, with accurate illustrations. It focuses on the medicinal value of the plant and the study of the foreign body with the same name. Therefore, although it is not a pharmacological monograph, it also has important reference value.

The development of modern pharmacy

Biopharmaceuticals is a science of natural medicine that gradually accumulates and develops with the needs of production development and the progress of scientific research in the process of humans fighting diseases. Historically, the development of biopharmaceuticals can be roughly divided into three periods, namely the traditional herbal medicine (or pharmacology) period, the modern commercial biopharmaceutical period and the modern new period of biopharmaceuticals.

The ancient Chinese herbal medicine appeared more than 2,000 years ago, and until the middle of the nineteenth century, pharmacy became an independent discipline, and all countries in the world were in the traditional period of herbal medicine. At that time, knowledge of medicines (raw medicines) was mainly accumulated through sensory and practical experience. The contents of ancient Chinese herbal medicine books were mainly used to record medical effects, as well as the names, origins, forms, and characteristics of sensory identification of crude drugs and medicinal plants and animals. Because of different regions and differences in experience, it is difficult to agree on the understanding of drugs, and because of the undeveloped science at that time, the understanding of drugs is unavoidably superficial or subjective.

The continuous clarification of the active ingredients of crude drugs and the rapid development of their analytical methods have ushered in a new era of modern biopharmaceuticals, and promoted the scientific discussion of various factors affecting the quality of crude drugs. For example, research on seed selection, grafting, hybridization, environmental conditions and cultivation techniques, and control of diseases and insect pests on medicinal plants (such as mint, digitalis, cinchona, etc.) with clear active ingredients, large economic value, and large cultivation, In order to improve the yield and quality; research on the harvest time, processing methods and storage conditions of crude drugs, and strive to improve and maintain the excellent quality of crude drugs.

Artificial methods cause mutations in medicinal plant genetic factors and the formation of polyploid plants. Tracer atoms are used to explore the formation of active ingredients in plants and their influencing factors. Cell and tissue culture methods are used to produce effective substances in medicinal plants. Has made progress. Due to the large accumulation of plant chemical composition knowledge, scientific discussions have been carried out on the chemical composition of various types of plants and their kinships, and plant chemistry taxonomy (Plant Chemotaxonomy) has begun to form. The development of this science has taxonomic significance And will promote the development of new crude drug resources.

Classification of student medicine

Biopharmaceutical classification

First, the crude drugs are divided into plant drugs, animal drugs and mineral drugs, and the plant drugs are further divided into roots, rhizomes, skins, stems and woods, leaves, flowers, fruits, seeds and All grasses and so on. This classification method is convenient for studying and studying the shape and internal structure of graduate medicine, grasping the appearance and microscopic characteristics of various types of crude drugs and their identification methods; it is convenient to compare the similarities and differences in the appearance and microscopic characteristics of different kinds of crude drugs; Improve the experience of traditional medicinal material identification.

Biopharmaceutical classification by chemical composition

They are classified according to the type of active ingredient or main ingredient contained in the crude drug. Such as glycoside-containing crude drugs, alkaloid-containing crude drugs, volatile oil-containing crude drugs and so on. This classification method is convenient for studying and analyzing the active ingredients and physicochemical properties of graduate medicines; it is beneficial to study the relationship between active ingredients and curative effects, and the relationship between crude drugs with the same ingredients and their families.

Taxonomy of natural systems

According to the taxonomic position and phylogeny of the original plant (animal) of the crude drug, it is sorted by phyla, class, order, family, genus and species. This taxonomy is convenient for studying and studying the common features of the same class of crude drugs in terms of morphology, properties, tissue structure, chemical composition and efficacy, etc., and comparing their specificities to reveal their regularity; it is helpful to find similar components and efficacy Plant (animal) to expand the resources of crude drugs. This textbook is classified in this way.

Biopharmaceutical classification by pharmacological action or traditional Chinese medicine efficacy

Classified according to the pharmacological effects of traditional Chinese medicine or the efficacy of traditional Chinese medicine. For example, according to modern pharmacological effects, they can be divided into: crude drugs acting on the nervous system, crude drugs acting on the circulatory system, etc .; This taxonomy is convenient for learning and the role and efficacy of graduate medicine, which is conducive to clinical integration, and can also be combined with the active ingredients it contains.

