What Are the Different Types of Immunoglobulin Therapy?

Human immunoglobulins are fresh plasma from healthy blood donors or frozen plasma with a shelf life of no more than 2 years. Each batch should be mixed with at least 1,000 healthy blood donors. The immunoglobulin components are extracted by fractional precipitation using a low-temperature ethanol protein separation method, and are obtained through the steps of ultrafiltration or freeze-drying, dealcoholization, concentration, and virus inactivation. The purity of the immunoglobulin should be not less than 90%. Then prepare a solution with a protein concentration of 10%, add an appropriate amount of stabilizer, sterilize and filter, and make it with aseptic filling.

Foreign name: Human Immunoglobulin
Dosage form: injection
Drug type: Biological Products
Specifications: 300mg (10%, 3ml) / bottle
Pinyin name: Ren Mianyi Qiudanbai
Used name: Human blood gamma globulin

main ingredient: Human immunoglobulin
Character: Colorless or yellow clear liquid with opalescence
Storage: 2 ~ 8 ° C, protected from light
Specifications: The concentration is 100g / L (10%), each 300mg
Package: Glass bottle, 300mg / bottle × 1 bottle / box
Expiration date: 3 years

Introduction to human immunoglobulin

Human immunoglobulin Book number introduction:

2000 edition two-1092

This strain is made from healthy human plasma, separated and purified by low-temperature ethanol protein separation method or other approved separation methods, and processed by virus removal and inactivation. Contains suitable stabilizers, without preservatives and antibiotics. ^[1]

Human immunoglobulin component

The active ingredient of this product is human immunoglobulin, and the auxiliary materials are glucose, polysorbate 80, sodium chloride, glycine, and water for injection.

Human immunoglobulin traits

[Character] This product is colorless or light yellow clear liquid, it can be opalescent, and there should be no foreign matter, turbidity or unshakable precipitation.

Clinical application of human immunoglobulin

Human immunoglobulin indication

It is mainly used to prevent measles and infectious hepatitis. If used in combination with antibiotics, it can improve the effect on some serious bacterial and viral infections.

Human immunoglobulin usage and dosage

Usage: Only for intramuscular injection, not for intravenous infusion.

Human immunoglobulin (3 photos)

Dosage:

1. Prevent measles: In order to prevent the onset or reduce symptoms, you can inject 0.05 to 0.15 ml per kg of body weight within 7 days of contact with measles patients, 1.5 to 3.0 ml for children under 5 years old, and the maximum injection amount for children over 6 years old does not exceed 6 ml . The effect of a single injection is usually 2 to 4 weeks.

2. Prevention of infectious hepatitis: 0.05 to 0.1 ml per kg of body weight or 3 ml per injection for adults and 1.5 to 3 ml per injection for children. The preventive effect of one injection is usually about one month.

Human immunoglobulin medication instructions

Human immunoglobulin adverse reactions

Generally, there are no adverse reactions, and a few people will experience redness, swelling and pain at the injection site, and they can recover on their own without special treatment.

Human immunoglobulin taboo

1. Those who are allergic to immunoglobulin or have other severe allergies.

2. Selective IgA deficiency with IgA antibodies.

Human immunoglobulin considerations

1. This product appears turbid, has unshakable precipitation, foreign bodies or cracks in glass bottles, expired, and can not be used.

2. After opening the bottle, the injection should be completed in one time.

3. Freezing is strictly prohibited during transportation and storage.

Fever, local pain due to injection. Blood group diagnosis and more accurate agglutination tests should be performed before use.

Human immunoglobulin for pregnant and lactating women

still not clear.

Human immunoglobulin drug interactions

Should be used alone.

Human immunoglobulin pharmacology and pharmacology

Human immunoglobulin pharmacological effects

Immunoglobulin injection is a passive immunotherapy. It is to transfer a large amount of antibodies contained in the immunoglobulin to the recipient, so that it can reach a temporary immune protection state from a low or no immune state. The antibodies interact with the antigens to directly neutralize toxins and kill bacteria and viruses. Therefore, immunoglobulin products have a certain effect on preventing bacterial and viral infections.

Human immunoglobulin pharmacokinetics

The biological half-life of human immunoglobulin is 16 to 24 days.

Human immunoglobulin price

The price of human immunoglobulin varies with the manufacturer, packaging specifications, and specific sales regions. Generally, the price of 5g specifications is about 500-600 yuan.

Human immunoglobulin storage

In addition, it should be noted that the storage conditions of human immunoglobulins are relatively high. Usually it is stored at 2-8 ° C in the dark, and the efficacy will be greatly reduced after 30 minutes at room temperature. Therefore, it is recommended that everyone inoculate as soon as possible after purchasing the medicine.

^[2]

Human immunoglobulin identification

[Identification] Take this product and follow the "Chinese Biological Product Regulations".

(1) As determined by the immunodiffusion method, only a precipitation line is produced with anti-human serum, and no precipitation line is produced with anti-horse and anti-bovine serum.

