A preparing method of high-purity antivenene

Abstract

A preparing method of high-purity antivenene is disclosed. The method includes materials and a preparing process. Digestion with pepsase, precipitation separation with n-caprylic acid and purificationwith ion chromatography are adopted. According to a technical scheme, a characteristic that the n-caprylic acid enables precipitation of impurity proteins except immune globulin (IgG) is utilized, precipitation is performed utilizing the n-caprylic acid to remove the impurity proteins, and then purification is performed through ion chromatography to increase purity of antivenene F(ab')2. Throughthe technical scheme, a problem that purity increase is difficult in the prior art and a disadvantage that allergy side effects on patients affected with snake venom are serious are solved, and the objective of increasing purification indexes of the antivenene F(ab')2 and reducing the allergy side effects on patients affected with snake venom is achieved.

Description

technical field [0001] The invention relates to a method for preparing biological preparations, in particular to a method for preparing high-purity antivenom serum. Background technique [0002] Description: Antivenom F(ab') 2 The preparation is a biological agent for the treatment of human venomous snake bites, antivenom F(ab') 2 The purity index of the preparation has a greater impact on the allergic side effects of snake venom patients. The third part of "Chinese Pharmacopoeia" 2015 edition requires antivenom F(ab') 2 The purity index of the preparation is not less than 60%; the anti-toxic antibody is a fragment on the immunoglobulin (IgG); the hyperimmune horse plasma is the plasma preparation prepared from the horse blood collected from the living horse after the snake venom immunization; Snake Venom Serum F(ab') 2 Extracted from ultra-free horse plasma, the immunoglobulin (IgG) in the hyper-free horse plasma contains anti-venom antibodies; [0003] In the prior art...

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Problems solved by technology

[0003] In the prior art, antivenom F(ab') is prepared by adopting ultra-free horse plasma through pepsin digestion, ammonium sulfate purification, and alum adsorption. 2 , the preparation process of this method is complex, and the obtained antivenom F(ab') 2 The purity index is 60~70%, and the purity is difficult to improve further; Therefore, there are problems and deficiencies in the prior art that the purity is difficult to improve, and the allergic side reactions of snake venom patients are large.

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