Antithrombin activity assay method of injection for promoting blood circulation to remove blood stasis

A technology for antithrombin and activity determination, which is applied in the direction of material analysis by observing the influence of chemical indicators, and analysis by making materials undergo chemical reactions, which can solve the problems of lack of biological quality control methods and achieve determination The result is a stable effect

Inactive Publication Date: 2014-02-19
MUDANJIANG YOUBO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the implementation standard of Shuxuetong Injection is the National Drug Standard WS of the State Food and Drug Administrati

Method used

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  • Antithrombin activity assay method of injection for promoting blood circulation to remove blood stasis
  • Antithrombin activity assay method of injection for promoting blood circulation to remove blood stasis
  • Antithrombin activity assay method of injection for promoting blood circulation to remove blood stasis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Example 1 Establishment of Shuxuetong Injection Antithrombin Activity Determination Method

[0019] 1. Test sample preparation

[0020] Take 50ml (batch number: 12040312) of Shuxuetong Injection, concentrate under reduced pressure (50-60°C) to dryness, dissolve the residue with water and transfer it completely to a 5ml measuring bottle, add water to the mark, shake well, then the concentration of the concentrated liquid is 10ml stock solution·ml -1 ; Mix the concentrated medicinal solution with pure water in a corresponding proportion to prepare 10 concentration-gradient Shuxuetong medicinal solutions as test sample solutions, which are sequentially numbered No. 1 to No. 10.

[0021] 2. Linear relationship inspection

[0022] Take a white porcelain plate, wash it and blow dry it, then place it in a water bath (37°C±0.5°C) to preheat, the liquid level is slightly lower than the white porcelain plate. Accurately measure 100 μl of test sample solutions of different conc...

Embodiment 220

[0052] Example 220 Determination of Antithrombin Activity of Shuxuetong Injection

[0053] Accurately measure 6.0ml each of 20 batches of Shuxuetong injection samples, concentrate under reduced pressure (50-60°C) to dryness, dissolve the residue in water and transfer it completely to a 2ml measuring bottle, add water to the mark, shake well, and prepare The concentration is 3.0ml stock solution·ml -1 100 μ l of the need testing solution is precisely measured, put it in a suitable white porcelain plate, add 200 μ l of tris hydrochloride buffer solution (pre-use preparation) containing 0.5% (bovine) fibrinogen, and stir Put it in a water bath (37°C±0.5°C) and warm it for 5min, add dropwise the thrombin solution containing 10 units per 1ml (drop once every 1min, 5μl each time, stir gently while adding dropwise, every minute Stir about 10 times) until a whole piece can stir up a transparent gel-like precipitate, record the volume of the consumed thrombin solution, record the titr...

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Abstract

The invention provides an antithrombin activity assay method of an injection for promoting blood circulation to remove blood stasis. The antithrombin activity assay method is characterized in that a ceramic whiteware spot plate is taken as a reaction carrier; thrombin titration interval time, thrombin concentration and stirring frequency of a tool pin are controlled to ensure that the determination results are stable. The antithrombin activity assay method provides a biological quality control method for the injection for promoting blood circulation to remove blood stasis, and facilitates evaluation to reliability and controllability of the quality.

Description

technical field [0001] The invention relates to a method for measuring antithrombin activity of Shuxuetong injection, which belongs to the field of pharmaceutical technology. Background technique [0002] Shuxuetong Injection is a traditional Chinese medicine injection made from leeches and earthworms. It promotes blood circulation and removes blood stasis, clears meridians and activates collaterals; it is used for the acute stage of meridians in stroke caused by blood stasis. The symptoms include hemiplegia, crooked tongue, speech Jian astringent; patients with acute cerebral infarction see the above syndromes; it has antithrombotic, thrombolytic, and blood circulation improving effects. Authorized announcement number CN1192782C, announcement date March 16, 2005, invention patent titled "Manufacturing method and product of injection for treating cardiovascular and cerebrovascular diseases" discloses the traditional Chinese medicine injection and its preparation method. [...

Claims

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Application Information

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IPC IPC(8): G01N21/83
CPCG01N21/83
Inventor 李振国陈艳明郑顺亮倪开岭
Owner MUDANJIANG YOUBO PHARMA CO LTD
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