A preparing method of high-purity antivenene

A technology for serum preparation and anti-snake venom, applied in the directions of anti-venom, antibodies, medical raw materials derived from mammals, etc., can solve the problems of large allergic side effects, difficult to further improve the purity, and complicated preparation process of snake venom wounds, so as to reduce allergies. Effects of Side Effects Risk

CN107693541AInactive Publication Date: 2018-02-16浙江健博生物科技股份有限公司
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Publication Date
2018-02-16
Estimated Expiration
Not applicable · inactive patent

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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.
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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...

Examples

Embodiment

[0049] Product Name: Antivenom F(ab’) 2 High-purity antivenom preparations with a purity greater than 80%;

[0050] Material:

[0051] Puree: ultra-free horse plasma;

[0052] Diluent: water for injection;

[0053] αpH regulator: dilute hydrochloric acid 1mol / L;

[0054] βpH regulator: sodium hydroxide solution, 1mol / L;

[0055] γpH regulator: disodium hydrogen phosphate solution 0.5mol / L;

[0056] Enzymolysis agent: pepsin, specific activity 1:15000, 10mmmol / L, activated by hydrochloric acid;

[0057] Precipitant: octanoic acid, analytically pure;

[0058] Packing: ion exchange chromatography packing, anion-agarose DEAE-Sepharose;

[0059] Filtration membrane: polyethersulfone membrane 0.45μ;

[0060] Ultrafiltration membrane: polyethersulfone membrane 30kD;

[0061] Sterilization membrane: polyethersulfone film 0.2μ;

[0062] A buffer solution: 50mmol / L phosphate solution + 60mmol / L sodium chloride solution;

[0063] B buffer solution: 50mmol / L phosphate solution ...