Preparation for treating hysteritis and its quality control method

A quality control method and preparation technology, which is applied in the direction of testing pharmaceutical preparations, pill delivery, and pharmaceutical formulations, and can solve problems such as difficulty in controlling the quality of Gongyanping preparations

Active Publication Date: 2006-08-30
GUANGDONG LUOFUSHAN SINOPHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In the standard of Gongyanping Tablets in the seventeenth volume of "Prescriptions of Traditional Chinese Medicine", for the quality control of Gongyanping preparations, only the TLC identification of the medicinal materials of Diren and Liangmian, this quality standard is difficult to control Gongyanping preparations the quality of

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] Embodiment 1: A kind of film-coated tablet preparation containing gallic acid, diamanthine chloride, and ferulic acid Gongyanping at the same time

[0060] Diren 450g Liangmianzhen 170g Angelica 140g

[0061] Five Fingers Peach 100g Piercing Stone 140g

[0062] For the above five flavors, add water to decoct twice, each time for 2 hours, filter, combine the filtrate, concentrate to a relative density of 1.25 (55-60°C), add ethanol until the alcohol content reaches 50%, let stand for 24 hours, filter , the filtrate recovered ethanol, concentrated to a thick paste, dried at low temperature and pulverized into fine powder, added appropriate amount of auxiliary materials, mixed evenly, granulated, pressed into 1000 tablets, coated, and obtained.

[0063] The preparation is determined to contain gallic acid > 0.01 mg, acanthine chloride > 0.01 mg, and ferulic acid > 0.01 mg.

[0064] The detection method of gallic acid is:

[0065] Measure according to high performance li...

Embodiment 2

[0071] Embodiment 2: A kind of film-coated tablet preparation containing gallic acid, limpetine chloride, and ferulic acid Gongyanping at the same time

[0072] Diren 450g Liangmianzhen 170g Angelica 140g

[0073] Five Fingers Peach 100g Piercing Stone 140g

[0074] Reflux Diren and Angelica with 75% ethanol for 2.0 hours, recover the ethanol from the extract and use it for later use, add water and decoct the dregs and other three flavors after refluxing Diren and Angelica for 2 hours each time, filter, combine the filtrates, and concentrate To a relative density of 1.25 (55-60°C), add ethanol until the alcohol content reaches 50%, let stand for 24 hours, filter, recover ethanol from the filtrate, concentrate to a thick paste, combine with the above-mentioned ethanol extract, dry and pulverize at low temperature Fine powder, add appropriate amount of auxiliary materials, mix well, granulate, press into 1000 tablets, coat, and get ready.

[0075]The preparation is determined ...

Embodiment 3

[0076] Embodiment 3: A kind of film-coated tablet preparation containing gallic acid, limpetine chloride, and ferulic acid Gongyanping at the same time

[0077] Diren 450g Liangmianzhen 170g Angelica 140g

[0078] Five Fingers Peach 100g Piercing Stone 140g

[0079] Diren, Angelica, and Liangmianzhen were refluxed with 65% ethanol for 2.0 hours, and the ethanol was recovered from the extract solution for later use. Diren, Angelica, and Liangmianzhen’s refluxed medicinal residues and other two flavors were decocted twice, each time for 2 hours. Filter, combine the filtrates, concentrate to a relative density of 1.25 (55-60°C), add ethanol until the alcohol content reaches 50%, let it stand for 24 hours, filter, recover ethanol from the filtrate, concentrate to a thick paste, and mix with the above-mentioned ethanol The extracts are combined, dried at low temperature and pulverized into fine powder, added appropriate amount of auxiliary materials, mixed evenly, granulated, comp...

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Abstract

A Chinese medicine Gongyanping for treating gynecological inflammations is prepared from 5 Chinese-medicinal materials including shing bugleweed herb, zanthoxylum nitidum, Chinese angelica root, hispid fig root, etc. Its quality control method features that the efficient liquid-phase chromatographic analysis method or UV spectrophotometric method is used for measuring the content of tannin or gallic acid, and the thin-layer method is used to measure the contents of the one or more active components contained in its raw materials.

Description

field of invention [0001] The invention relates to a quality control method of gynecological traditional Chinese medicine preparations, in particular to a Gongyanping preparation (such as tablets, capsules, Dispersible tablets, granules, soft capsules, solutions, microcapsules, injections and other pharmaceutical dosage forms) and their quality control methods. Background technique: [0002] Chinese Patent No.: 00103132.5 "Gongyanping special-shaped film-coated tablet and its manufacturing method" discloses a preparation method of Gongyanping tablet. In recent years, with the in-depth research on Gongyanping preparations, the preparation method of new dosage forms of Gongyanping has attracted attention. For example, the patent application with application number 03118640.8 involves the preparation of a Gongyanping capsule, and the application with application number 200410045022.6 involves a The preparation of Zhonggongyanping dispersible tablets, such as application number...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/75A61K9/08A61K9/02A61K9/20A61K9/48A61P15/00G01N30/90G01N33/15
Inventor 叶耀良廖志钟
Owner GUANGDONG LUOFUSHAN SINOPHARM
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