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Chinese medicine dispersible tablets for treating hysteromyoma, preparing method and quality control method

A quality control method, technology of uterine fibroids, applied in the field of traditional Chinese medicine, can solve the problem of high drug concentration

Inactive Publication Date: 2008-12-17
ZHEJIANG DADE PHARMACEUTICAL GROUP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there are many medicines for treating uterine fibroids in the market. Among them, Gongliuqing Capsule, which is commonly used, has the effect of promoting blood circulation and removing stasis, eliminating symptoms and breaking accumulation, and nourishing blood heat. There are lumps in the dark, and the above-mentioned symptoms of uterine intramural fibroids and subserosal fibroids have a certain therapeutic effect; but this capsule has the disadvantages of high local drug concentration after the patient takes the medicine, and the dispersible tablet preparation is the only one in recent years. A kind of quick-acting preparation developed in the past, has the reputation of "solid oral liquid", which combines the advantages of tablets and oral liquid preparations, overcomes the shortcomings of both, and can solve the problems existing in existing capsule preparations

Method used

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  • Chinese medicine dispersible tablets for treating hysteromyoma, preparing method and quality control method
  • Chinese medicine dispersible tablets for treating hysteromyoma, preparing method and quality control method
  • Chinese medicine dispersible tablets for treating hysteromyoma, preparing method and quality control method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0198] Example 1 of the present invention: 240g of cooked rhubarb, 200g of ground beetle, 200g of leech, 180g of peach kernel, 160g of Puhuang, 120g of Scutellaria baicalensis, 180g of Citrus aurantii, 240g of oyster, 240g of rehmannia root, 180g of white peony, 60g of licorice, and cross-linked polyvinylpyrrolidone 225g, low-substituted hydroxypropyl cellulose 100g, micropowder silica gel 20g, magnesium stearate 2g, aspartame 3g

[0199] Take cooked rhubarb, wood beetle, leech, citrus aurantium, rehmannia glutinosa, puhuang, white peony root, and licorice eight herbs, add water to decoct twice, first add water to soak for 2 hours, after boiling, add peach kernels and scutellaria baicalensis and decoct for 1 hour , and filter; add water for the second time and decoct for 1 hour, filter, combine the two decoctions, and concentrate under reduced pressure at 65°C to a thick paste with a relative density of 1.20 at 60°C±5°C; decoct oysters with water twice, After soaking in water ...

Embodiment 2

[0200] Embodiment 2 of the present invention: quality control method comprises following part or all content:

[0201] Properties: The drug is brown to tan tablets; the gas is slightly fragrant, the taste is slightly sweet and slightly bitter;

[0202] Identification: (1) Take 2 tablets of this product, add 20ml of methanol, sonicate for 15 minutes, filter, take 5ml of the filtrate and evaporate to dryness, add 10ml of water to dissolve the residue, add 1ml of hydrochloric acid, heat on a water bath for 30 minutes, cool immediately, and use Diethyl ether was extracted twice, 20ml each time, the diethyl ether solution was combined, evaporated to dryness at low temperature, the residue was dissolved by adding 1ml of methanol, and used as the test solution; another 0.2g of rhubarb reference medicinal material was added, and 20ml of methanol was added to prepare the reference medicinal material solution in the same way; Take emodin reference substance, add methanol to make a solut...

Embodiment 3

[0215] Embodiment 3 of the present invention: quality control method may comprise the following content:

[0216] Properties: The drug is brown to tan tablets; the gas is slightly fragrant, the taste is slightly sweet and slightly bitter;

[0217] Identification: (1) Take 2 tablets of this product, add 20ml of methanol, sonicate for 15 minutes, filter, take 5ml of the filtrate and evaporate to dryness, add 10ml of water to dissolve the residue, add 1ml of hydrochloric acid, heat on a water bath for 30 minutes, cool immediately, and use Diethyl ether was extracted twice, 20ml each time, the diethyl ether solution was combined, evaporated to dryness at low temperature, the residue was dissolved by adding 1ml of methanol, and used as the test solution; another 0.2g of rhubarb reference medicinal material was added, and 20ml of methanol was added to prepare the reference medicinal material solution in the same way; Take emodin reference substance, add methanol to make a solution c...

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Abstract

The invention provides a traditional Chinese medicine dispersible tablet preparation for treating uterine fibroids, a preparation method and a quality control method. , oyster 240g, rehmannia glutinosa 240g, white peony root 180g, licorice 60g and appropriate auxiliary materials; compared with the prior art, the dispersible tablet of the present invention disintegrates rapidly and disperses evenly when it meets water, and has short disintegration time and dispersible Good condition; rapid drug dissolution, fast absorption, high bioavailability; suitable for large-scale industrial production; easy to take; fast absorption, convenient production, carrying, transportation, stable quality, etc. The quality control method of the invention is scientific and reasonable, has high precision and strong stability, and can effectively guarantee its clinical curative effect.

Description

Technical field: [0001] The invention relates to a traditional Chinese medicine dispersible tablet preparation for treating uterine fibroids, a preparation method and a quality control method, and belongs to the technical field of traditional Chinese medicines. Background technique: [0002] Uterine leiomyoma is a common benign tumor in gynecology, and its incidence rate is about 25% in women of childbearing age. It is one of the main reasons for hysterectomy in women of childbearing age. Traditional medicine believes that its pathogenesis is caused by blockage of Qi mechanism and internal stagnation of blood stasis. At present, there are many medicines for treating uterine fibroids in the market. Among them, Gongliuqing Capsule, which is commonly used, has the effect of promoting blood circulation and removing stasis, eliminating symptoms and breaking accumulation, and nourishing blood heat. There are lumps in the dark, and the above-mentioned symptoms of uterine intramura...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06A61K35/618A61K35/62A61K35/64
Inventor 陈法贵王天兴徐丽君
Owner ZHEJIANG DADE PHARMACEUTICAL GROUP CO LTD
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