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Quality control method for salvianolic acid injection

A quality control method and technology for total phenolic acid injection, applied in the field of quality control of traditional Chinese medicine, can solve problems such as insufficient comprehensive reflection of the inherent quality of total phenolic acid injection of salvia miltiorrhiza, high difficulty and complex composition of total phenolic acid injection of salvia miltiorrhiza

Active Publication Date: 2010-06-09
TIANJIN TASLY ZHIJIAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the composition of Salvianolic Acid Injection is complicated, and it is not only difficult to measure each single component, but also not enough to fully reflect the internal quality of Salvianolic Acid Injection

Method used

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  • Quality control method for salvianolic acid injection

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] 1 Test samples and reagents

[0021] 1.1 Total phenolic acid of salvia miltiorrhiza for injection, batches 20060601, 20060801, 20061101 of Tianjin Tasly Zhijiao Pharmaceutical Co., Ltd.

[0022] 1.2 Aggregation-inducing agent: 5-adenosine diphosphate disodium salt (ADP): Specification: 0.1 g: bottle, batch number: A2754, produced by SIGMA Corporation of the United States.

[0023] 1.3 Epinephrine hydrochloride: Specification: 1mg / ml / bottle, batch number: 0608181, Tianjin Jinyao Amino Acid Co., Ltd.

[0024] 1.4 Collagen: Specification 1g / bottle, batch number: 124H7060, produced by SIGMA Company of the United States.

[0025] 1. 50.9% Sodium Chloride Injection Specification: 500ml / bottle, batch number: 6180C, produced by China Otsuka Pharmaceutical Co., Ltd.

[0026] 2 instruments

[0027] BS-634 Platelet Aggregator, produced by Beijing Biochemical Instrument Factory.

[0028] 3 animals

[0029] 3.1 Mice, strain: CD-1 (ICR), body weight 26-28 grams, male, SPF grade....

Embodiment 2

[0038] The preparation of embodiment 2 salvia miltiorrhiza total phenolic acid injection

[0039] 1. Raw material preparation

[0040]1000 grams of Danshen decoction pieces, boiled in 6000ml water for three times, 0.5 hours each time. Combine the extracts, filter, adjust the pH value of the filtrate to 3.5 with 10% hydrochloric acid, pass through 1000 grams of AB-8 macroporous resin column, wash with 10000 ml of water, elute with 10000 ml of 50% ethanol, concentrate the eluate to no alcohol, and pass the concentrated solution through 500 gram of polyamide, washed with 12000ml30% ethanol, eluted with 12000ml95% ethanol, concentrated ethanol eluent, and spray-dried. Obtain 28 grams of extract, the content of salvianolic acid B is 59%, and the total phenolic acid of Salvia miltiorrhiza is 83.1%.

[0041] 2. Composition and preparation of preparation prescription

[0042] Salvia Total Phenolic Acid 100g

[0043] Mannitol 100g

[0044] Add water for injection to 2500ml

[004...

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Abstract

The invention discloses a quality control method for salvianolic acid injection, which uses the medicinal effect result of an observed sample as an index, and specifically uses the influence of the observed sample on the aggregation function of platelets in a tested animal as an index. The method of the invention conveniently and effectively realizes quality control on the salvianolic acid injection, integrally characterizes the quality of the salvianolic acid injection, is simple and feasible, and has accurate and reliable results.

Description

technical field [0001] The invention relates to the field of quality control of traditional Chinese medicines, in particular to a quality control method of salvianolic acid injection. Background technique [0002] Salvia miltiorrhiza is the dried rhizome of Salvia miltiorrhiza Bunge, a plant of the Labiatae family. It is one of the earliest and most widely used medicines in traditional medicine in my country. After long-term clinical application and modern medical research, it has a comprehensive understanding of its clinical effects and pharmacological effects know. Traditional Chinese medicine theory believes that Danshen can promote blood circulation and remove blood stasis; regulate menstruation and relieve pain; nourish blood and calm the nerves; cool blood and eliminate carbuncle. ; bruises; heat into the camp blood; restlessness; upset and insomnia; carbuncle sore swelling. Modern pharmacological studies have shown that Salvia miltiorrhiza has the functions of protec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/537A61P9/10G01N33/50
Inventor 岳洪水牛孝亮
Owner TIANJIN TASLY ZHIJIAO PHARMA
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