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Quality control method of traditional Chinese medicine formulations for treating gynaecologic disease

A quality control method and technology for traditional Chinese medicine preparations, which are used in sexually transmitted diseases, pharmaceutical formulations, and medical preparations containing active ingredients, etc. The effect of counterfeit drugs

Inactive Publication Date: 2008-08-13
王雨良
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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 Volume 17 of "Prescriptions of Traditional Chinese Medicine", for the quality control of Gongyanping preparations, there is only TLC identification of the medicinal materials of Diren and Liangmian. This quality standard cannot control Gongyanping very well. The quality of Yanping preparation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Embodiment 1: A kind of Gongyanping tablet preparation

[0040] Diren 450g Liangmianzhen 170g Angelica 140g

[0041] Five Fingers Peach 100g Piercing Stone 140g

[0042] The above five flavors, except Diren, and other four herbs such as Liangmianzhen, are crushed into coarse powder, and the coarse powder and Diren are decocted twice, each time for 2 hours, filtered, and the filtrates are combined, concentrated in vacuum below 80°C to relative density It is 1.23~1.28 (55~60 ℃) clear paste, add ethanol until the alcohol content reaches 50%, let it stand for 24 hours, filter, recover ethanol from the filtrate, concentrate under reduced pressure to a relative density of 1.25~1.30 (55~60 ℃), vacuum-dried below 90℃, crushed into fine powder, added appropriate amount of auxiliary materials such as starch, mixed, made into granules, dried below 80℃, pressed into 1000 tablets, coated with sugar or film coating, to obtain.

[0043] The detection method of gallic acid is:

[00...

Embodiment 2

[0050] Embodiment 2: A kind of Gongyanping capsule preparation and content determination

[0051] Diren 450g Liangmianzhen 170g Angelica 140g

[0052] Five Fingers Peach 100g Piercing Stone 140g

[0053] (1) The above five flavors, except Diren, and other four-flavored medicinal materials such as Liangmianzhen, are crushed into coarse powder, and the coarse powder and Diren are decocted with water twice, each time for 2 hours, filtered, combined filtrate, and concentrated in vacuum below 80°C To the clear paste with a relative density of 1.23~1.28 (55~60°C), add ethanol until the alcohol content reaches 50%, let it stand for 24 hours, filter, recover ethanol from the filtrate, concentrate under reduced pressure until the relative density is 1.25~1.30( 55~60℃), vacuum-dried below 90℃, crushed into fine powder, added appropriate amount of starch and other auxiliary materials, mixed well, made into granules, dried below 80℃,

[0054] (2) Fill 500 capsules to get ready.

[0055...

Embodiment 3

[0062] Embodiment 3: A kind of Gongyanping dripping pill preparation and content determination

[0063] Diren 450g Liangmianzhen 170g Angelica 140g

[0064] Five Fingers Peach 100g Piercing Stone 140g

[0065] (1) The above five flavors, except Diren, and other four-flavored medicinal materials such as Liangmianzhen, are crushed into coarse powder, and the coarse powder and Diren are decocted with water twice, each time for 2 hours, filtered, combined filtrate, and concentrated in vacuum below 80°C To the clear paste with a relative density of 1.23~1.28 (55~60°C), add ethanol until the alcohol content reaches 50%, let it stand for 24 hours, filter, recover ethanol from the filtrate, concentrate under reduced pressure until the relative density is 1.25~1.30( 55~60℃), vacuum-dried below 90℃, crushed into fine powder, added appropriate amount of auxiliary materials, mixed evenly, dripped or pressed into pellets, dried below 80℃,

[0066] (2) Make 5000 grains, that is to say.

...

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Abstract

The present invention relates a method for preparing gongyanping tablet and controlling quality. The gongyanping tablet is prepared from five Chinese traditional medicines including diren, shinyleaf pricklyash root, angelica, chuanposhi (tuomu), wuzhimaotao. The method comprises identifying and content determinating which takes octadecylsilane chemically bonded silica as filling agent; acetonitrile -0.05% phosphoric acid (3:97) as flowing phase; detecting wavelength 272nm; detecting the amount of gallic acid contained in manufactured goods each unit.

Description

field of invention [0001] The present invention relates to the preparation and quality control method of a gynecological traditional Chinese medicine preparation, in particular to the preparation of a Gongyanping tablet made from five traditional Chinese medicines such as Diren, Liangmianzhen, Angelica, Chuanposhi (Zhemu) and Wuzhi Maotao. and its 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 applica...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/758A61K9/16A61K9/28A61K9/46A61K9/48A61P15/00G01N30/36G01N30/90
Inventor 王雨良杨敏宋春光
Owner 王雨良
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