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Quality test method of phlegm eliminating and cough stopping granules for children

A quality inspection method and technology for resolving phlegm and relieving cough, which are applied in measurement devices, instruments, scientific instruments, etc., can solve the problems of too simple quality control indicators, inability to control product quality, and affect product quality, and ensure clinical efficacy and quality inspection. The method is simple and easy to implement, and the effect of simplifying the extraction method

Active Publication Date: 2013-04-24
贵州省科晖制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Morus alba as a raw material, if it is not identified, it will affect the quality of the product
This product is included in the Ninth Volume of Standards issued by the Ministry of Pharmaceuticals of China, the standard number is WS 3 -B-1691-94, while the original standard of Xiaoer Huatan Zhike Granules (5g per bag) only provided a qualitative identification method for ephedrine hydrochloride and ipecac tincture, without content determination and identification indicators of Morus alba, and the quality control indicators were too high Simple, no effective quality control of the product

Method used

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  • Quality test method of phlegm eliminating and cough stopping granules for children
  • Quality test method of phlegm eliminating and cough stopping granules for children
  • Quality test method of phlegm eliminating and cough stopping granules for children

Examples

Experimental program
Comparison scheme
Effect test

experiment example

[0018] Experimental example: Determination of content of emetine hydrochloride, emetine hydrobromide and ephedrine hydrochloride

[0019] (1) Selection of mobile phase:

[0020] Mobile phase 1: water-acetonitrile-0.1% phosphoric acid (90:10:0.1);

[0021] Mobile phase 2: acetonitrile-methanol-0.1% phosphoric acid (12:2:15:86);

[0022] Mobile phase 3: 0.05mol / l potassium dihydrogen phosphate-methanol-acetonitrile-triethylamine (80:10:10:0.3);

[0023] Mobile phase 4: 0.05mol / l potassium dihydrogen phosphate-methanol-acetonitrile-triethylamine (75:7:18:0.4);

[0024] Mobile phase 5: 0.01mol / l potassium dihydrogen phosphate-acetonitrile-(90:10:0.1);

[0025] Mobile phase 6: 0.01mol / l potassium dihydrogen phosphate-acetonitrile-phosphoric acid-triethylamine (90:5:0.2:0.2);

[0026] Mobile phase 7: 0.01mol / l potassium dihydrogen phosphate-acetonitrile-triethylamine-phosphoric acid (89:11:0.4:0.2)

[0027] Through the analysis of the above comparative test results, mobile pha...

Embodiment

[0058] The quality detection method of Xiaoer Huatan Zhike Granules comprises the following steps:

[0059] (1) Identification of Morus alba:

[0060] Weigh 5g of the fine powder of this product, add 20ml of ethyl acetate, stir in a water bath at 50-60°C for 1 minute, filter, evaporate the filtrate to dryness, add 0.5ml of ethyl acetate to dissolve, and use it as the test solution. Take another 0.3g of Cortex Mori reference medicinal material, add 2ml of ethyl acetate, stir in a water bath at 50-60°C for 1 minute, let stand, and the supernatant liquid is the reference medicinal material solution. Take 15-20 μl of each of the above solutions, spot on the same silica gel G thin-layer plate, use petroleum ether-ethyl acetate-acetone-formic acid = 4:2:2:0.1 as the developer, develop, take out, dry in the air, and use ultraviolet light View under 365nm light. In the chromatogram of the test product, fluorescent spots of the same color appear at the positions corresponding to th...

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Abstract

The invention discloses a quality test method of phlegm eliminating and cough stopping granules for children. The quality test method includes: determining the emetine hydrochloride content, the cephaeline hydrobromide content and the ephedrine hydrochloride content of the phlegm eliminating and cough stopping granules for children with high performance liquid chromatography (HPLC), each bag of the phlegm eliminating and cough stopping granules for children of 5g contains 1.6-2.2mg of ephedrine hydrochloride, and each bag contains 0.23-0.32mg of emetine by the total amount of emetine hydrochloride and cephaeline hydrobromide. Thin-layer chromatography is applied to the root bark of the white mulberry, the ephedrine hydrochloride and the emetine. The quality test method of the phlegm eliminating and cough stopping granules for children is high in determination efficiency and precision and precise in determination content and thus can be used for effectively testing quality of products.

Description

technical field [0001] The invention belongs to the field of quality detection of traditional Chinese medicine preparations, in particular to a quality detection method of Xiaoer Huatan Zhike Granules. [0002] Background technique [0003] Xiaoer Huatan Zhike Granules are composed of platycodon grandiflorum, tincture of ipecac, ephedrine hydrochloride and Morus alba, which have the effect of eliminating phlegm and relieving cough, and are used for children with cough and bronchitis. Ephedrine hydrochloride is the main drug in the prescription, which is mainly used to treat cough and asthma. It is also one of the active ingredients in the prescription, but it is also addictive. The content of ephedrine hydrochloride directly affects the curative effect of the product. Tincture of ipecac is a natural expectorant, and it has a very good expectorant effect when used in small doses. Therefore, tincture of ipecac is used as raw material in many expectorant and cough medicines, a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88G01N30/90
Inventor 刘建华高玉琼霍昕崔伟杨迺嘉黎明
Owner 贵州省科晖制药有限公司
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