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

Inactive Publication Date: 2018-02-16
浙江健博生物科技股份有限公司
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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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  • A preparing method of high-purity antivenene
  • A preparing method of high-purity antivenene

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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 ...

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Abstract

The invention discloses a method for preparing high-purity antivenom, including materials and preparation technology. The present invention adopts the preparation process of pepsin digestion, n-octanoic acid precipitation separation and ion chromatography purification, utilizes n-octanoic acid to have the property of causing precipitation to heterogeneous proteins other than immunoglobulin (IgG), and removes heterogeneous impurities by precipitation through n-octanoic acid The protein is purified by ion chromatography to improve the purity of the antivenom F(ab')2, which overcomes the 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. The antivenom F(ab')2 preparation achieves the purpose of improving the purity index and reducing allergic side reactions of snake venom patients.

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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/16A61K39/395A61P39/02
CPCA61K35/16A61K39/395
Inventor 郑颖杨廷潺范泉水
Owner 浙江健博生物科技股份有限公司
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