What is a Codicil?

The Pharmacopoeia is a national code of drug standards and specifications. It is generally compiled, promulgated and implemented by the State Drug Administration. The international pharmacopoeia is prepared by a recognized international organization or the country concerned. The pharmacopoeia evolved from the compilation of herbal medicine, pharmacology, and prescriptions. An important feature of the Pharmacopoeia is its legality and standardization of style.

Chinese name: Pharmacopoeia
Foreign name: pharmacopoeia
Concept: National Code of Drug Standards and Specifications

Hosting compilation unit: State Drug Administration
Important features: Legality and system standardization
Chinese Pharmacopoeia: See text

Pharmacopoeia

Pharmacopoeia is a national code for drug standards and specifications. It is generally compiled, promulgated and implemented by the National Drug Administration. International Pharmacopoeia is prepared by a recognized international organization or the country concerned. Formulating drug standards plays a very important role in strengthening the supervision and management of drug quality, ensuring quality, ensuring the safety and effectiveness of drug use, and protecting people's health. Drug standards are an important part of modern drug production and quality management, and they are the legal basis for drug production, supply, use, and supervision and management. The connotation of drug quality includes three aspects: authenticity, purity, and good quality. The three concentrated manifestations are effectiveness and safety in use. Therefore, drug standards generally include the following: legal name, source, character, identification, purity check, content (potency or activity) determination, category, dosage, specification, storage, preparation, and so on.

The pharmacopoeia evolved from the compilation of herbal medicine, pharmacology, and prescriptions. An important feature of the Pharmacopoeia is its legality and standardization of style. The earliest pharmacopoeia in China is more commonly recognized as the "New Revised Materia Medica" compiled by 22 people including Li Chunfeng and Su Jing of the Tang Dynasty in 659 AD. The 54 volumes of the book contain 844 kinds of drugs, which is the earliest legal pharmacopoeia in the world. Advances in typography in the 15th century promoted the development of modern European pharmacopoeia. Many countries have developed their own pharmacopoeias. The Florence Prescription Collection, published by the Florence Academy in 1498, is generally regarded as the first legal pharmacopoeia in Europe. Since then, many cities have compiled legally binding pharmacopoeias. Among them, the "Medical Recipe" edited by Dr. Valerius of Nuremberg won a high reputation, was recognized by the Nuremberg authorities, and was designated as the first "Nuremberg Pharmacopoeia" to be published in 1546. Under the influence of the "Nuremberg Pharmacopoeia", Pharmacopoeia have also been introduced in Augsburg, Antwerp, Lyon, Basel, Valencia, Cologne, Paris and Amsterdam. This progress marks a new stage in the transformation of European pharmacopoeia into legal national pharmacopoeia.

By the early 1990s, at least 38 countries in the world had compiled national pharmacopoeias. In addition, there are three regional pharmacopoeia and the International Pharmacopoeia compiled by the World Health Organization (WHO). Here are some famous pharmacopoeias.

Pharmacopoeia

24 edition of the United States Pharmacopeia (USP) in 2000

19 National Formulary (NF) 2000 edition

USP (25) NF (20) Asian Edition 2002 first published

British Pharmacopoeia (BP) 2009 Edition

Japan Pharmacy Formula JP (13)

European Pharmacopoeia (Ph.Eup) Third Edition 2000 Supplement

(Ch.P) Chinese Pharmacopoeia (Ch.P)

Pharmacopoeia overview

From the Chinese Pharmacopoeia published in 1930. Since the founding of the People's Republic of China in 1949, it has compiled ten editions of the Pharmacopoeia of the People's Republic of China (referred to as the "Chinese Pharmacopoeia") in 1953, 1963, 1977, 1985, 1990, 1995, 2000, 2005, 2010, and 2015.

After the founding of the People's Republic of China on October 1, 1949, the party and government were very concerned about people's medical and health care work. In November of that year, the Ministry of Health convened relevant medical experts in Beijing to discuss the compilation of pharmacopoeia. In January 1950, Professor Meng Mu, an expert in pharmaceutical preparations in Shanghai from the Ministry of Health, was responsible for setting up the Chinese Pharmacopoeia Compilation Committee and the executive committee to handle daily work, and to prepare a new Chinese Pharmacopoeia.

In April 1950, a Pharmacopoeia workshop was held in Shanghai to discuss the principles and recommended varieties of Pharmacopoeia. According to the instructions of the Ministry of Health, the New China Pharmacopoeia was combined with national conditions to compile a national and scientific Popular pharmacopoeia. Subsequently, the Ministry of Health hired 49 members of the Pharmacopoeia, divided into 8 groups of nouns, chemical drugs, preparations, botanicals, biological products, animal medicine, pharmacology, and dosage. Another 35 members of the communication committee were hired to establish the first Chinese Pharmacopoeia compilation committee. . Minister of Health Li Dequan is the chairman.

The first plenary session of the first Chinese Pharmacopoeia Compilation Committee was held in Beijing from April 24th to 28th, 1951. The meeting made a decision on the name of the Pharmacopoeia, the varieties included, the proper nouns, the problems of weights and measures, and the format arrangement. Based on the opinions discussed in the plenary, the Secretary will revise the draft Pharmacopoeia. After the draft was submitted to the Ministry of Health for approval by the Culture and Education Committee of the Government Affairs Administration, the 1953 edition of the Chinese Pharmacopoeia was compiled and published by the Ministry of Health.