Other classifications of pharmacy

In history, the earliest existing Chinese herbal medicine "Shen Nong's Materia Medica" is divided into three categories: upper, middle and lower according to the toxicity of the drug and the purpose of use. , Fruits and vegetables, rice, famous unused, etc. 6 categories, each category is divided into three grades; the Compendium of Materia Medica classifies medicines into water, fire, soil, stone grass, grain, vegetables, fruits, wood, and utensils 16 insects, scales, scales, birds, beasts, humans, etc., and the medicines of each department are divided into 60 categories according to their ecology and properties, such as grass grass, fragrant grass, wet grass, poisonous grass, creeping grass, water grass , Stone grass, moss, weeds, etc., and arrange plants with similar relationships.

In modern times, books such as the Pharmacopoeia of the People's Republic of China, the Dictionary of Traditional Chinese Medicine, The Book of Traditional Chinese Medicine, and the Book of Traditional Chinese Medicine are all arranged in the form of a dictionary in the stroke order of Chinese names. This is the simplest type of layout for easy reference. However, there is a lack of interrelationship among various crude drugs, and this method is not used in general textbooks. The above various classification methods can be selected according to different purposes and requirements in practical applications. ^[1]

Outline of records of student medicine

The biopharmaceuticals contained in the monographs of biopharmaceutical textbooks are described in a certain order. Among them, the more important narratives are more detailed, and the less important ones are simpler. The outline of the records are described as follows:

1. Name includes Chinese name, Latin crude drug name, English name and Japanese name.

Source or base source

Includes biological and geographic sources. The biological source includes the family name of the original plant (animal), the plant (animal), the Latin scientific name, and the medicinal part. The names of most crude drugs are consistent with the names of the original plants (animals), and some of them are different from the original plant names. For example, the original plant name of Daqingye is Isatis indigotica and the original plant name of honeysuckle is Lonicera. Geographical source refers to the main place of production of crude drugs. For cultivated plants, it refers to the main cultivated area. For wild plants, it refers to the main harvest area. Most wild plants are distributed in a wide area, but the harvest area is relatively narrow. .

3. Plant (moving) matter form

Describe the main appearance characteristics and growth habits of the original plant (animal). It is easy to collect in the field, and also helps to understand the characteristics of crude drugs, especially the whole herb. For a detailed description of plant morphology, you should check the "Chinese Medicinal Plant History", "Chinese Plant History", "Chinese Medicine History" and the flora and history of Chinese medicine compiled by various provinces and cities.

4. Cultivation of medicinal plants (animals)

Understanding the cultivation of medicinal plants and the raising of medicinal animals is of great significance in guiding the production of crude drugs, improving yield and quality, etc. This is an important measure to provide and ensure clinical use of medicines. The textbook introduces the cultivation of some important medicinal plants.

5. Mining

Briefly summarize the main points and points of attention in the collection, processing, drying, storage and processing of crude drugs. The raw materials that need special collection are introduced.

6. The place of origin introduces its main producing areas to crude drugs with special economic benefits.

7. Traits

Describe the external shape, color, size, texture, cross-section characteristics, and qi and taste characteristics of crude drugs. Using sensory perception or using a magnifying lens to correctly grasp and familiarize the characteristics of crude drugs is of great significance for identifying and identifying crude drugs.

8. Microscopic features

Record the structure and powder characteristics of the crude drug that can be seen under the microscope, or the results of microchemical reactions. Familiar with the microscopic characteristics of crude drugs is of special significance for identifying crude drugs with similar shapes and fragments or powders. This is one of the means for authenticating crude drugs. In the teaching of biopharmaceuticals, microscopic observation of crude drugs, description of microscopic features and drawing techniques are important basic skills.

9. Chemical composition

Describe the names, categories, and structures and contents of known chemical or active ingredients, and describe their biosynthesis, distribution, accumulation dynamics in plants, and their relationships with crude drug cultivation, harvesting, and storage. The chemical composition of the crude drug, especially the active ingredient or active ingredient, is the material basis for the curative effect of the crude drug, and is also the basis for the physicochemical identification and quality evaluation of the crude drug.

10. Physical and chemical identification

Record the qualitative and quantitative determination of the chemical components contained by physical or chemical methods. Thin-layer chromatography, gas chromatography, and high-performance liquid chromatography are now more commonly used. Physical and chemical identification is one of the important methods for the quality evaluation of crude drugs.

11. Pharmacological effects

Describe the results of modern pharmacological experiments of crude drugs and their chemical constituents. It is conducive to linking its functions and indications, and to understand the principles of its clinical efficacy.

