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Protective agent of human antithrombin preparation in freezing and drying process

A technology of anti-thrombin and drying process, which is applied in the field of medicine and biology, can solve problems such as protein denaturation, achieve the effects of protecting activity, increasing yield, and reducing the loss of anti-thrombin activity

Active Publication Date: 2013-03-20
GUIZHOU TAIBANG BIOLOGICAL PROD
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  • Abstract
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Problems solved by technology

[0004] The purpose of the present invention is to facilitate the preservation and transportation of human antithrombin preparations, and to improve the freeze-drying process of human antithrombin preparations in the prior art, Provides a protective agent for antithrombin preparations during freeze-drying of human antithrombin preparations due to problems that directly or indirectly cause protein denaturation

Method used

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  • Protective agent of human antithrombin preparation in freezing and drying process
  • Protective agent of human antithrombin preparation in freezing and drying process
  • Protective agent of human antithrombin preparation in freezing and drying process

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Embodiment Construction

[0012] Below in conjunction with embodiment and accompanying drawing, the effect of protective agent of the present invention in the freeze-drying process of antithrombin preparation is described in detail,

[0013] 1. Antithrombin Extraction

[0014] Precipitation of component IV of blood products by Cohn’s method, extraction of sodium citrate and NaCl solution at 25°C for 60 minutes, centrifugation of the extract at 6000rmp for 40 minutes, and supernatant; supernatant was filtered with 0.80 μm and 0.45 μm membranes, and the filtrate was passed through a pro- and chromatography to obtain the eluate, which was desalted by ultrafiltration and concentrated to obtain antithrombin concentrate (≥6.0IU / mg).

[0015] 2. Add lyoprotectant to prepare antithrombin lyophilized preparation

[0016] Under the condition of 25-37 ℃, use deionized water, according to the mass percentage, prepare the concentration of 4-16% sucrose, or lysine hydrochloride, or tyrosine, or aspartic acid soluti...

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Abstract

The invention discloses a protective agent of human antithrombin preparation in freezing and drying process. According to the protective agent, a protective agent solution is prepared from one of solute sucrose, amino acid or salt of the amino acid by using deionized water, wherein the amino acid is lysine or hydrochloride in the salt of the lysine, or tyrosine or one of the salts in the tyrosine, or aspartic acid or one of the salts in the aspartic acid; one of the solutes is prepared into a solution by using deionized water so as to obtain the protective agent; the protective agent is added before the human antithrombin preparation is frozen and dried, the inactivation of the main antithrombin ingredient in the preparation in the freezing and drying process is effectively prevented, the activity of the antithrombin is protected, and the antithrombin has better forming appearance and redissolving clarity of the preparation after being frozen and dried.

Description

technical field [0001] The invention relates to the technical field of medicine and biology, and relates to the freeze-drying process of human antithrombin preparations, which can effectively prevent the inactivation of the antithrombin main component in the preparations. Specifically, adding sucrose or amino acids or their salts to the antithrombin preparation can effectively protect the antithrombin activity during the freeze-drying process (-40°C to 30°C) and increase the yield of the antithrombin preparation . Background technique [0002] Human antithrombin (antithrombin, AT) is a single-chain alpha 2 Glycoprotein, mainly synthesized in the liver, consists of 423 amino acids, with a relative molecular weight of about 58.2kD (kilodaltons), and a normal plasma content of about 150mg / l. Antithrombin can inhibit the activity of thrombin and activated coagulation factors Ⅸ, Ⅹ, Ⅺ, and Ⅻ, accounting for 70-85% of the plasma anticoagulant activity. In addition, it also has ef...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/26A61K47/18A61K38/43A61P7/02
Inventor 叶生亮曹海军胡吉军袁靖李长清陈云华刘欣晏杨刚
Owner GUIZHOU TAIBANG BIOLOGICAL PROD
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