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Intravenous injection employ persons hepatitis B immune globulin and method of preparing the same

A technology of immunoglobulin and hepatitis B, which is applied in the direction of antiviral immunoglobulin, immunoglobulin from serum, peptide preparation methods, etc., can solve the problems of unsuitable scale production, complex process, expensive price, etc., and meet the supply of plasma , improve the survival rate, and overcome the bottleneck of process amplification

Active Publication Date: 2008-08-27
广东双林生物制药有限公司
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AI Technical Summary

Problems solved by technology

[0005] The current preparation of human hepatitis B immunoglobulin for intravenous injection is complicated and requires special equipment, which is not suitable for large-scale production, so the price is expensive

Method used

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  • Intravenous injection employ persons hepatitis B immune globulin and method of preparing the same

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Embodiment Construction

[0023] The present invention will be further described through specific examples below, but the present invention is not limited to this specific example.

[0024] 1. Preparation of human hepatitis B immunoglobulin raw material plasma for intravenous injection

[0025] Select plasma donors who meet the national apheresis plasma donation standards, use 3 needles for one tube each time, and the content of hepatitis B vaccine is 10 mg per tube, and give plasma donors injections of hepatitis B vaccine for basic immunization in 0, 1, and 6 months. Plasma donors who are positive for hepatitis B surface antibody after basic immunization will be injected with hepatitis B vaccine for booster immunization 6 months after the completion of basic immunization. After 14 days of booster immunization, plasma from healthy people with a titer of hepatitis B antibody greater than 8IU / ml will be collected. The plasma collection process is in accordance with the Ministry of Health "Technical Requi...

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Abstract

The invention discloses hepatitis B immunoglobulin used in intravenous injection and a preparation method thereof. The hepatitis B immunoglobulin used in intravenous injection comprises a high-titer hepatitis B virus antibody, and the content of the immunoglobulin is not less than 95.0 percent of the total protein content; the titer of the hepatitis B antibody is more than 50IU / ml, and the sum of an IgG monomer and a dimmer is not less than 95 percent; the hepatitis B immunoglobulin is prepared through the multi-step separation, virus inactivation, ultra-filtration and dealcoholization and the filling of the raw plasma. The hepatitis B immunoglobulin used in intravenous injection is an effective drug used for preventing the patients with liver transplantation from being re-infected by the hepatitis B virus, and can obviously reduce the hepatitis B virus infection rate of the patients with liver transplantation and improve the survival rate of the patients; By overcoming the present technical bottleneck and adopting the unique process parameter control, the preparation process can produce immunoglobulin with anti-hepatitis B specificity with a conventional device of cold ethanol precipitation and pressure filtration and separation, and is suitable for scale industrial production. The products have good anti-hepatitis B activity, and are safe and reliable.

Description

technical field [0001] The invention relates to a human hepatitis B immunoglobulin for intravenous injection and a preparation method thereof. Background technique [0002] There are at least 350 million people in the world who carry hepatitis B virus (HBV), and 300 million liver cirrhosis is related to HBV infection. my country is a high-incidence area for HBV infection. The positive rate of hepatitis B surface antigen (HBsAg) in the population is 9.75%. HBsAg carriers 120 million people; among HBV carriers, a quarter will develop chronic liver disease. Based on this calculation, there are no less than 30 million people with chronic hepatitis B liver disease in the country. If these patients are not treated in time, they will further develop into liver disease. The probability of fibrosis, liver cirrhosis and even liver cancer is relatively high, and it can be transmitted to infants and children through mother to child, affecting the health of the next generation and causing ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/42A61K9/08A61K9/19C07K16/06C07K16/08C07K1/14
Inventor 朱光祖吕应年黄荣强蒋桂香郑文东王明明
Owner 广东双林生物制药有限公司
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