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Medicine composition fortreating hyperplasia of mammary glands and quality control method

A technology for breast hyperplasia and composition, which is applied in the directions of drug combination, testing drug preparations, and pharmaceutical formulations, can solve problems such as imperfection, and achieve the effects of controlling product quality, good reproducibility, and good separation.

Inactive Publication Date: 2006-08-09
谢黎
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the quality control method of traditional Chinese medicine composition preparations for the treatment of mammary gland hyperplasia has great defects and is not yet perfect

Method used

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Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0033] Experimental Example 1 Methodological investigation of content determination method

[0034] (1) Selection of measurement wavelength:

[0035] Do ultraviolet scanning on the reference substance of ginsenoside Rg1, and it can be seen from the spectrogram that: ginsenoside Rg1 has a maximum absorption value at 203nm, so the measurement wavelength is selected as 203nm.

[0036] (2) Determination of extraction solvent:

[0037] Accurately weigh 3 parts of concentrated pills of this medicinal composition, each 1.5g, use methanol, 70% ethanol, and n-butanol as solvents respectively, carry out HPLC measurement after ultrasonic treatment, record the integrated value of the peak area of ​​ginsenoside Rg1, and calculate the Content in the composition concentrated pill, the results are shown in Table 1:

[0038] extraction solvent

Methanol

70% ethanol

Butanol

Ginsenoside Rhl content (%)

0.2897

0.3010

0.1190

[0039] According t...

Embodiment 1

[0078] Embodiment 1: the preparation of concentrated pill

[0079] Notoginseng 75g, Cyperus cyperi 75g, star anise lotus 45g, ratwort 30g, black ant 30g, spiced vine 600g, chicken arrow vine 600g, golden buckwheat 600g, dahongpao 600g, bupleurum 400g.

[0080] Take the above ten flavors, take Panax notoginseng, Cyperus cyperi, Star anise lotus, rat woman insects, and black ants, grind them into fine powder, mix them well, and sterilize them for later use; add 10 times the amount of water to decoct the rest of the five flavors, and boil them for three times. 2 hours, 1.5 hours for the second time, 1 hour for the third time, combine, decoct, filter, concentrate the filtrate to a thick paste with a relative density of 1.25 at 60°C, spray dry or concentrate to an appropriate amount, mix with the above powder, and make Concentrated water pills.

Embodiment 2

[0081] Embodiment 2: the preparation of capsule

[0082] Notoginseng 61g, Cyperus cyperi 89g, star anise lotus 31g, ratwort 39g, black ant 21g, spiced blood vine 505g, chicken arrow vine 695g, golden buckwheat 525g, Dahongpao 675g, Bupleurum 305g.

[0083] Take the above ten flavors, take Panax notoginseng, Cyperus cyperi, star anise lotus, rat woman insects, and black ants, grind them into fine powder, mix them well, and sterilize them for later use; The second time is 2 hours, the second time is 1.5 hours, combined, decocted, filtered, the filtrate is concentrated to a thick paste with a relative density of 1.13 at 60°C, spray-dried or concentrated to an appropriate amount, mixed with the above powder, added with conventional excipients, and packed into capsules.

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Abstract

The invention discloses a quality control method for a Chinese medicinal combination for curing proliferation of mammary gland, prepared mainly of Radix Notoginseng, Rhizoma Cyperi, Common Dysosmatis Rhizome and Root, Pillbug Armadillidium, Black ant, Kadsura longipedunculata Finet, Paederia scandens(Lour.) Merr Wild Buckwheat Rhizome, Campglotroopis hirtella schindl and Chinese Thorowax Root. And it retains thin layer chromatographic identification on pseudo-ginseng and adds thin layer chromatographic identification on Chinese Thorowax Root and Rhizoma Cyperi; and adopts HPLC to determine the ginseng saponin Rg1 content of the pseudo-ginseng.

Description

field of invention [0001] The invention relates to a quality control method of a pharmaceutical composition, in particular to a quality control method of a pharmaceutical composition for treating mammary gland hyperplasia. Background technique [0002] Breast hyperplasia is a disease of abnormal proliferation of breast tissue, which belongs to the category of breast addiction in traditional Chinese medicine. It is characterized by highly dilated breast lobules, tubules, and unimplanted ducts, showing cystic changes. On the one hand, mammary gland hyperplasia manifests as cystic dilatation of mammary ducts, forming cysts of various sizes; hyperplasia. Due to the complex histological form of mammary gland hyperplasia, there are various histological classification methods, such as lobular hyperplasia, chronic mastitis, fibrocystic mastopathy, benign epithelial hyperplasia, and adenosis. [0003] Modern studies have shown that the occurrence of mammary gland hyperplasia is re...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/89A61K35/64A61P15/14G01N30/90G01N33/15
Inventor 谢黎
Owner 谢黎
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