Method for detecting tannin substance in salvianolic acid used for injection

A technology of salvianolic acid and detection method, applied in the field of medical detection, can solve the problems of complex composition and poor separation effect, and achieve the effect of high sensitivity

Active Publication Date: 2013-10-30
TIANJIN TASLY ZHIJIAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The preparation of salvianolic acid belongs to the prior art. In the preparation process, impurity tannin components may appear according to different processes. At present, the methods for removing tannin from salvianolic acid mainly include gelatin precipitation, alkaline alcohol precipitation and polymerization. Amide adsorption method, etc., but due to the complex components in the salvianolic acid sample, the separation effect is not good, and if the operation is improper, tannins may be introduced

Method used

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  • Method for detecting tannin substance in salvianolic acid used for injection
  • Method for detecting tannin substance in salvianolic acid used for injection
  • Method for detecting tannin substance in salvianolic acid used for injection

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Experimental program
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Effect test

Embodiment 1

[0085] Preparation of salvianolic acid for injection: take a certain amount of salvia miltiorrhiza, add water to decoct three times, combine the decoction, cool, let stand, centrifuge or filter to remove precipitate, pass through polyamide column, and eluate pass through AB-8 type large Pore ​​adsorption resin, eluting with water, discarding the water, eluting with ethanol, recovering ethanol under reduced pressure until there is no alcohol smell, adjusting the pH to near neutral, finally adding mannitol, packaging, and getting ready.

[0086] Detection: Preparation of unhydrolyzed sample solution: Accurately weigh 0.1 g of salvianolic acid, dissolve in 10 ml of 60% acetone, ultrasonicate for 30 min, and filter through a 0.22 um microporous membrane to obtain the product.

[0087] Preparation of hydrolyzed sample solution: Accurately weigh 0.1 g of salvianolic acid, dissolve it in 5 ml of 60% acetone, add 5 ml of 2 mol / L hydrochloric acid solution, and hydrolyze at 100°C for 4 ...

Embodiment 2

[0099]The preparation of step 1 reference substance solution, the method is as follows:

[0100] Accurately weigh appropriate amounts of gallic acid, catechin, and ellagic acid reference substances, respectively, and add methanol to prepare corresponding reference substance solutions to obtain a mass concentration of gallic acid of 0.5451mg.mL -1 , The mass concentration of catechin is 0.5079mg.mL -1 , the mass concentration of ellagic acid is 0.5067mg.mL -1 of the reference solution.

[0101] Step 2 Preparation of unhydrolyzed sample solution

[0102] Accurately weighed 0.1 g of salvianolic acid for injection, dissolved in 10 ml of 60% acetone, ultrasonicated for 30 min, and filtered through a 0.22 um microporous membrane to obtain the product.

[0103] Step 3 Preparation of hydrolyzed sample solution

[0104] Accurately weigh 0.1 g of salvianolic acid for injection, dissolve it in 5 ml of 60% acetone, then add 5 ml of 2mol / L hydrochloric acid solution, and hydrolyze at 1...

Embodiment 3

[0119] The preparation of step 1 reference substance solution, the method is as follows:

[0120] Accurately weigh appropriate amounts of gallic acid, catechin, and ellagic acid reference substances, respectively, and add methanol to prepare corresponding reference substance solutions to obtain a mass concentration of gallic acid of 0.5451mg.mL -1 , The mass concentration of catechin is 0.5079mg.mL -1 , the mass concentration of ellagic acid is 0.5067mg.mL -1 of the reference solution.

[0121] Step 2 Preparation of unhydrolyzed sample solution

[0122] Accurately weighed 0.1 g of salvianolic acid for injection, dissolved in 10 ml of 60% acetone, ultrasonicated for 30 min, and filtered through a 0.22 um microporous membrane to obtain the product.

[0123] Step 3 Preparation of hydrolyzed sample solution

[0124] Accurately weigh 0.1 g of salvianolic acid for injection, dissolve it in 5 ml of 60% acetone, then add 5 ml of 2mol / L hydrochloric acid solution, and hydrolyze at ...

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Abstract

The invention provides a method for detecting tannin substance in salvianolic acid. The method for detecting tannin substance in salvianolic acid comprises the following steps of: firstly, preparing a reference solution; secondly, dissolving salvianolic acid to obtain an unhydrolyzed sample solution before hydrolysis; thirdly, dissolving salvianolic acid and then hydrolyzing, so as to obtain a hydrolyzed sample solution; fourthly, determining gallic acid, catechinic acid and ellagic acid in the unhydrolyzed sample solution, the hydrolyzed sampled solution and the reference solution; and fifthly, comparing chromatograms and judging whether the tannin substance exists in salvianolic acid.

Description

technical field [0001] The invention relates to the field of medical detection, in particular to a method for the exclusionary detection of tannins in salvianolic acid for injection. Background technique [0002] Tannins, also known as tannins, are a class of polyphenolic compounds with complex structures existing in plants. Tannins can be divided into two categories according to their chemical structure: hydrolyzable tannins and condensed tannins. According to the different phenolic acids obtained after hydrolysis, hydrolyzable tannins can be divided into gallic acid tannins and reverse gallic acid tannins (ellagic acid tannins). Since tannins are composed of gallic acid, ellagic acid and catechin, they form dimers, trimers, oligomers and polymers through various combinations. Therefore, by measuring the situation of gallic acid, catechin, and ellagic acid in the sample before and after hydrolysis, it can indirectly reflect the situation of tannins in the sample. [0003...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88G01N30/06
Inventor 叶正良薛静李德坤周大铮
Owner TIANJIN TASLY ZHIJIAO PHARMA
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