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Biological quality control method of Shuxuetong injection

A quality control method and injection technology, applied in the direction of color/spectral characteristic measurement, etc., can solve the problems of accuracy of measurement results, susceptibility to blood properties, complicated operation, etc., to improve quality controllability and overcome human differences , the effect of simple process

Inactive Publication Date: 2014-02-26
MUDANJIANG YOUBO PHARMA CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the thrombin titration method (visual method) has different standards for judging the coagulation end point by the human eye, and there are certain artificial differences, which will affect the accuracy of the measurement results; and the APTT kit and PT kit methods are expensive. , Complicated operation, easily affected by blood properties

Method used

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  • Biological quality control method of Shuxuetong injection
  • Biological quality control method of Shuxuetong injection
  • Biological quality control method of Shuxuetong injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Example 1 Establishment of biological quality control method for Shuxuetong injection

[0026] 1. Preparation of solution

[0027] Preparation of thrombin solution: take the standard thrombin, and use normal saline as the solvent to prepare 2.0, 4.0, 8.0, 12.0, 16.0 U / ml thrombin solution (prepared for immediate use).

[0028] The preparation of fibrinogen solution: take the fibrinogen standard and use normal saline as the solvent to prepare fibrinogen solution of 0.10, 0.25, 0.50, 0.75, 1.00 mg / ml (prepared for immediate use).

[0029] 2. Selection of concentration of fibrinogen solution

[0030] Take 5 test tubes with an inner diameter of 1 cm and a length of 10 cm, add 900 μl each of the prepared fibrinogen solution of 0.10, 0.25, 0.50, 0.75, and 1.00 mg / ml, and place them in a 37°C water bath for 3 minutes. Add 100μl of thrombin solution with a concentration of 12U / ml to 5 test tubes respectively, keep time at the same time, shake well, place in a water bath, observe (visual...

Embodiment 210

[0074] Example 210 Determination of Shuxuetong Injection

[0075] Using the established biological quality control method, 10 batches of Shuxuetong injection samples were measured by ultraviolet method; and compared with the antithrombin activity data measured by thrombin titration method (modified method). It can be seen that there is a good relationship between the average initial clotting time measured by the newly established biological quality control method (UV method) of Shuxuetong injection and the anticoagulant activity data measured by the thrombin titration method (modified method). Positive correlation, that is, the method can reflect (evaluate) the real antithrombin activity of Shuxuetong injection samples.

[0076] Table 6 Determination of initial clotting time (UV method) of 10 batches of Shuxuetong injection and comparison with thrombin titration method (modified method)

[0077]

[0078] The examples illustrate that the biological quality control method of Shuxueton...

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Abstract

The invention provides a biological quality control method of a Shuxuetong injection. The biological quality control method is characterized in that a method for rapidly evaluating the antithrombin activity of the Shuxuetong injection in vitro is established by utilizing a fibrinogen and thrombin model through an ultraviolet method. The disadvantages of having personal error in titration end-point judgment, being high in cost of an APTT (Activated Partial Thromboplastin Time) kit and PT (Prothrombin Time) kit method, complex for operation, easily influenced by blood nature and the like in the existing antithrombin activity evaluating and measuring method through the thrombin titrimetric method (appearance method) are overcome. The biological quality control method disclosed by the invention has the advantages of being rapid, simple and convenient for operation, high in sensitivity and good in repeatability; the reliable and rapid biological quality control method is provided for the Shuxuetong injection; the biological quality control method disclosed by the invention is beneficial to increasing the quality controllability of products and ensuring the clinical curative effect of the products.

Description

Technical field [0001] The invention relates to a biological quality control method of Shuxuetong injection, which utilizes fibrinogen and thrombin models and uses ultraviolet method to establish an in vitro method for quickly evaluating the antithrombin activity of Shuxuetong injection, belonging to medicines The field of technology. Background technique [0002] Shuxuetong injection is a traditional Chinese medicine injection made of leeches and earthworms. It promotes blood circulation, removes blood stasis, and clears the meridians and collaterals. It is used in the acute phase of apoplexy caused by blood stasis and obstruction of the collaterals. The symptoms are hemiplegia, crooked tongue and speech. Astringent; acute cerebral infarction sees the above-mentioned syndromes; has antithrombotic, thrombolytic, and improved blood circulation effects. Authorized announcement number CN1192782C, announcement date March 16, 2005, the invention patent titled "Manufacturing method an...

Claims

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Application Information

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IPC IPC(8): G01N21/33
Inventor 李振国陈艳明郑顺亮倪开岭
Owner MUDANJIANG YOUBO PHARMA CO LTD
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