(2) As determined by immunoelectrophoresis, the main precipitation line should be immunoglobulin.

Human immunoglobulin test

Check the following items according to the method stipulated in the "Chinese Biological Products Regulations".

The pH should be 6.4 to 7.4.

Sugar content, such as glucose or maltose, must not exceed 5.0%.

The protein is not less than 95% of the labeled amount.

The purity of immunoglobulin should not be less than 90.0% of the total protein.

The sum of the immunoglobulin G monomer and dimer should not be less than 90.0%.

Take this product for thermal stability. After holding in the water bath at 57 ± 0.5 for 4 hours, no gelation or flocculation should occur.

HCV antibodies should be tested with a nationally approved kit and should be negative.

HIV <[1 + 2]> antibodies should be tested negative with nationally approved kits and should be negative.

Take this product for abnormal toxicity, check it according to law, and meet the requirements.

Take this product on pyrogen, inject 0.15g of immunoglobulin per 1kg of rabbit body weight, check according to law, and it should meet the requirements.

Take this product aseptically and inspect it according to law, and it should meet the requirements.

Human immunoglobulin titer determination

Take this product and determine the hepatitis B surface antibody by radioimmunoassay according to the "Chinese Biological Products Regulations". Each 1g protein contains hepatitis B surface antibody not less than 6.0 international units. Separately take this product and determine diphtheria antibodies by passive hemagglutination method according to the "Chinese Biological Products Regulations". Each 1g protein contains no less than 2.0 hemagglutination units.

Human immunoglobulin category

Blood products.

Human immunoglobulins should be paid attention to during the use of human immunoglobulins

Human immunoglobulin has been used by some people as a disease-prevention, physique-enhancing, harmless and beneficial nutrient, but medical experts remind that human immunoglobulin is a blood product made from human plasma and has a higher risk. Patients should be reasonably used under the guidance of a doctor, and doctors should also evaluate the risks and benefits according to the indications, and use such drugs carefully. Human immunoglobulin use has strict indications. Introduced in the "Human Immunoglobulin and Safe Use Related Knowledge" issued by the Food Safety Supervision Department of the State Food and Drug Administration in January 2007. Human immunoglobulin is divided into intramuscular injection and intravenous injection. Two types of intravenous human immunoglobulins are mainly used to treat primary immunoglobulin deficiency, secondary immunoglobulin deficiency and autoimmune diseases. In the Beijing Basic Medical Insurance Drug Catalog, the scope of reimbursement for immunoglobulin products is also strictly defined: rescue of severe infections, severe autoimmune diseases, and it is limited to use by hospitals at level 2 or higher.

Professor Shao Rongguang, deputy director of the Institute of Medicine and Biotechnology, Chinese Academy of Medical Sciences, said that in clinical, human immunoglobulin injection is often used for tumor treatment. Because anti-tumor drugs sometimes have an adverse effect on the body, human immunoglobulins can improve immunity and resist this effect. Its role is only to improve the body's immunity and play an auxiliary role in treatment. If the body's own immunity is sufficient to withstand the invasion of antigens, externally injected antibodies (such as human immunoglobulins, etc.) may reduce the response capacity of the body's immune system. A biologics expert, who asked not to be named, said that human immunoglobulin is a passively injected antibody that works quickly, so it is often used in emergency treatments for rabies, hepatitis B and tetanus, but this antibody can only be present in the human body 3 to 4 weeks. Although human immunoglobulin can improve human immunity, it is a high-risk product. Due to the "window period", such products are at risk of transmitting menstrual infectious diseases such as AIDS, hepatitis B, and hepatitis C. Therefore, the expert suggested that human immunoglobulin must be used with caution.

The improvement of standards can not be avoided. "In the window period, Professor Shao Rongguang believes that the most important thing is that drugs are safe and effective. For blood products, safety is particularly important. China's blood product production and testing standards are relatively complete. Manufacturers must follow the specifications. Production. He especially emphasized that blood is collected from different people, so the testing process in the production process can not be saved in one step.

Are raw materials collected and produced in full compliance with regulations, will blood products be safe? Jia Jidong, chairman of the Liver Diseases Branch of the Chinese Medical Association and director of the Liver Diseases Center of Beijing Friendship Hospital affiliated to Capital Medical University, said that despite strict screening and inspection of raw material plasma, the current international and domestic testing methods have not completely solved the raw material plasma pathogen serum. Although the "window period" problem exists in the scientific detection, although the strict virus inactivation treatment has been performed in the production process, the possibility of transmitting known or unknown pathogenic factors cannot be completely ruled out. According to reports, the "window period" refers to the period from when the virus enters the human body to when a sufficient amount is produced in the blood, and the virus antibody can be detected by detection methods. During this period, even if the patient has been infected with the virus, because the antibody against the virus is not stable, the test result of the virus antibody is negative and it is easy to miss the diagnosis. According to experts, the length of the "window period" is related to the sensitivity of the detection reagent. From the technical level at home and abroad, the problem of the "window period" cannot be avoided.