Preparation process of antitoxic serum for viral inactivation treatment

A technology for virus inactivation and serum preparation, which is applied in the direction of antiviral agents, antiviral agents, antiviral immunoglobulins, etc., can solve problems such as the lack of corresponding removal of viruses and the safety of antitoxin serum products, and achieve complete inactivation and easy The effect of the operation

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 prepared stock solution is derived from animal plasma (serum) raw materials, and animal raw materials may contain viruses of zoonotic infectious diseases, but all steps in the current process have not correspondingly removed viruses Therefore, there are serious safety problems in the application of antitoxin serum products

Method used

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Embodiment Construction

[0021] A virus inactivation treatment antitoxin serum preparation process, comprising the following steps:

[0022] 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;

[0023] 2. For the first precipitation and heating denaturation treatment, after digestion, add 10-20g of ammonium sulfate per 100ml of digestion solution, adjust the pH to 4.50-6.50, heat to 60±1°C, keep warm for 10 hours, and keep warm , lower the temperature to below 45°C, add 0.5-0.8g of diatomaceous earth to 100ml of the digestion solution, stir evenly, pump the digestion solution into a plate and frame filter press for filtration and separation, collect the supernatant by filtration, ...

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Abstract

A preparation process of antitoxic serum for viral inactivation treatment comprises the steps of pepsin digestion, first precipitation and heating degeneration treatment, second precipitation treatment, alum precipitation treatment, ultrafiltration concentration treatment, and stock solution preparation. Two viral inactivation methods are utilized in the steps and can be respectively and independently implemented or implemented in a combined mode to enable an antitoxic serum product to be safe and inactivation to be complete. Furthermore, the two viral inactivation methods are physical methods, are free of addition of other matters, do not bring about other practical problems to preparation of antitoxic serum stock solution do not happen, and have no special requirements for plants, facilities and personnel, thereby being convenient and easy to operate.

Description

technical field [0001] The invention relates to a preparation process of antitoxin serum treated with virus inactivation. 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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395C07K16/06C07K16/12C07K16/10C07K16/18A61P31/04A61P31/14A61P39/02
Inventor 姚晓东季冲邓大义敬伟
Owner JIANGXI INST OF BIOLOGICAL PRODS
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