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Injection formulation containing raw material herb red sage root and its quality control method

A quality control method and injection technology, applied in the field of traditional Chinese medicine, can solve problems such as insufficient stability, and achieve the effects of ensuring safety, advanced detection methods, and stable quality

Active Publication Date: 2006-06-21
YAAN THREE NINE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is also reported that preparative thin-layer chromatography is used for separation. This method has a small amount of preparation at one time, and the components are affected by oxygen in the air on the thin plate, so they are not stable enough.

Method used

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  • Injection formulation containing raw material herb red sage root and its quality control method
  • Injection formulation containing raw material herb red sage root and its quality control method
  • Injection formulation containing raw material herb red sage root and its quality control method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] The preparation of embodiment 1 salvianolic acid A and salvianolic acid B reference substance

[0040]Take 5 kg of Salvia miltiorrhiza, crush it, add four times the amount of water to decoct for 1 hour, let it cool, filter, decoct twice in the same way, combine the filtrate, concentrate to about 5 liters, add ethanol until the alcohol content is 75%, left overnight, filtered, took the filtrate, evaporated ethanol, extracted 3 times with chloroform, and discarded the chloroform solution. The aqueous layer was adjusted to pH 3 with hydrochloric acid, extracted three times with ethyl acetate, the ethyl acetate solution was combined, and the solvent was evaporated to obtain a yellow crystalline powder, which was the crude product.

[0041] The crude product was separated by silica gel column chromatography, the mobile phase was chloroform-ethyl acetate-formic acid (volume ratio 3:2:0.4), collected in sections, monitored by thin-layer chromatography, and the sections of the ...

Embodiment 2

[0058] The assay method of embodiment 2 salvianolic acid A and salvianolic acid B

[0059] Chromatographic conditions: use Inertsil C8-3 column 5um (250×4.6mm); acetonitrile-water-formic acid (volume ratio 24:76:0.8) as mobile phase; column temperature 25°C; flow rate: 1.0ml / min; detection wavelength: 280nm.

[0060] Preparation of reference solution: Accurately weigh about 5 mg of salvianolic acid A reference substance and salvianolic acid B reference substance respectively, put them in the same 50ml measuring bottle, add mobile phase to dissolve and dilute to the mark.

[0061] Preparation of the test solution: Precisely measure 2ml of Xiangdan injection or Danshen injection, put it in a 25ml measuring bottle, add mobile phase to dilute to the mark, shake well, filter, and take the filtrate for later use.

[0062] Determination method: Accurately draw 10 μl each of the reference substance solution and the test solution, inject it into the liquid chromatograph, calculate the...

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Abstract

The present invention is one kind of injection containing medicine material red sage, and each preparation unit contains salvianolic acid A 0.5-7.5 mg and salvianolic acid B 0.5-7.5 mg. The present invention also provides the quality control method for the injection, and the contents of salvianolic acid A and salvianolic acid B are controlled to ensure the safety and effectiveness of the injection. The detection method is advanced, accurate, simple and suitable for conventional analysis. The present invention is significant in controlling the quality of different kinds of injection containing red sage component.

Description

technical field [0001] The invention relates to an injection containing salvia miltiorrhiza as a raw material and a quality control method thereof, belonging to the field of traditional Chinese medicines. Background technique [0002] Both Xiangdan injection and Danshen injection are traditional Chinese medicine injections containing Danshen. The raw materials contain Danshen, which has the function of dilating blood vessels and increasing coronary blood flow. It is used to treat cardiovascular diseases such as angina pectoris and myocardial infarction. The application is very extensive. The active ingredients of Danshen include water-soluble ingredients and fat-soluble ingredients. The water-soluble ingredients are mainly salvianolic acids, such as salvianolic acids A, B, C, D, E, shikonic acid, rosmarinic acid, etc. In addition, there are Danshensu, protocatechualdehyde, protocatechuic acid and so on. The research results show that salvianolic acid components are the mai...

Claims

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Application Information

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IPC IPC(8): A61K36/537A61K31/343A61K31/58A61K125/00A61P9/10
Inventor 曾晓春
Owner YAAN THREE NINE PHARMA
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