12. Efficacy

Including sexual taste, guijing, function, indications, usage and dosage. Sexual taste, meridian and function are the Chinese medicine's understanding of the medicinal properties and pharmacological effects of Chinese medicine. Indication refers to the disease or medical value of crude medicine. Regarding the function of crude drugs, we must record not only the experience of traditional Chinese medicine, but also the content of modern medicine.

13. Notes

Describe other contents related to the crude drug, such as crude drugs of the same kind, foreign substances of the same name, adulterants, fakes, etc., or crude drugs and their chemical components of the same different medicinal parts, or resource plants containing the same chemical components, etc. . ^[2]

Latin name of student medicine

The Latin name of the crude drug is an internationally used name, which can be understood by scholars from all over the world, so it has international significance and facilitates international exchanges and cooperative research.

The Latin name of the crude drug usually consists of two parts. The first part is the name of the medicinal part. It is indicated by the first cell. Common ones are: Radix Root, Rhizoma Rhizoma, Caulis Stem, Lignum Wood, Ramulus Bark, Cortex Bark, and Folium Leaf. , Flower Flos, Pollen Pollen, Fruit Fructus, Peel Pericarpium, Seed Semen, Whole Grass Herba, Resina Resin, Secretion Veneneum, etc. The second part has multiple forms: the genus name (second grid) of the original plant (animal), such as: Radix Scutellariae (original plant Scutellaria baicalensis), Calculus Bovis (original animal Bostaurus domesticus); The species name (second cell) of the animal), such as Belladonna Herba Belladonnae (original plant Atropa belladonna); (3) The genus name and species name (second cell) of the original plant (animal) animal are used to distinguish the source of other species Crude drugs, such as: Artemisia Herba Artemisiae, Herba Artemisiae Scoporiae, Cornu Saigae Tataricae, antelope horns (second box) and other additional words to describe specific properties or states, such as: Radix Rehmanniae Preparata, deer antler Cornu Cervi Pantotrichum.

Some Latin medicines do not have the name of the medicinal part in the Latin name, and directly use the genera or species name of the original plant (animal). For example: some fungi and algae crude drugs, such as: seaweed Sargassum (genus name), Poria Poria (genus name); crude drugs made from intact animals, such as: Mylabras (genus name), toad Gecko (species name); (3) The dry secretions and juices of animals and plants, and other unorganized crude drugs, such as: Musk Moschus (genus name) and Aloe Aloe (genus name). Some Latin names use native or common names of origin, such as: Opium Opium, Galla Galla.

The Latin names of mineral crude drugs are generally Latin names such as cinnabar Cinnabaris and realgar Realgar. At present, in some countries' pharmacopoeia, the names of the medicinal parts of the Latin names of the crude drugs are placed after the genus and species names. In this way, when sorting according to the Latin names of the crude drugs, different crude drugs of the same crude drug source can be arranged together for easy comparison. Example: Belladonnae

Folium, Belladonnae Radix.

Sometimes the name of the medicinal part is omitted, and only the genus name (the first box) is used. Such as: Digitalis Digitalis, Mint Leaf Mentha, Coptis Coptis.

Comparison of quality standards for students' medicines

Overview of Chinese and Japanese Pharmacopoeia Loading Standards

In traditional Chinese medicine, botanicals, as the main drugs used clinically, have long been used in formulas such as soups and powders, forming a unique system. Botanical medicines have been included in various pharmacological (herbal) books of various dynasties. The pharmacopoeia of the Tang Dynasty edited and promulgated by the government, most of which are in pharmacopoeia, are new botanicals. It can be said that pharmacopoeia contains plants. The beginning of the medicine. Traditional Chinese medicine and its technology for applying botanical drugs have also been widely spread in Japan, North Korea, Vietnam and other countries, with far-reaching effects. At present, the pharmacopoeia of these countries contain a lot of botanical medicines, and set certain standards for their safety and quality. Taking representative Japan as an example, the 14th revised edition of the Japan Pharmacopoeia (JP) (including the supplemental version and the specifications of the external crude drug) contained a total of 249 crude drugs (including powder). According to statistics, Motohara and There are 83 varieties of medicinal parts consistent with the 2000 edition of the "Pharmacopoeia of the People's Republic of China" (CP).