The 1953 edition of the Pharmacopoeia contained a total of 531 drugs, of which 215 were chemical drugs, 65 were botanicals and oils, 13 were animal drugs, 2 were antibiotics, 25 were biological products, and 211 were various preparations. After the Pharmacopoeia was published, the first supplement of the 1953 edition of the Chinese Pharmacopoeia was published in 1957. In 1955, the second Pharmacopoeia Committee was established by the Ministry of Health, employing 49 members and 68 communication members. The third Pharmacopoeia Committee was established in 1957. 80 members were hired. Professor Tang Tenghan, a pharmacy expert, was the chairman of the current committee (no communication committee member). The first general meeting was held in Beijing from July 28 to August 5 of the same year. The committee discussed that all directors of the Ministry of Health Li De made a report on the work of the Pharmacopoeia, in particular pointing out that the first edition of the Chinese Pharmacopoeia did not contain the traditional Chinese medicine used by the general public, which was a major flaw. On the basis of the summary work, the meeting adopted the principles for formulating the pharmacopoeia, discussed the nature and role of the pharmacopoeia, and revised the charter of the committee. The meeting agreed that eligible Chinese medicines should be included in the pharmacopoeia. On August 27, the Ministry of Health approved the committee to set up six special committees and terminology groups in pharmacology and medicine, chemicals, pharmacy, biochemical drugs, biopharmaceuticals, and biological products. The Pharmacopoeia Committee set up a standing committee, and the daily working organization was renamed the secretary's office. In 1958, the Standing Committee researched and approved by the Ministry of Health, and hired 8 Chinese medicine experts and 3 Chinese medicine experts to form a special committee of Chinese medicine, and organized relevant provinces and cities of Chinese medicine experts to draft traditional Chinese medicine based on the theory and experience of traditional Chinese medicine. And the standard of Chinese medicine formula (ie Chinese medicine).

The second plenary session of the committee was held in Beijing from June 25th to July 5th, 1959. The meeting mainly considered the draft of the new Pharmacopoeia and determined the varieties to be included. After the draft was revised and supplemented, it was reviewed and approved by the special committees. The draft was submitted for review in 1962. It was submitted to the State Council for approval and printed. On January 26, 1965, the Ministry of Health promulgated the 1963 edition of the Chinese Pharmacopoeia, and issued notifications and enforcement measures.

The 1963 edition of the Pharmacopoeia contained a total of 1,310 medicines, divided into one, two and two, each with its own rules and related appendices. One section contains 446 kinds of Chinese medicinal materials commonly used in traditional Chinese medicine and 197 kinds of traditional Chinese medicine preparations; the second section contains 667 kinds of chemical drugs. In addition, one documented the "functions and indications" of the drug, and the second document added the "functions and uses" of the drug.

In 1966, due to the turmoil of the Cultural Revolution, the work of the Pharmacopoeia Committee was suspended. On April 28, 1972, the State Council approved the Ministry of Health to agree to resume the Pharmacopoeia Committee, with the participation of four ministries (Ministry of Health, Ministry of Fuel Chemical Industry, Ministry of Commerce, and General Ministry of Health of the PLA), with the Ministry of Health taking the lead. Accordingly, the National New Pharmacopoeia Working Conference was held in Beijing from May 31 to June 10 of the same year. The meeting was attended by drug inspections, pharmaceutical administration and related matters in various provinces (autonomous regions and municipalities). The unit represents a total of 88 people. This meeting focused on the guidelines, methods, tasks, and requirements for compiling a pharmacopoeia, exchanged work experience, determined a plan for compiling a new pharmacopoeia, and divided the work into the drafting tasks. In April 1973, the Second National Pharmacopoeia Working Conference was held in Beijing to discuss the formulation of some principles and requirements of the Pharmacopoeia, as well as standard sample drafts and drafting instructions for Chinese and Western medicines, and adjusted the drafting tasks according to the main origin of the medicinal materials and the production of the medicines. On October 4, 1979, the Ministry of Health promulgated the 1977 edition of the Chinese Pharmacopoeia, which was implemented on January 1, 1980. The 1977 edition of the Pharmacopoeia contained 1,925 medicines. One contains 882 kinds of Chinese herbal medicines (including ethnic medicinal herbs), Chinese herbal extracts, vegetable oils, and some single-flavor medicinal preparations, and 270 prescriptions (including ethnic minority medicinal recipes), totaling 1 152; two Contains 773 kinds of chemicals, biological products, etc.

