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Method for determining antithrombin activity of Shuxuetong injection

An antithrombin, activity measurement technology, applied in material analysis by observing the effect of chemical indicators, and analysis by chemical reaction of materials, etc., can solve problems such as lack of biological quality control methods

Inactive Publication Date: 2016-06-01
MUDANJIANG YOUBO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, the implementation standard of Shuxuetong Injection is the National Drug Standard WS of the State Food and Drug Administration. 3 -548(Z-084)-2005(Z), but this standard only measures and controls the chemical composition, and lacks biological quality control methods

Method used

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  • Method for determining antithrombin activity of Shuxuetong injection
  • Method for determining antithrombin activity of Shuxuetong injection
  • Method for determining antithrombin activity of Shuxuetong injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Example 1 Establishment of Shuxuetong Injection Antithrombin Activity Determination Method

[0020] 1. Test sample preparation

[0021] 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.

[0022] 2. Linear relationship inspection

[0023] 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

[0053] Example 220 Determination of Antithrombin Activity of Shuxuetong Injection

[0054] 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 a method for determining the antithrombin activity of a Shuxuetong injection. The method is characterized in that a white porcelain spot plate is adopted as a reaction carrier, and the thrombin titration interval time, thrombin concentration and the stirring frequency of a stirring needle are controlled to ensure the stability of a determination result. The method is a biological quality control method for the Shuxuetong injection and facilitates the assessment on the quality reliability and controllability of the Shuxuetong injection.

Description

[0001] This application is a divisional application for the invention patent with the patent number 201310596718.7. The filing date of the original application is November 25, 2013, the application number is 201310596718.7, and the name of the invention is a method for measuring antithrombin activity of Shuxuetong injection. technical field [0002] The invention relates to a method for measuring antithrombin activity of Shuxuetong injection, which belongs to the field of pharmaceutical technology. Background technique [0003] 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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
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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