High-titer hepatitis B immunized plasma and preparing process thereof

A preparation process and high titer technology, applied in the direction of antiviral agents, antibodies, etc., can solve the problems of low titer and backwardness of immune plasma antibodies, and achieve the effect of simple preparation process and strong operability

Inactive Publication Date: 2012-07-18
HUNAN KANGRUN PHARMA
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Problems solved by technology

However, the traditional method of preparing hepatitis B immune plasma is relatively backward, and the antibody titer of the prepared immune plasma is not high

Method used

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Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0014] Embodiments of the present invention are as follows:

[0015] 1. Grouping: Divide blood donors with HBsAb10ml U / ml into two groups, and each group is immunized according to different immunization procedures and doses;

[0016] 2. Plasma collection method of raw material: collection by automatic plasma collection machine;

[0017] 3. Detection method: use ELISA, operate according to the instructions of the HBsAb kit, draw a standard curve in the range of 0-160mlU / ml, and do 20 and 40mlU / ml standard quality control at the same time. Samples that exceed the range of the standard curve are diluted 1:100 times, and the results are multiplied by 100 when testing again;

[0018] 4. Judgment criteria: if the test result is HBsAb>10mIU / ml, it is antibody seroconversion; if the plasma with HBsAb>8IU / ml is high-efficiency HBsAb plasma.

[0019] Analysis of the results: After HBsAb-negative blood donors have been immunized with hepatitis B vaccine (10ug or 20ug), it is difficult ...

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Abstract

The invention relates to high-titer hepatitis B immunized plasma and a preparing process of the immunized plasma. The titer of a hepatitis B antibody is more than 8IU / ml. The preparing process comprises the following steps of: (1) grouping: dividing blood donors with HBsAb (hepatitis B surface antibody) less than 10mIU / ml and more than 10mIU / ml into two groups, and immunizing each group according to different immunizing procedures and different immunizing doses; (2) raw material plasma collecting manner: collecting by adopting a full-automatic plasma collector; (3) detection method: performing operation according to the specification of an HBsAb kit by adopting ELISA (enzyme-linked immunosorbent assay); and (4) judgment standard: judging the detection result HBsAb more than 10mIU / ml to be antibody positive conversion and the plasma with HBsAb more than 8IU / mL to be high-titer HBsAb plasma. According to the invention, the titer of the hepatitis B antibody in the high-titer hepatitis B immunized plasma is more than 8IU / ml; and the preparing process is simple and strong in operability.

Description

technical field [0001] The invention relates to a biological product raw material and its preparation process, in particular to a high-titer hepatitis B immune plasma and its preparation process. Background technique [0002] Human hepatitis B immunoglobulin is prepared from high titer HBsAb plasma collected from blood donors after being immunized with hepatitis B vaccine, and is mainly used for the prevention of hepatitis B. In order to obtain high-titer HBsAb immune plasma, the department immunizes healthy blood donors with different immunization doses of vaccines and different immunization procedures, and detects their antibody levels. The plasma that meets the antibody titer standard is used to prepare human hepatitis B immunoglobulin . However, the traditional method for preparing hepatitis B immune plasma is relatively backward, and the antibody titer of the prepared immune plasma is not high. Contents of the invention [0003] The purpose of the present invention ...

Claims

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Application Information

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IPC IPC(8): A61K39/42A61P31/20
Inventor 毛金武柳克华周咏武
Owner HUNAN KANGRUN PHARMA
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