Plant crude drugs are included in CP as a Chinese herbal medicine. In terms of identification, CP used to develop color and test-tube reactions with poor specificity, but now it has turned to TLC-based identification methods. In 2005, CP added 662 specific TLC identifications. In terms of inspection items, items such as impurities, moisture, ash, and acid-insoluble ash were generally added to ensure the purity of Chinese medicinal materials. There were 34 new impurities inspections, 178 moisture inspections, and 135 ash species. There are 130 varieties of insoluble ash. In terms of content determination, CP has been in use since 1990. It uses modern instrument detection methods such as high-performance liquid chromatography (HPLC), gas chromatography (GC), and thin-layer scanning (TLCS) to determine content. Of the 551 varieties of medicinal materials and decoction pieces, 281 have established content determination methods, of which 217 are analyzed by HPLC and other instruments, accounting for 77% of the total.

Japan formulated the pharmacopoeia standards for crude drugs earlier. The first edition of the Pharmacopoeia (1886) published during the Meiji period set administrative specifications for raw medicinal materials and introduced the universality of medicinal standards. In the subsequent revisions, new crude drugs will be added, and the recorded content of the received products will be modified according to technological progress and actual needs. JP established TLC and other methods earlier than CP in identification. Depending on the medicinal materials, UV spectroscopy (UV) and microscopy were also used. Comprehensive standards have also been established in terms of purity inspections, but the standards for determining the content of medicinal materials are not as good as CP, and the limit inspections for heavy metals, toxic elements, and pesticide residues are also behind the European and American Pharmacopoeia.

Student drug quality standards

Biopharmaceutical name and naming basis

The names of crude drugs include Chinese names, Chinese pinyin names, and Latin names. The naming should be clear, short, and scientific, without misunderstanding and confusion. The name should not be duplicated with the existing drug name.

Biopharmaceutical sources

The content includes the family name of the original plant (movable), the Chinese name of the plant (movable), the Latin scientific name, the medicinal part, the harvest season and the processing of the place of origin. Mineral medicine includes the type, family, ore name or rock name of the mineral, the main ingredients and the processing of the place of origin.

The original plant (movable) must be identified by the relevant unit to determine the family name, Chinese name and Latin scientific name of the original plant (movable), mineral Chinese name and Latin name. The medicinal part refers to a part or all of the medicinal substance after the plant (animal, mineral) is processed in the place of origin. Harvesting season and origin processing refers to the best harvesting season and origin processing method to ensure the quality of medicinal materials.

Pharmacological traits

Refers to the description of the shape, color, surface characteristics, texture, section, and odor of the crude drug. In addition to the description of the fresh product that must be used fresh, it is generally based on the complete dry crude drug. The fragile crude drug must also describe the broken part. . The description should capture the main features, the text should be concise, the terms should be standardized, and the description should be accurate. For the description of the characteristics of crude drugs, please refer to the relevant content in Chapter 2. The writing format of the trait characteristics is based on similar medicinal materials in the current Pharmacopoeia.

Biopharmaceutical identification

Including microscopic identification, physical and chemical identification, chromatographic or spectral identification and other methods of identification. The selection method requires exclusive and sensitive.

Microscopic identification

It is one of the important means for identification of crude drugs, including tissue section, powder or surface preparation, microchemical reaction.

2. Physical and chemical identification

Including color reaction, precipitation reaction, fluorescence reaction, etc., they are identification reactions of functional groups. Any component with the same functional group may be positive, so the specificity is not strong. Generally, it is not suitable as the final identification item in the quality standard. .

3. Chromatographic identification

It uses thin layer chromatography (TLC), gas chromatography (GC) or high performance liquid chromatography (HPLC) to identify the authenticity of crude drugs. For specific methods, refer to the relevant content in Chapter 3. Chromatographic identification should be set with reference substance or reference material control. The TLC method can accommodate multiple samples and multiple information (spots, color, Rf value, etc.) on a chromatography plate. As long as some characteristic spots (even unknown components) are reproducible, it can be used as a basis for confirmation. At the same time, TLC does not require special instruments and is easy to operate. In addition, in recent years, the application of high-efficiency adsorbents, commercial prefabricated plates, and camera devices has greatly improved the separation effect, detection sensitivity, accuracy, and reproducibility. TLC method has become the most widely used physicochemical identification method of biopharmaceuticals. GC method is suitable for the identification of medicinal materials containing volatile components. The binding content is generally determined. HPLC method is rarely used for identification. If the HPLC method or other methods cannot be used for content determination, it can be used for identification at the same time.