In 1979, the Ministry of Health hired 112 members to set up the Fourth Pharmacopoeia Committee, and the Minister of Health Qian Xinzhong also served as the chairman. The first meeting of the Committee of the Whole was held in Beijing from November 22nd to 28th of the same year. The meeting discussed and revised the committee's charter, drug standards management measures and work plan. The committee is divided into 10 professional groups: Chinese medicine, Chinese medicine, medicine and pharmacology, chemical medicine, biochemical medicine, pharmacy, antibiotics, biological products, radiopharmaceuticals and nouns. The relevant professional groups recommend the varieties included in the new pharmacopoeia respectively. The Chinese medicine professional group is responsible for reviewing and formulating the range of varieties included in the first section; the medical and pharmacological professional group is responsible for reviewing and formulating the range of varieties included in the second section; Autonomous regions and municipalities) are responsible for drafting standards. The Office of the Pharmacopoeia Committee organizes cross-checks. Some projects are organized by thematic collaboration groups and drafted after experimental research. The draft standards are approved by members of the relevant professional groups and invited by relevant drug inspection laboratories and pharmaceutical factories. After discussion and deliberation, the representative reports to the Ministry of Health for approval. The 1985 edition of the Chinese Pharmacopoeia was published in September 1985. Effective April 1, 1986. This edition contains a total of 1489 medicines. One contained 506 kinds of Chinese medicinal materials, vegetable oils and single-flavor preparations, and 207 kinds of Chinese medicine prescriptions, a total of 713 kinds; the second contained 776 kinds of chemicals, biological products, and so on.

The "Pharmaceutical Administration Law of the People's Republic of China" was formally implemented on July 1, 1985, which stipulates that "drugs must meet national drug standards or drug standards of provinces, autonomous regions, and municipalities." The "Pharmacopoeia of the People's Republic of China" and drug standards promulgated by the State Council's health administrative department are specified as national drug standards. "The Pharmacopoeia Committee of the Health Administration Department of the State Council is responsible for organizing the formulation and revision of national drug standards." The legal nature of drug standards and the tasks of the Pharmacopoeia Committee were further determined.

In 1986, the Ministry of Health hired 150 members to establish the fifth Pharmacopoeia Committee in accordance with the Statutes of the Pharmacopoeia Committee. The Minister of Health Cui Yueli served as the chairman and the permanent office was changed to the Secretary-General system. The first session of the Fifth Committee of the Whole was held from May 5th to 8th in the same year, discussing and revising the charter of the committee, adopted the standard work plan during the Seventh Five-Year Plan period, and determined the guidelines and principles required for the preparation of the 1990 edition of the Chinese Pharmacopoeia. . Hold professional conferences on Chinese herbal medicines, traditional Chinese medicine preparations, chemical drugs, antibiotics, biochemical drugs, and pharmacology, respectively, to arrange drafting and scientific research tasks. A supplement to the 1985 edition of the Chinese Pharmacopoeia was published in November 1987, with 23 new varieties, 172 revised varieties, and 21 items in the appendix. In October 1988, the first English version of the Chinese Pharmacopoeia was published in 1985. In the same year, the second annotated selection of the Pharmacopoeia was published. In March 1989, the first draft of the 1990 version of the Pharmacopoeia standard drafted by the localities was basically completed, and the permanent body of the Pharmacopoeia Committee began to organize review and edit processing. In December of the same year, an expanded meeting of the chairman, deputy chairman, and the heads of the professional committees of the Pharmacopoeia Committee was held in Beijing for review, and printed after approval by the Ministry of Health. The 1990 edition of the Chinese Pharmacopoeia promulgated by the Ministry of Health on December 3, 1990 will be implemented from July 1, 1991.

This edition of the Pharmacopoeia is divided into one, two and two, containing a total of 1751 varieties. One contained 784 species, including 509 species of Chinese medicinal materials and vegetable oils and fats, and 275 kinds of traditional Chinese medicine prescriptions and single-flavor preparations; the second part contained 967 species of chemical drugs and biological products. Compared with the 1985 edition of the Pharmacopoeia, 80 species were added in one edition and 213 species were added in the second edition (including the 1985 edition of the Pharmacopoeia, one of which was moved to 5 species); 25 species were deleted (one was 3 species, and the second was 22 species). ); The drug name has been appropriately revised according to the actual situation. The "functions and uses" and "usages and dosages" prescribed under the two pharmacopoeia categories were changed to "categories" and "dose" respectively, and the book "Clinical Medications" was organized to guide clinical medication. The infrared absorption spectra of related varieties are published separately in the "Infrared Spectral Collection of Drugs", which will not be printed in the appendix of this edition of the Pharmacopoeia.

In 1991, the Sixth Pharmacopoeia Committee was established. The Ministry of Health hired a total of 168 members, and Minister Chen Minzhang served as the chairman. The first full committee meeting was held from May 16th to 18th of the same year. The committee's charter and the design of the 1995 edition of the Chinese Pharmacopoeia were discussed and approved. A standing committee consisting of 11 members including the chairman, deputy chairman, and experts was established. Committee. 13 professional groups, namely: Chinese medicine professional group, Chinese herbal medicine professional group, Chinese patent medicine professional group, Western medicine professional group, pharmacology professional group, chemical medicine professional group, chemical medicine professional group two, chemical medicine professional group three, antibiotics professional Group, professional group of biochemical drugs, professional group of biological products, professional group of radioactive drugs, professional group of drug nouns. After the meeting, each professional group held an enlarged meeting of professional group members to arrange for the implementation of the tasks proposed by the plenary.

