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Quality control method of particles for eliminating phlegm and stopping cough for children

A quality control method, the technology of reducing phlegm and relieving cough, which is applied in the field of quality control of Xiaoer Huatan Zhike granule, can solve problems such as addiction, affecting product quality, and too simple quality control indicators, so that the quality control method is simple and easy to implement , to ensure clinical efficacy and safety

Inactive Publication Date: 2008-01-30
贵州省科晖制药有限公司
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  • Abstract
  • Description
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AI Technical Summary

Problems solved by technology

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
Platycodon grandiflorum 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 only provided a qualitative identification method for ephedrine hydrochloride and ipecac tincture, without any content determination and identification indicators of platycodon grandiflorum, and the quality control indicators were too simple to carry out product inspections. effective quality control

Method used

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  • Quality control method of particles for eliminating phlegm and stopping cough for children
  • Quality control method of particles for eliminating phlegm and stopping cough for children

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Embodiment 1: the investigation of ephedrine hydrochloride content determination method

[0019] 1. HPLC chromatographic conditions and preparation and screening of the test solution

[0020] We selected a variety of mobile phase systems to carry out HPLC chromatographic condition screening tests, and the results are shown in the table below.

[0021] Statistical table of chromatographic condition inspection data

[0022] method number

[0023] Through the analysis of the above comparative test results, method 5 has the characteristics of appropriate retention time and good sample separation effect, so it is used as ephedrine hydrochloride-containing mobile phase. Simultaneously according to follow-up test analysis summary, the number of theoretical plates when the separation degree of sample is 1.5 is 2965, therefore the theoretical plate number of regulation ephedrine hydrochloride is not less than 3000.

[0024] Preparation of the test solution Take t...

Embodiment 2

[0055] Embodiment 2: TLC identification of Platycodon grandiflorum medicinal material

[0056] Take 1g of the fine powder of this product, add 10ml of ethanol, heat to boiling, filter, evaporate the filtrate to dryness, add 2ml of dilute hydrochloric acid solution, hydrolyze in a water bath for 1h in a stoppered test tube, adjust the pH to 9-10 with concentrated ammonia water, add 1ml of chloroform, shake fully Shake, centrifuge, and use the chloroform layer as the test solution. Another 0.2 g of bellflower reference drug was taken, and the reference drug solution was prepared in the same way. According to the test of thin-layer chromatography (Appendix VIB, Chinese Pharmacopoeia 2005 Edition), draw 10 μl of each of the above two solutions, respectively spot on the same silica gel G thin-layer plate, and mix with ethyl acetate-butanone-formic acid-water (10: 0.5∶0.5∶0.2) as developing agent, develop, take out, dry in the air, and inspect under ultraviolet light (365nm). In t...

Embodiment 3

[0057] Embodiment 3: TLC identification of tincture of ipecac and ephedrine hydrochloride

[0058] Take about 7.5g of this product, add 15ml of water, heat to dissolve, let it cool, add 2ml of sodium hydroxide test solution, add sodium chloride to make it saturated, shake and extract with 30ml of ether twice, combine the ether solution, evaporate the ether to About 0.5ml, as the test solution. Take another ephedrine hydrochloride reference substance, add methanol to make a solution containing 1mg per 1ml, as the reference substance solution. Then take 2ml of tincture of ipecac reference substance, add 4ml of water, add 2ml of sodium hydroxide test solution, shake and extract twice with 20ml of ether, combine the ether solution, evaporate the ether to about 0.5ml, and use it as the reference substance of tincture of ipecac. According to the test of thin-layer chromatography (Appendix VI B, Chinese Pharmacopoeia, 2005 edition), draw 10-15 μl of each of the above three solutions...

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Abstract

The present invention discloses a quality control method of pediatric phlegm-resolving and cough-relieving granules, which pertains to the quality control field of the traditional Chinese medicine preparations. The present invention firstly establishes the content determination of the ephedrine hydrochloride in the pediatric phlegm-resolving and cough-relieving granules and the TLC identification of the radix platycodi medicinal material. The present invention includes the following steps: (1) determination of the content of ephedrine hydrochloride by HPLC, the ephedrine hydrochloride (C10H15NO HCl) in each bag (5g) of the product is 1.7 to 2.1mg; (2) the TLC identification of the radix platycodi in the pediatric phlegm-resolving and cough-relieving granules. The quality control method of the present invention has simple and easy operation, accuracy, reliability and high precision. The present invention can better control the quality of the traditional Chinese medicine granules, so as to ensure the safety of drugs, further to ensure the clinical efficacy of the drugs.

Description

technical field [0001] The invention belongs to the field of quality control of traditional Chinese medicine preparations, in particular to a quality control 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. Platycodon grandiflorum as a raw material, if it is not identified, 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 ...

Claims

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Application Information

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IPC IPC(8): A61K36/605A61P11/10A61P11/14G01N30/02G01N30/90A61K31/137A61K31/4738
Inventor 刘文炜高玉琼霍昕杨迺嘉刘建华
Owner 贵州省科晖制药有限公司
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