4. Spectral identification

In the identification of crude drugs, since the extracts of most medicinal materials may have the maximum absorption at about 270 to 280 nm, they cannot constitute the distinguishing characteristics of a certain medicinal material, or the characteristics are not strong. So in general, the spectrum is not used directly for identification. For example, in specific cases, based on a comparative study with similar or adulterated products, which can constitute a distinguishing feature, it can also be applied.

5. Fingerprint

The fingerprint of the crude drug refers to the spectrum of the common peak that can indicate the characteristics of the crude drug after proper processing of the crude drug by a certain analysis method. The purpose of establishing fingerprints of crude drugs is to fully reflect the types and relative contents of the internal chemical components contained in the crude drugs, and then reflect the overall quality of the crude drugs. Fingerprint is also an internationally recognized effective method for controlling the quality of natural products.

The biometric fingerprint must be systematic, characteristic, and reproducible.

Systematic means that the chemical components reflected in the fingerprint should include the main components in the effective component group, or all of the index components. If the active ingredient of rhubarb is anthraquinone, its fingerprint spectrum should reflect as much as possible of anthraquinone.

Characteristic means that the chemical composition information (specifically expressed as retention time or displacement value) reflected in the fingerprint is highly selective, and the comprehensive result of these information can distinguish the authenticity and quality of traditional Chinese medicine.

Reproducibility means that under the specified methods and conditions, the errors of fingerprints established by different operators and different laboratories should be within the allowable range.

The research and formulation of fingerprints of crude drugs have their specific content and technical requirements. Briefly described as follows:

(1) The name and Chinese pinyin are formulated according to the principle of naming Chinese medicine.

(2) The source includes the original plant, animal family name, Chinese name, and Latin name.

(3) The preparation of the test product should be based on the physical and chemical properties of the chemical components contained in the crude drug and the needs of the detection method. A suitable method should be selected for the preparation. The preparation method must ensure that the main chemical components of the crude drug are reflected in the fingerprint. The basis for selecting the preparation method should be explained. If the test product needs to be extracted and purified, the extraction solvent, extraction method, purification method, etc. should be examined. The extraction and purification method should strive to retain the chemical components in the test product to the maximum extent. Method, granularity, etc.

(4) Preparation of reference materials The basis for the selection of reference materials and the preparation of test samples shall be explained. According to the nature of the components contained in the test product, an appropriate reference substance or internal standard should be selected as the reference substance. The preparation of the reference should be performed according to the needs of the detection method, and the reason for the preparation should be explained.

(5) Detection method Select the corresponding detection method according to the characteristics of the test product and the physical and chemical properties of the chemical components contained. The basis for selecting the detection method and the principle of the detection method should be explained, and the methodological investigation data and related maps (including stability, precision and reproducibility) of the detection method should be determined. For crude drugs with many types of ingredients, such as one detection method or one map that cannot reflect the inherent characteristics of the crude drug, multiple detection methods or multiple measurement conditions of one detection method can be considered to establish multiple fingerprints. The chromatographic columns and thin-layer plates used to establish the fingerprint must be fixed to the manufacturer and model and specifications, and the reagents and measurement conditions must also be fixed accordingly. To establish a fingerprint using spectroscopy, the corresponding detection conditions must also be fixed. The stability test mainly examines the stability of the test product. Take the same test product and test it at different times, check the consistency of the relative retention time and peak area ratio of the chromatographic peaks, and determine the detection time. Precision test mainly examines the precision of the instrument. Take the same test sample and inject 5 or more consecutive injections to check the consistency of the relative retention time and peak area ratio of the chromatographic peaks. High-performance liquid chromatography and gas chromatography are used to formulate fingerprints. The chromatographic peaks that share a common peak area ratio are specified in the fingerprint. The relative standard deviation RSD of the peak area ratio must not be greater than 3%, and other methods must not be greater than 5%. For the test products tested by spectroscopic methods, corresponding investigations should be conducted with reference to chromatographic methods. The relative standard deviation RSD should not be greater than 3%. The reproducibility test mainly examines the reproducibility of the experimental method. Take more than 5 test samples of the same batch, prepare and test the test products according to the test product preparation and detection methods, and check the consistency of the relative retention time and peak area ratio of the chromatographic peaks. High-performance liquid chromatography and gas chromatography are used to formulate fingerprints. The chromatographic peaks that share a common peak area ratio are specified in the fingerprint. The relative standard deviation RSD of the peak area ratio must not be greater than 3%, and other methods must not be greater than 5%. For the test products tested by spectroscopic methods, corresponding investigations should be conducted with reference to chromatographic methods. The relative standard deviation RSD should not be greater than 3%.

