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Quality control method of 'sifangweipian'

A quantitative detection method and a quartet of technologies, applied in measuring devices, pharmaceutical formulations, medical preparations containing active ingredients, etc., to improve specificity and quality stability, avoid false positive results, and ensure safety and effectiveness.

Active Publication Date: 2010-10-06
GUANGZHOU BAIYUNSHAN QIXING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The purpose of the present invention is to overcome the qualitative identification method of only two kinds of medicinal materials in the current quality standard of Sifangwei Tablets, the specificity is not strong, and it is not conducive to controlling product quality. Disadvantages, provide a qualitative and quantitative detection method for Sifangwei Tablets with strong specificity and more accurate control of product quality

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0021] The present invention will be further described below in conjunction with embodiment.

[0022] Get the Sifang stomach tablet that the batch number produced by the applicant is 5012.

[0023] 【Identification】(1) Take this product, mount it in dilute glycerin, and observe it under a microscope: the starch grains are oval, 35-48 μm in diameter, umbilicus-shaped, herringbone-shaped or horseshoe-shaped, located at the smaller end, with fine and dense layers. (Zhejiang Fritillaria). Irregular transparent flakes or fragments with fine stripes or reticular texture (sea octopus). Take this product, add an appropriate amount of dilute hydrochloric acid, soak for a while, filter, take an appropriate amount of filter residue and permeabilize it with chloral hydrate, mount it on a slice, and observe under a microscope: the testa epidermal cells are connected with the reddish-brown pigment layer cells, and the surface view is polygonal. The cell cavity is not obvious, with denser g...

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PUM

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Abstract

The invention relates to a quality control method of a four-ingredient stomach tablet, which increases the following steps in the original quality control method: (1) the invention adopts the microscopic identification method for the identification of thunberg fritillary bulb, cuttlebone, Szechwan Chinaberry fruit and bitter apricot seed which are contained in the four-ingredient stomach tablet; (2) the invention adopts the thin layer chromatography and uses the yanhusuo control medicine and the tetrahydropalmatine positive control for the identification of yanhusuo which is contained in the four-ingredient stomach tablet; (3) the invention adopts the high performance liquid chromatography for the measurement of the content of berberine hydrochloride; the quality control method of the four-ingredient stomach tablet of the invention can not only increase the content measurement method of the active ingredients and the qualitative identification method, but also improve the specificity and quality stability of the quality control method of the four-ingredient stomach tablet, so the invention can ensure the safety and effectiveness of the medicine. The quality control method of the four-ingredient stomach tablet of the invention can not only be used for the control of the quality of the four-ingredient stomach tablet, but also control the quality of other formulations, such as capsules, granules and so on with the same prescription.

Description

Technical field [0001] The present invention involves the qualitative and quantitative detection method of proprietary Chinese medicines. Specifically, the invention involves the qualitative and quantitative detection method of Chinese pads. Background technique [0002] Sifang gastric tablets are a patent -making Chinese patent medicine. It has been listed in my country for many years. It is clinically used in stomach pain, excessive gastric acid, indigestion, stomach and duodenal ulcer.Sifang gastric tablets are prepared by traditional Chinese herbal medicine Haiyu, Zhejiang Fritillaria, Agarwood, Coptis chinensis, Sichuan Skinzi, Shishuang, Bite Almond, Yanhu Mo, and Evodia.The quality standards of this product are collected in the "Pharmaceutical Standards for the Ministry of Health of the People's Republic of China", the 14th volume of the Chinese medicine prescription preparation, the standard number WS 3 -B-0911-91.In this standard, there are only the qualitative identifi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K36/8966A61P1/04A61P1/14G01N30/02G01N30/90A61K35/56
Inventor 于永洲刘声波徐文流黄夏敏邓祝玲
Owner GUANGZHOU BAIYUNSHAN QIXING PHARMA
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