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Preparation method of antitoxic serum for octanoic acid purification treatment

A serum preparation and antitoxin technology, applied in the directions of antitoxin, antiviral, antiviral immunoglobulin, etc., can solve the problems of high incidence of allergic reactions and serum sickness, and low content and specific activity of antitoxin serum products. , to achieve the effect of high quality index and reduced incidence

Inactive Publication Date: 2012-07-04
JIANGXI INST OF BIOLOGICAL PRODS
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Problems solved by technology

[0003] The disadvantage of this process is that the content and specific activity (unit / gram protein) of the prepared antitoxin serum product F(ab)2 are low, and the incidence of allergic reactions and serum sickness are relatively high in clinical application

Method used

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Embodiment Construction

[0016] A method for preparing anti-toxin serum through caprylic acid purification, comprising the following steps:

[0017] 1. Digest with pepsin, add 2-4 times the amount of plasma to purified water to dilute the qualified immune plasma, adjust the pH to 2.90-3.50, add 3-10 activity units per ml of diluent according to the total amount of diluent Gastric enzyme, add 0.2% (ml / ml) toluene (or not), control the temperature of the digestive solution at 30±1°C, and digest for 1-1.5 hours;

[0018] 2. The first precipitation and heating denaturation treatment method, after digestion, add 10-20g of ammonium sulfate per 100ml of digestion solution, adjust the pH to 5.20-5.60, heat to 58±1°C, keep warm for 30 minutes, keep warm After completion, lower the temperature to below 45°C, add 0.5-0.8g of diatomaceous earth to 100ml of digestive juice, stir evenly, and pump the digestive juice into a plate and frame filter press for filtration and separation. The supernatant is ...

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Abstract

A preparation method of antitoxic serum for octanoic acid purification treatment comprises steps of pepsin digestion, first precipitation and heating degeneration treatment, second precipitation treatment, alum precipitation treatment, ultrafiltration concentration treatment, and stock solution preparation. An octanoic acid purification step is added in the preparation method, so that an antitoxic serum product has high quality indexes and safe usage. Compared with an existing preparation process, in main quality indexes of the antitoxic serum product, content of F(ab)2 is increased to above 80% from 50%-60%, purity specific activity (unit / g protein) is improved to above 78000 from 35000-45000, and allergic reaction incidence and serum sickness incidence of the antitoxic serum product are reduced by 30%-40% during clinical application.

Description

technical field [0001] The invention relates to a preparation method of antitoxin serum purified by octanoic acid. Background technique [0002] Antitoxin serum, which can be called antitoxin, also known as antiserum, is the immune plasma (serum) obtained from animals (mainly equine animals) immunized with corresponding toxins or toxoids, bacteria, and viruses, digested with pepsin, ammonium sulfate Analyze the prepared immunoglobulin preparation, and its preparation method is the technology disclosed in "China Biological Products Regulations" and "Chinese Pharmacopoeia". At present, the preparation method of antitoxin serum generally includes the following steps: 1. Pepsin digestion, diluting various immune plasma (serum) with purified water or water for injection, and digesting with pepsin to obtain digestive juice; 2. Precipitation for the first time And heat denaturation treatment, add ammonium sulfate to the digestive solution, and adjust the pH value, then heat and ma...

Claims

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Application Information

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IPC IPC(8): A61K39/395C07K16/06C07K16/10C07K16/14C07K16/18A61P31/04A61P31/14A61P39/02
Inventor 季冲姚晓东邓大义敬伟
Owner JIANGXI INST OF BIOLOGICAL PRODS
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