The 1995 edition of the Chinese Pharmacopoeia in 1993 and the first draft of the appendix were sent to various places as the basis for drafting and revising the text standards. In July 1994, the drafting of standards was basically completed in various places, and the review work was organized by the professional committees of the Pharmacopoeia Committee. It was submitted to the Standing Committee's enlarged meeting for discussion and consideration on November 29, 1994. It was adopted in principle and reported to the Ministry of Health for approval and printing. The Ministry of Health approved the promulgation of the 1995 edition of the Chinese Pharmacopoeia, which will be implemented on April 1, 1996.

This edition contains a total of 2375 species. One contains 920 species, of which 522 are Chinese medicinal materials, vegetable oils and fats, and 398 are Chinese herbal formulas and single-flavor preparations; the second contains 1,455 species, including chemical drugs, antibiotics, biochemical drugs, radiopharmaceuticals, biological products and Excipients, etc. One newly added 142 varieties and two new varieties 4 ". The two foreign names of the medicines were changed to English and the Latin names were cancelled; the Chinese names contained only the legal common names of the medicines, and were no longer listed as sub-names. Volume I of Drug Infrared Spectroscopy, Volume I (1995 edition). The book "Clinical Medications" has been revised and published simultaneously with the 1995 edition of the Chinese Pharmacopoeia, and has been approved by the Ministry of Health. The "indications" and "dose" sections are included as The pharmaceutical administration and production departments publicize the basis for the use and management of drugs.

In addition to completing the compilation of the 1995 edition of the Pharmacopoeia, this year's Pharmacopoeia Committee also compiled and published the first and second supplements of the 1990 edition of the Chinese Pharmacopoeia in 1992 and 1993, with two notes and a selection of notes. Ancillary series of standards, such as the Collections, Color Atlas of Traditional Chinese Medicine Thin Layer Chromatography, and the General Names of Chinese Drugs. The 1990 edition of the Chinese Pharmacopoeia was also published in July 1993.

In order to strengthen the national drug standards work, on May 21, 1993, the Ministry of Health decided to separate the Pharmacopoeia Commission's permanent establishment from the China Pharmaceutical and Biological Products Testing Institute as a direct unit of the Ministry of Health. This is a major reform in the history of the Pharmacopoeia Commission.

Approved by the Ministry of Health in May 1996, the Seventh Pharmacopoeia Committee was established, consisting of 204 members hired by the Ministry of Health, including 18 honorary members, and Minister Chen Minzhang concurrently serving as the chairman. In September 1998, according to the Chinese Office (1998) No. 32: The Pharmacopoeia Committee of the Ministry of Health was renamed the National Pharmacopoeia Committee, and it was established and transferred to the administration of the State Drug Administration. Due to changes in the management system and the death of Minister Chen Minzhang in March 1999, after obtaining the consent of the relevant leadership, in accordance with the spirit of the Charter of the Seventh Pharmacopoeia Committee, the Standing Committee of the Seventh Pharmacopoeia Committee agreed in December 1999 to adjust the director Member and Deputy Chairman. There are 16 professional committees in this session, namely: Chinese Medicine Professional Committee, Chinese Medicine First Professional Committee, Chinese Medicine Second Professional Committee, Chinese Medicine Third Professional Committee, Chinese Medicine Fourth Professional Committee, Medical Professional Committee, Drug Nomenclature Professional Committee, Appendix Professional Committee, Preparation Professional Committee, Pharmacological Professional Committee, Chemical Drug First Professional Committee, Chemical Drug Second Professional Committee, Antibiotic Professional Committee, Biochemical Drug Professional Committee, Radiopharmaceutical Professional Committee, Biological Products Professional Committee.

The first meeting of the Standing Committee of the Seventh Pharmacopoeia Committee was convened in 1996, and the "Chinese Pharmacopoeia 2000 Design Plan" proposed by this Pharmacopoeia Committee was adopted. One established "Outstanding Features and Improved Foothold", and the second established The guiding ideology of "combining catch-up with national conditions, combining advanced with characteristics". According to the design plan proposed by this session of the committee, since October 1996, the professional committees have held meetings to implement the tasks proposed by the design plan and work separately. At the end of 1997, the amendments to the appendix and the general rules for preparations were first completed, and all drafting units were issued for comments. At the end of 1998, the first draft of the Pharmacopoeia was completed. After further consultation with all relevant parties throughout the country, by the end of October 1999, 16 professional committee review meetings had been held. The 2000 edition of the Chinese Pharmacopoeia was deliberated and approved by the Standing Committee of the Seventh Pharmacopoeia Committee in December 1999, and was reported to the State Drug Administration for approval for publication.

The 2000 edition of the Pharmacopoeia contained a total of 2691 drugs, one of which contained 992 drugs and two of which contained 1,699 drugs. A total of 399 new varieties and 562 new varieties were revised in the first two sections. The appendix of this edition of the Pharmacopoeia has been greatly improved and improved. One appendix adds 10 appendixes and the revised appendix 31 appendixes; the second appendix adds 27 appendixes and revises 32 appendixes. Six appendixes including the verification requirements for the analysis methods of pharmaceutical standards are included for the first time in the two appendices, which play a guiding role in unifying and standardizing the standard testing methods for pharmaceuticals. Modern analytical techniques have been further expanded in this edition of the Pharmacopoeia. The Seventh Pharmacopoeia Committee also completed the 1995 Supplement of the Chinese Pharmacopoeia, the 1998 Supplement, the 1998 General Name of Chinese Medicines (1998 Supplement), and the "Infrared Spectra of Drugs" Collection "(volume two)," Clinical Medications "(third edition). The English version of the 1995 edition of the Chinese Pharmacopoeia was completed in 1997. In order to strengthen international cooperation and communication, the 7th Pharmacopoeia Committee also decided to publish the 2000 and Chinese editions of the Chinese Pharmacopoeia simultaneously.

