Detection method of Xiaoer Huatan Zhike Granules

A technology for resolving phlegm, relieving cough, and detection method, which is applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve the problems of too simple quality control indicators, inability to control product quality, and affect product quality, etc., so as to ensure clinical efficacy and quality detection methods. Ease of use, the effect of simplified extraction methods

Active Publication Date: 2014-10-15
贵州省科晖制药有限公司
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  • Summary
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  • 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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  • Detection method of Xiaoer Huatan Zhike Granules
  • Detection method of Xiaoer Huatan Zhike Granules
  • Detection method of Xiaoer Huatan Zhike Granules

Examples

Experimental program
Comparison scheme
Effect test

experiment example

[0015] Experimental example: Determination of content of emetine hydrochloride, emetine hydrobromide and ephedrine hydrochloride

[0016] (1) Selection of mobile phase:

[0017] Mobile phase 1: water-acetonitrile-0.1% phosphoric acid (90:10:0.1);

[0018] Mobile phase 2: acetonitrile-methanol-0.1% phosphoric acid (12:2:15:86);

[0019] Mobile phase 3: 0.05mol / l potassium dihydrogen phosphate-methanol-acetonitrile-triethylamine (80:10:10:0.3);

[0020] Mobile phase 4: 0.05mol / l potassium dihydrogen phosphate-methanol-acetonitrile-triethylamine (75:7:18:0.4);

[0021] Mobile phase 5: 0.01mol / l potassium dihydrogen phosphate-acetonitrile-(90:10:0.1);

[0022] Mobile phase 6: 0.01mol / l potassium dihydrogen phosphate-acetonitrile-phosphoric acid-triethylamine (90:5:0.2:0.2);

[0023] Mobile phase 7: 0.01mol / l potassium dihydrogen phosphate-acetonitrile-triethylamine-phosphoric acid (89:11:0.4:0.2)

[0024] Through the analysis of the above comparative test results, mobile pha...

Embodiment

[0054] The quality detection method of Xiaoer Huatan Zhike Granules comprises the following steps:

[0055] (1) Identification of Morus alba:

[0056] 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 method for detecting the quality of Xiaoer Huatan Zhike Granules, which comprises using high performance liquid chromatography to determine the contents of emetine hydrochloride, emetine hydrobromide and ephedrine hydrochloride in Xiaoer Huatan Zhike Granules , each bag of 5g containing ephedrine hydrochloride should be 1.6mg ~ 2.2mg; each bag of this product containing ipecac should be 0.23 ~ 0.32mg based on the total amount of emetine hydrochloride and emetine hydrobromide. TLC identification of Morus alba, ephedrine hydrochloride and ipecac. The invention has high measurement efficiency, high precision and accurate content determination, so that the product quality can be effectively detected.

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. Background technique [0002] 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, and the qua...

Claims

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Application Information

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Patent Type & Authority Patents(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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