Each batch should be mixed with the plasma of at least 100 immune blood donors, and the titer of hepatitis B surface antibody in the mixed plasma should be not less than 8 international units/1ml. Immunoglobulin components are extracted by fractional precipitation with low-temperature ethanol protein separation method, and are prepared by ultrafiltration or freeze-drying, dealcoholization, concentration and virus inactivation. The purity of immunoglobulin should be greater than 90%. And then preparing a solution with the titer of hepatitis B antibody not lower than 100 international unit/1 ml.
As for the effect, it does not depend on which hospital is injected, but which manufacturer's products are injected. At present, all hepatitis B immunoglobulins have to pass the national compulsory inspection before they can be listed, but there will still be great differences.
It is recommended to use hepatitis B immunoglobulin produced by Shanghai Xinxing Pharmaceutical Co., Ltd..
Shanghai Xinxing Pharmaceutical Co., Ltd. is a national designated manufacturer of blood products and a high-tech export-oriented pharmaceutical company integrating drug production, management and scientific research and development. The company is a key high-tech enterprise in the national torch plan, a high-tech enterprise in Shanghai, a third-class enterprise in science and technology industrialization in Shanghai, and an excellent industrial enterprise in Shanghai. The company has a postdoctoral research center, a GMP certificate issued by SFDA in China, a first-class blood product factory in Asia, a group of high-level R&D teams and a pharmaceutical sales network all over the country. The company's main products are human albumin, intravenous human immunoglobulin, human prothrombin complex, human coagulation factor VIII, rabies human immunoglobulin, hepatitis B human immunoglobulin, tetanus human immunoglobulin, human fibrinogen and human fibrin adhesive, and it is the enterprise with the largest number of production approvals in China.
The company produces hepatitis B immunoglobulin in three specifications: 100IU, 200IU and 400IU. Is one of the few domestic enterprises that can produce three specifications. Its production technology is advanced and its quality is leading. It is the first-line brand of this product in China and has a high recognition among hospitals and patients.