The contents of the "dose" and "attention" in previous versions of the Pharmacopoeia are too simple to accurately reflect the actual situation of clinical use. According to the proposal of the "Chinese Pharmacopoeia 2000 Version Design Plan", this part of the Pharmacopoeia canceled this. Two items, the relevant content of which was moved to the "Chinese Pharmacopoeia" 2000 edition "Clinical Medication" book.

In October 2002, with the approval of the State Drug Administration (renamed the State Food and Drug Administration in September 2003), the Eighth Pharmacopoeia Commission was established. It is composed of 312 members hired by the State Drug Administration and no more honorary members. Zheng Xiaoying, director of the State Drug Administration, also serves as chairman. The former Standing Committee was renamed the Executive Committee and was authorized by the General Assembly to review and approve major issues of the Chinese Pharmacopoeia and national drug standards. The committee has 24 professional committees. On the basis of the previous committee, the National Medicine Professional Committee (preparatory committee), the Microbiological Professional Committee, the Pharmaceutical Packaging Materials and Excipients Professional Committee were added; the original Biological Products Professional Committee was expanded to the Blood Products Professional Committee, the Viral Products Professional Committee, and the Bacteria. Product Professional Committee, Somatic Cell Therapy and Gene Therapy Professional Committee, Recombinant Product Professional Committee and In vitro Diagnostic Biological Reagent Professional Committee.

In October 2002, the eighth session of the General Assembly of the Pharmacopoeia Committee and the first meeting of the Executive Committee adopted the "Chinese Pharmacopoeia 2005 Design Plan" proposed by the current Pharmacopoeia Committee. The design plan clarified the policy of combining inheritance and development, theory and practice; determined the compiling principles of pharmacopoeia such as "scientific, practical, and standardized"; decided to incorporate the "Chinese Biological Product Regulations" into the human pharmacopoeia and set it as the three pharmacopoeia; and Compilation of the first Chinese patent medicine "Clinical Medications".

Since November 2002, various professional committees have held meetings to arrange the tasks proposed by the design scheme and work separately. In July 2003, the first draft of the appendix was completed and the relevant units were consulted. At the beginning of 2004, the appendix of the Pharmacopoeia and the first draft of the variety were basically completed. The contents of the amendments were successively published on the website of the National Pharmacopoeia Commission for 3 months, and opinions from all relevant parties in the country were sought. From June to August, the professional committees successively held the review draft meetings. In September, the 2005 edition of the Chinese Pharmacopoeia was reviewed and approved by the Executive Committee of the Eighth Pharmacopoeia Committee. In December, it was reported to the State Food and Drug Administration for approval and promulgation. . Varieties included in this edition of the Pharmacopoeia have increased significantly. A total of 3,214 species were included, of which 525 were newly added. The first part of the Pharmacopoeia contains 1,146 species, of which 154 are newly added and 453 are revised; the second part of the Pharmacopoeia contains 1967 species, of which 327 are newly added, and 522 are revised; the third part of the Pharmacopoeia contains 101 species, of which 44 are new 57 revisions. There are 9 varieties of Chinese Pharmacopoeia included in the 2000 edition and not included in this edition. There are a total of 123 species in the 2000 edition of the "Chinese Biological Product Regulations" and the 2002 supplements which were not included in the human pharmacopoeia.

In this edition of the Pharmacopoeia, there are 98 appendixes in the Pharmacopoeia, of which 12 are new, 48 are revised, and 1 is deleted; Pharmacopoeia 2 is 137, of which 13 are new, 65 are revised, and 1 is deleted; There are 140 pharmacopoeia, of which 62 are new, 78 are revised, and 1 is deleted. The appendices commonly used in Parts I, II and III are included in each ministry and coordinated.

This edition of the Pharmacopoeia, under the active advocacy of the chairman, has paid more attention to the issue of drug safety. The Pharmacopoeia 1 uses atomic absorption and inductively coupled plasma mass spectrometry to increase the determination of harmful elements (lead, cadmium, arsenic, mercury, copper) and specifies the limits of harmful elements; the Pharmacopeia 1 also adds the safety inspection of traditional Chinese medicine injections Guidelines for the application of law. There are 126 intravenous injections in the second part of the Pharmacopoeia. The insoluble particulate test has been updated, and the number of bacterial endotoxin tests has been revised to 112. The residual solvent determination method has introduced internationally harmonized limits on residual solvents and has 24 raw materials. Drugs have been updated for the inspection of residual solvents; the second part of the Pharmacopoeia has also added guidelines for the analysis of drug impurities, positrons, and quality control guidelines for radioactive drugs of plutonium [99mm Tc]. The third part of the Pharmacopoeia has revised the reverse transcriptase activity test method and the determination method of aluminum albumin residue in human blood. The detection methods such as bovine serum albumin residue and CHO cell protein residue have also been improved. This edition of the Pharmacopoeia combines the current state of China's pharmaceutical industry and the actual situation of clinical use of medicines. The original "Clarity Inspection Rules and Judgment Standards" promulgated by the Ministry of Health was revised to the "Visible Foreign Body Inspection Law" to enhance the safety of medications such as injections.