(6) Fingerprint spectrum and technical parameters

Fingerprints are established based on the test results of the test product. Fingerprints prepared using high-performance liquid chromatography and gas chromatography generally have a recording time of one hour. For fingerprints prepared using thin-layer scanning, a map must be provided from the origin to the front of the solvent. The fingerprint spectrum must provide the full spectrum according to the corresponding regulations of various spectra. For samples with complex chemical composition types, multiple fingerprints can be established if necessary. The establishment of fingerprints should be based on the relevant parameters given by the test results of more than 10 batches of test products. The calibration of common fingerprint peaks uses a chromatographic method to formulate fingerprints. The relative retention time of fingerprint peaks must be calculated based on the retention time of the reference object. Based on the test results of more than 10 batches of test products, the common fingerprint peaks of the crude drugs were calibrated. Chromatography uses relative retention time to calibrate fingerprint peaks, and spectroscopy uses wavelength or wave number to calibrate fingerprint peaks. The ratio of the area of the shared fingerprint peaks uses the fingerprint of the reference substance as the reference object, and the area of the peak of the reference substance as 1, calculates the ratio of the area of the peaks of the common fingerprint to the area of the peak of the reference object; Take the peak area of one of the shared fingerprint peaks (a relatively large and stable shared peak is required) as 1, and calculate the ratio of the other shared fingerprint peak areas. The area ratio of each shared fingerprint peak must be relatively fixed. Comparing the ratio of the common peak areas in the test product spectrum of the crude drug to the ratio of the common peak areas in the fingerprint spectrum, the single peak area accounts for the common peaks with a total peak area of 20% or more, and the difference must not be greater than ± 20%; The peak area occupies 10% or more of the total peak area, and the difference between the common peaks less than 20% must not be greater than ± 25%. For the common peaks whose single peak area accounts for less than 10% of the total peak area, the peak area ratio is not required. The relative retention time must be calibrated. For the common peaks that have not reached the baseline separation, the total peak area of the group of peaks should be calculated as the peak area, and the relative retention time of each peak in the group should be calibrated. The average ratio should be calculated based on the ratio of the areas of the common fingerprint peaks in the spectrum of more than 10 batches of test products, and the test data of each batch of test products should be listed. Non-shared peak area Calculate the total area of non-shared peaks in the spectrum of more than 10 batches of test products and their percentage of total peak area, and list the test data of each batch of test products.

(7) Similarity evaluation of fingerprints

The similarity of the fingerprint spectrum requires the application of advanced mathematical methods to establish model calculations. Two algorithms are generally used, one is the correlation coefficient method and the other is the angle cosine method. Experts have developed fingerprint similarity evaluation software.

Biopharmaceutical examination

The inspection part of the quality standard for crude drugs refers to some impurities that may be incorporated into the crude drug and items related to the quality of the crude drug. Depending on the variety or specific situation, there are different inspection contents, which is one of the important items to ensure quality.

Related inspection items often include:

Impurity

Refers to medicinal materials whose base source is in compliance with the regulations, but whose properties or parts do not conform to the regulations; substances whose sources are different from the regulations; inorganic impurities such as sand, mud, dust, etc.

2. Proportion of medicinal part

To ensure the quality of crude drugs, some crude drugs need to specify the proportion of medicinal parts. For example, Andrographis paniculata should not be less than 35%.

3. Ash content

The ash has total ash and acid-insoluble ash, which is very important for determining the quality of crude drugs. Depending on the circumstances of the crude drug, one or both of them may be prescribed. The total ash content should be specified for medicinal materials that are easy to be mixed with mud or for crude drugs that are difficult to process and process and that are not easy to remove. Different sources of the same crude drug will have very different total ash contents. Therefore, it is necessary to determine the total ash limit after measuring the products from more producing areas (or more purchasing places). The total ash may not be specified if it is not easy to be mixed with mud or sand and the product is relatively smooth without processing.

General procedures and methods for student drug identification of crude drugs

Sampling of student medicine

Sampling of crude drugs refers to the method of selecting crude drug samples for verification. The representativeness of sampling directly affects the accuracy of the test results. Therefore, we must pay attention to all aspects of sampling.

