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

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 ...

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