This edition of the Pharmacopoeia adheres to the consistent principle of environmental protection, and uses other solvents as much as possible to replace harmful solvents such as benzene in the varieties. This edition of the Pharmacopoeia, based on the theory of syndrome differentiation and treatment of traditional Chinese medicine, scientifically regulates the [functions and indications] under the standards of proprietary Chinese medicines contained in it, and provides a guarantee for accurate understanding of the functional indications and reasonable use of traditional Chinese medicines, and promotes traditional Chinese medicine in Healthy development in the new era.

Three editions of this edition of the Pharmacopoeia are derived from the "Chinese Biological Product Regulations". Since 1951, six editions of this regulation have been promulgated and implemented, which are 1951 and 1952 revised editions, 1959 edition, 1979 edition, 1990 edition and 1993 edition (diagnostic products), 1995 edition, 2000 edition and 2002 supplement this. In 2002, the first English version of the Chinese Biological Product Regulations (2000 edition) was translated and published.

The Eighth Pharmacopoeia Committee also completed the 2002 Supplement of the Chinese Pharmacopoeia, the 2002 Supplement, the 2004 Supplement, the Generic Name of Chinese Medicines (2005 Edition), the Infrared Spectroscopy of Medicines (Volume III), and Clinical Medicine Notice "(Chinese patent medicine first edition, chemical medicine fourth edition). In 2005, the English version of the 2005 edition of the Chinese Pharmacopoeia was completed. In order to strengthen international cooperation and exchanges, the first Sino-US Pharmacopoeia Forum was jointly held with the United States Pharmacopeia Commission during the current session of the Committee.

In order to strengthen and improve the efficiency and level of national standards, the permanent establishment has completed the construction of office automation and standards databases, and has implemented computer network retrieval and query and statistical analysis of published standards.

One of the characteristics of "Chinese Pharmacopoeia" is that it inherits the achievements of traditional medicine and realizes the combination of Chinese and Western medicine.

The Pharmacopoeia is revised every 5 years, and the current Chinese Pharmacopoeia is the 2015 edition.