1. Before sampling, pay attention to whether the product name, origin, specification level and package style are consistent. Check the completeness, cleanliness of the package, and whether there are water marks, mildew or other material pollution, etc., and keep detailed records. All packages with abnormal conditions shall be inspected separately.

2. The principle of extracting samples for verification from the same batch of crude drug packages is as follows: if the total number of crude drug packages is less than 100, 5 samples will be taken; 100 to 1000 samples will be sampled at 5%; if it is more than 1,000, samples will be taken at 1% ; Sampling of less than 5 pieces; for valuable crude drugs, no matter how many packages are sampled piece by piece.

3. For broken, powdered or less than 1cm crude drugs, samples can be taken with a sampler (probe). Each package should have at least 2 to 3 samples at different locations. The total amount of small packages should not be taken. Less than three times the experimental dosage; for packages with many packages, the sampling volume of each package is generally specified: 100 to 500 g of raw crude drugs; 25 g of powdered crude drugs; 5 to 10 g of valuable crude drugs; representative drugs of large size according to actual conditions sample. If the individual is large, it can be taken at different parts of the package (the package should be deeper than 10cm).

4. Mix the samples and mix well to obtain the total sample. For individual small crude drugs, they should be spread into squares, and the × should be drawn diagonally to divide them into quarters, and take two diagonally; then repeat the above operation several times until the last remaining amount is enough to complete This is the average sample until the necessary tests and the number of retained samples. For large crude drugs, average samples can be taken by other appropriate methods. The average sample amount should generally not be less than three times the amount required for experiments such as authenticity, purity, and good quality, that is, 1/3 for laboratory analysis, another 1/3 for review, and the remaining 1/3 is reserved Samples should be kept for at least one year.

Biopharmaceutical impurity inspection

Impurities in crude drugs refer to substances with the same source as the regulations, but their properties or parts do not conform to the regulations; substances with different sources and regulations; inorganic impurities such as gravel, mud, dust, etc. The inspection method can take a specified amount of sample, spread it out, observe with the naked eye or a magnifying lens (5-10 times), and sort out the impurities. If there are impurities that can be sieved, separate them through an appropriate sieve. Each impurity is then weighed separately to calculate its percentage in the sample. If the impurities mixed in the crude drug are similar to the genuine ones, and it is difficult to identify them from the appearance, microscopic and physical and chemical identification tests can be performed to prove that the impurities are included in the weight of the impurities. For individual large crude drugs, they can be opened if necessary, and checked for insect worms, mildew or deterioration. The amount of samples used for impurity inspection is generally weighed according to the crude drug sampling method.

Biopharmaceutical moisture determination

The determination of moisture is to ensure that the organism does not become mouldy or deteriorate because the moisture content exceeds the limit. Moisture measurement methods are commonly used drying method and toluene method. The raw medicinal samples used for measurement are generally broken into particles or fragments with a diameter not exceeding 3mm, and flowers, seeds, and fruit medicinal materials with a diameter and length of 3mm or less may not be broken.

1. Drying method is suitable for crude drugs with no or little volatile components. Take 2 5g of sample, flatten it in a flat weighing bottle dried to constant weight, the thickness should not exceed 5mm, and the loose sample should not exceed 10mm. Cover, place in a desiccator, cool for 30 minutes, accurately weigh, dry at the above temperature for 1 hour, cool, and weigh until the difference between two consecutive weighings does not exceed 5 mg. Calculate the percentage of moisture in the test product based on the weight lost.

Toluene method

It is suitable for crude drugs containing volatile components. It is directly measured with chemically pure toluene. If necessary, toluene can be added with a small amount of distilled water, shake it thoroughly, and then place it. The water layer is separated and discarded, and used after distillation. The device is shown in Figure 4-1. A is a 500ml short-necked round-bottomed flask; B is a moisture measuring tube; C is a straight condenser tube with an outer tube length of 40 cm. Before use, all instruments should be cleaned and dried in an oven. When measuring, take an appropriate amount of the sample (equivalent to about 1 to 4ml of water content), weigh it accurately, put it in A bottle, add about 200ml of toluene, and add glass beads if necessary. Connect the various parts of the instrument, add toluene from the top of the condensing tube to the narrow part that fills the B tube, and place the A bottle in an electric heating jacket or slowly heat it by other suitable methods. When the toluene begins to boil, adjust the temperature so that every second Distilled out 2 drops. When the water is completely distilled off, that is, when the amount of water in the calibration part of the measuring tube does not increase any more, flush the inside of the condensate tube with toluene, and then use a long brush saturated with toluene or other suitable methods to push down the toluene attached to the tube wall. Continue distillation for 5 minutes, allow to cool to room temperature, disassemble the device, if water adheres to the tube wall of tube B, push down with copper wire dipped in toluene, and place it to completely separate water from toluene (methylene blue powder can be added A little, to make the water blue for easy observation). Check the amount of water and calculate it as the percentage of water in the test product.