2015 Introduction to Chinese Pharmacopoeia 2015 Edition:

The 2015 edition of the Pharmacopoeia of the People's Republic of China (referred to as the "Chinese Pharmacopoeia") is the tenth edition of the Pharmacopoeia. In accordance with the guiding ideology, basic principles, mission objectives and specific requirements established by the Pharmacopoeia Compilation Outline reviewed and approved by the Tenth Pharmacopoeia Commission and the General Assembly, under the leadership of the State Food and Drug Administration, drug inspection agencies at all levels, With the strong support and assistance of scientific research institutes and universities, and the active participation and cooperation of various pharmaceutical manufacturers, the hard work and unremitting efforts of all members and staff of permanent institutions successfully completed the 2015 edition of the Chinese Pharmacopoeia. Preparation of tasks. On February 4, 2015, the 10th Pharmacopoeia Committee Executive Committee reviewed and approved this version of the Pharmacopoeia. It was approved and promulgated by the State Food and Drug Administration on June 5, 2015, and will be implemented from December 1, 2015.
The 2015 edition of the Chinese Pharmacopoeia consists of one, two, three, and four books, and contains a total of 5,608 varieties, of which 1,082 are new. A section contains medicinal materials and decoction pieces, vegetable oils and extracts, formulated preparations and single-flavor preparations, etc. There are a total of 2598 species, of which 440 are new, 517 are revised, and 7 are not included. The second part contained 2,603 kinds of chemical drugs, antibiotics, biochemical drugs, and radioactive drugs, of which 492 were newly added, 415 were revised, and 28 were not included. The three contain 137 species of biological products, of which 13 are newly added, 105 are revised, and 6 are not contained. In order to solve the long-term repeated inclusion of pharmacopoeia testing methods and the inconsistencies, inconsistencies, and irregularities among the methods, this edition of the Pharmacopoeia integrates the common appendixes of each pharmacopoeia and renames the original appendixes to general principles, including general principles of preparations, testing methods, and standards. Substance, reagent testing and guidelines. Re-establish a standardized coding system, and for the first time, separate the General Principles and Pharmaceutical Excipients into four parts of the Chinese Pharmacopoeia. There are 317 general rules contained in the four books, including 38 general rules for preparations, 240 test methods, 30 guidelines, 9 general standards for reference materials and test solutions, and 270 medicinal excipients, of which 137 are new and 97 are revised. Species, not 2 species.
The characteristics of this edition of the Pharmacopoeia are mainly reflected in:
The number of loaded species has increased significantly. The scope of the contained varieties has been further expanded, and the national biological drug list has been fully covered with biological products, and the coverage rate of traditional Chinese medicine and chemical medicine has reached over 90%. Intensified adjustments were made to varieties with incomplete standards, years of non-production, many clinical adverse reactions, and unreasonable dosage forms. This edition of the Pharmacopoeia no longer contains a total of 43 varieties of the 2010 edition.
The Pharmacopoeia standard system has been improved. The appendixes of the past pharmacopoeia are integrated into four pharmacopoeia of this edition. The pharmacopoeia standard system with general requirements as general requirements, general rules as basic provisions, and text as specific requirements was improved. For the first time, the Guidelines for the Preparation of National Drug Standard Substances, General Requirements for Pharmaceutical Packaging Materials, and Medicinal Glass Materials and Containers were included, and formed to cover APIs and their preparations, pharmaceutical excipients, pharmaceutical packaging materials, reference materials, etc. A more comprehensive, systematic and standardized pharmacopoeia standard system.
Expanded application of modern analytical techniques. On the basis of retaining conventional detection methods, this edition of the Pharmacopoeia further expands the application of new technologies and methods to improve detection sensitivity, specificity and stability. Use liquid chromatography-tandem mass spectrometry, molecular biology detection technology, high performance liquid chromatography-inductively coupled plasma mass spectrometry, etc. for quality control of traditional Chinese medicine. Supercritical fluid chromatography, critical point chromatography, powder X-ray diffraction and other methods are used for quality control of chemical drugs. Capillary electrophoresis was used to determine the molecular size isomers of recombinant monoclonal antibody products, and the size distribution of antitoxin and antiserum products was determined by high performance liquid chromatography. In terms of detection technology reserves, guidance methods such as DNA barcode molecular identification method, pigment determination method, mycotoxin determination method in Chinese medicine, near-infrared spectrophotometry, and gene chip-based drug evaluation technology have been established.
Drug safety protection was further improved. Improved the "General Principles for the Verification of Medicinal Materials and Decoction Pieces", "General Principles for Processing" and "General Principles for Medicinal Excipients"; Added "National General Standards for Pharmaceutical Standard Materials", "Regulations on Quality Control of Raw Materials and Excipients for the Production of Biological Products", "General Introduction to Human Vaccines", " "General Recombinant Monoclonal Antibody Products for Human Use" and other relevant guidelines were added, including microparticle preparations, research on crystalline forms of pharmaceuticals, quality control of crystalline forms, and establishment of limits for harmful residues of traditional Chinese medicine. The first set the limit standards for sulfur dioxide residues in Chinese medicinal materials and decoction pieces, established the limit standards for harmful elements in marine drug standards such as pearls, seaweed, and formulated 16 pesticide residues such as organochlorine in ginseng and American ginseng standards. Ren and other 14 flavors of aflatoxin-infected medicinal materials and decoction pieces have added "aflatoxin" inspection items and limit standards. The second part further strengthened the control of related substances, strengthened the system applicability requirements of the method, and also increased the structural information of about 500 impurities; increased the control of chiral impurities; intravenous infusion and eye drops, etc., increased osmotic pressure The detection of molar concentration increases the requirements for the control of bacteriostatic agents in injections and eye drops. The third part strengthens the quality control of raw materials and auxiliary materials for the production of biological products, regulates the use of preservatives, and strengthens the control of residual solvents; increases the determination of osmolality of vaccine products, increases the sequencing of whole gene sequences of virus seed batches, and strictly restricts bacterial endotoxins Check the limits.
Drug effectiveness control was further improved. The testing methods were comprehensively revised. A part of Chinese medicinal materials has been added with special microscopic identification inspection, characteristic amino acid content determination, etc .; characteristic maps have been established in more than 30 standards such as Salvia miltiorrhiza. The second part uses ion chromatography to detect the acid ion content in the sulfate or hydrochloride bulk drug; it uses a more specific and more accurate method to determine the content of the preparation; it adds revised dissolution and release check methods to strengthen oral administration Control of the effectiveness of solid preparations and sustained-release preparations.
The standard level of medicinal excipients has been significantly improved. This edition of the Pharmacopoeia contains more serialized and multi-standardized pharmaceutical excipients to meet the needs of pharmaceutical production. It has added 21 grades of excipients for injection. Strengthen the safety control of medicinal excipients, such as increasing control requirements for residual solvents. Pay more attention to the functional control of excipients, such as adding porosity, powder fineness, powder flow, specific surface area, viscosity and other inspection items, and strengthen the requirements for research on the applicability of pharmaceutical excipient standards.
Further strengthen the guiding role of Pharmacopoeia standards. This edition of the Pharmacopoeia strengthens the guiding role of drug quality control through the selection and adjustment of varieties, the inclusion of advanced detection methods, and the formulation of technical guidelines; at the same time, it closely follows the trend of international drug quality control and standard development and takes into account China In terms of the actual status of drug production, in terms of inspection items and limit settings, it is necessary to ensure the safety of public medications and meet the availability of public medications, thereby guiding the healthy and scientific development of China's pharmaceutical industry.
This edition of the Pharmacopoeia continues to uphold the concepts of protecting wild resources and the natural environment, adhering to the sustainable development of traditional Chinese medicine, advocating green standards, and no longer adding new proprietary Chinese patent medicines containing endangered species or fossils such as leopard bone, antelope horns, dragon bones, dragon teeth, etc. in the prescription. ; Promote alternative use of toxic solvents in detection reagents, such as eliminating the use of benzene and mercury-containing reagents to reduce pollution to the environment and laboratory personnel.
The formulation of the Pharmacopoeia is more open, transparent and orderly. The compilation of this edition of the Pharmacopoeia has always adhered to the principles of openness, fairness and impartiality. The permanent establishment of the Pharmacopoeia Commission introduced the IS09001 quality management system into the entire process of compiling the pharmacopoeia for the first time. Through continuous improvement and improvement of the management system of the Pharmacopoeia Commission and standardizing the pharmacopoeia compiling work procedures, it escorted the quality of the compendial compiling work. The National Pharmacopoeia Commission has vigorously promoted pharmaceutical standards to improve scientific research and ensure the progress and quality of compiling the Pharmacopoeia. Strictly implement the "Chinese Pharmacopoeia Compilation Work Procedures", improve communication and coordination between professional committees, strengthen standards review and publicity work, all standard additions and amendments are published on the National Pharmacopoeia Committee website, and the feedback of expert review results is published to the outside world .
This edition of the Pharmacopoeia, while maintaining the scientific, advanced and normative nature of the Pharmacopoeia, focuses on strengthening the control requirements for the safety and effectiveness of medicines, fully drawing on internationally advanced quality control technologies and experience, and overall improving the level of this edition of the Pharmacopoeia. It reflects the current status of China's current pharmaceutical development and testing technology, and will promote the improvement of China's pharmaceutical quality, accelerate the technological progress of enterprises and product upgrades, promote the healthy development of China's pharmaceutical industry, and enhance the authority and international influence of the Chinese Pharmacopoeia. Continue to play an important role. ^[1]

(BP) Pharmacopoeia British Pharmacopoeia (BP)

Since the first edition in 1864, it has reached the 14th edition. The current edition is the 1988 edition. The Pharmacopoeia has been changed to two volumes since the 1980 edition. The first volume contains the introduction, general principles and raw materials, and infrared comparison maps; the second volume contains various pharmaceutical preparations, blood products, immunological products, radiopharmaceuticals, surgical supplies, appendices and indexes. The 1988 edition contained 2,100 different types of medicines, of which 495 were listed in the European Pharmacopoeia.

The British Pharmacopoeia 2011

The British Pharmacopoeia (BP) is the official collection of standards for UK medicinal products and pharmaceutical substances. Produced by the British Pharmacopoeia Commission Secretariat of the Medicines and Healthcare products Regulatory Agency, the BP makes a valuable contribution to public health by setting publicly available standards for the quality of medicines.

The British Pharmacopoeia 2011 contains

Monographs including British Pharmacopoeia (Veterinary) monographs

Test methods Infrared reference spectra

Supplementary information

European Pharmacopoeia monographs are clearly distinguished and cross-referenced

A full index ensures easy access to the current legally-binding UK standards.

(USP) Pharmacopeia United States Pharmacopeia (USP)

Founded in 1820, it has reached the 22nd edition so far. The current edition is the 1990 edition. The Pharmacopoeia has been merged with the National Pharmacopoeia (NF) since the 1980 edition. USP contains raw medicines and their preparations, while NF contains various excipients and some over-the-counter medicines. According to the United States Pharmacopeia Commission Resolution No. 3 of 1975, all drugs that have been approved for placing on the market should be included in the Pharmacopoeia. The current edition of the United States Pharmacopoeia (USP XXII-NF XVIII) contains 3204 kinds of various medicines, which is currently the largest pharmacopoeia in the world.

The Japanese Bureau of Commerce (JP) has been issued to the 16th edition since the early 1886 edition. The current edition is the 16th revised edition issued in February 2014. This edition of the Pharmacopoeia contains 1221 kinds of medicines, of which 166 are crude drugs. It is one of the many pharmacopoeia containing various types of crude drugs except the Chinese Pharmacopoeia.

(Ph. Int) Pharmacopoeia (Ph. Int)

Prepared by the United Nations World Health Organization. The first edition was published in English, French, and Spanish in two volumes in 1951 and 1955, and a supplement was published in 1959. The second edition was published in English, French, Russian and Spanish in 1967. The current edition is the third edition. It was published in five volumes in 1979, 1981, 1988, 1994, and 2003. The first volume contains 42 analytical test methods. Volumes 2 and 3 contained 383 kinds of medicines. Volume 4 contains information on tests and methods, as well as general requirements and quality specifications for pharmaceutical raw materials, excipients, and dosage forms. Volume 5 contains general guidelines for formulations and quality standards for pharmaceutical raw materials and tablets, which will cover virtually all monographs on the catalog of organic synthetic drugs as well as some antimalarial drugs and their most widely used dosage forms.

(Ph.Eur) Pharmacopoeia European Pharmacopoeia (Ph.Eur)

In 1963, the countries of the European Community agreed to compile the "European Pharmacopoeia". The first edition was published in 1969, and it was published in three volumes. The French and English versions were legal versions. The second edition began in 1980 and was published in successive installments. As of June 1990, it has been published in the 14th volume. This edition contains a total of 704 medicines.