Biopharmaceutical vacuum drying method

Suitable for precious medicines containing volatile ingredients.12cm0.51cm30cm24g0.51g2.67kPa20mmHg24

10%

23g35g0.01g50060010%2ml

10ml105ml

14g0.01g250300ml100ml61820ml105330

(2) Hot dipping method: Take about 2 to 4 g of sample, weigh it to the exact weight (accurate to 0.01 g), place it in a 250 to 300 ml conical bottle, add 50 to 100 ml of water precisely, stopper tightly, weigh it, and let it stand After an hour, a reflux condenser was connected, heated to boiling, and kept slightly boiling for 1 hour. After allowing to cool, remove the conical flask, stopper tightly, weigh it, make up the lost weight with water, shake well, and filter through a drying filter. Precisely measure 25ml of the filtrate, place it in an evaporation dish that has been dried to a constant weight, evaporate to dryness on a water bath, and dry at 105 ° C for 3 hours. Place in a desiccator and cool for 30 minutes. Calculate the percentage of water-soluble extractives in the test article.

2. Determination of alcohol-soluble extractives

Take ethanol or methanol instead of water as the solvent. Perform the water-soluble leaching method (hot immersion method must be heated on a water bath).

3. Determination of ether-soluble extractives: Take 2 4g of sample, weigh it (accurate to 0.01g), put it in the fatty oil extractor of constant weight flask, use ether as solvent, heat in water bath for 4-6 hours, and let cool Rinse the reflux device with a small amount of ether. The washing solution is connected to a distillation flask. The ether is distilled off at low temperature, dried at 105 ° C for 3 hours, placed in a desiccator, cooled for 30 minutes, quickly weighed, and the test product is calculated based on the dried product. Percentage of ether-soluble extractives.

Determination of volatile oil in biopharmaceuticals

Applicable to crude drugs containing a large amount of volatile oil. The samples used for measurement must generally be crushed to pass through the No. 2 to No. 3 sieve, and mixed uniformly. The equipment is shown in Figure 4-2. (Note: The branching branch of the volatile oil in the device should be parallel to the reference line)

Assay method A method: applicable to the determination of volatile oils with a relative density of 1.0 or less. Take an appropriate amount of the sample (equivalent to 0.5 to 1.0 ml containing volatile oil) and stabilize the weight (accurate to 0.01 g). Place it in a 1000 ml flask, add 300 to 500 ml of water (or an appropriate amount) and a few glass beads. After shaking and mixing, connect Volatile oil tester and reflux condenser. Add water from the upper end of the condensate tube to fill the graduated portion of the volatile oil tester (with a scale of 0.1ml), and when it overflows into the flask, place it in an electric heating jacket or use other suitable methods to slowly heat to boiling, and maintain a slight boiling for about 5 hours , Until the amount of oil in the tester no longer increases, stop heating, leave it for a while, open the piston at the lower end of the tester, and slowly release the water until the upper end of the oil layer reaches 5mm above the scale 0 line. Leave it for more than 1 hour, then turn on the piston to lower the oil layer to the upper end just flush with the scale 0 line, read the amount of volatile oil, and calculate the percentage of volatile oil in the test product.

Method B: It is suitable for the determination of volatile oils with a relative density of 1.0 or more. Take approximately 300ml of water and a few glass beads, place it in a flask, and connect the volatile oil tester. Fill the scale with water from the top of the tester, and when it overflows into the flask, add 1ml of xylene with a pipette, and then connect a reflux condenser. . The contents of the flask were heated to boiling, and the distillation was continued at a speed such that the middle part of the condenser tube was kept in a cooled state at a degree. After 30 minutes, the heating was stopped, and the volume of xylene was read for more than 15 minutes. Then according to the A method, "take the appropriate amount of the sample" and determine according to the law, subtract the amount of xylene from the amount of the oil layer, that is, the amount of volatile oil, and then calculate the percentage of the test product containing volatile oil.