Medical preparation of nodules of breast for treating gynaopathy and preparation method and quality control method

A quality control method and technology for gynecological diseases, applied in diseases, medical formulas, drug combinations, etc., can solve problems such as complex ingredients of traditional Chinese medicine compound preparations, lack of research, and inability to fully and accurately reflect the overall quality

Inactive Publication Date: 2007-05-02
BEIJING QI YUAN YI DE PHARMA RESEARCH CENTER
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The existing extraction process of this prescription has no research on some important process parameters, such as the amount of water added, so the rationality of the process needs to be demonstrated
At the same time, the curative effect of the drug can only be guaranteed under the premise of quality control, and the existing quality standards of this product only include physical and chemical identification, identification and content determination of berberine hydrochloride, which cannot fully and accurately reflect the preparation total quality of
The chemical composition of traditional Chinese medicine is complex. Often there are dozens to hundreds of chemical components in each medicinal material, and no less than a few known biologically active ingredients. The composition of traditional Chinese medicine compound preparations containing several medicinal materials is even more complex. for complex

Method used

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  • Medical preparation of nodules of breast for treating gynaopathy and preparation method and quality control method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0186] Take 73g of Gongluomu, 50g of Sanchaku, 50g of Motherwort, 50g of Caulis Spatholobus, 60g of Smilax Smilax, 50g of Forsythia, decoct twice, add 10 times the amount of water for 2 hours for the first time, and add 8 times for the second time Measure water and decoct for 1.5 hours; combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a clear paste with a relative density of 1.17-1.19 at 60°C, and vacuum-dry to obtain extract powder. The ratio is 1:1.5, mix well, drop into the coolant simethicone, the dripping conditions are as follows: melting temperature 75°C, heat preservation dripping, cooling temperature 25°C, inner / outer diameter of the dropper is 4.3mm / 5.1mm, The dripping distance is 5cm, the dripping speed is 35d / min, and the dripping pills are obtained, orally, 30 pills at a time, 3 times a day.

Embodiment 2

[0188]Take 73g of Gongluomu, 50g of Sanchaku, 50g of Motherwort, 50g of Caulis Spatholobus, 60g of Smilax Smilax, 50g of Forsythia, decoct twice, add 10 times the amount of water for 2 hours for the first time, and add 8 times for the second time Measure water and decoct for 1.5 hours; combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a clear paste with a relative density of 1.17-1.19 at 60°C, and vacuum-dry to obtain extract powder. The ratio is 1:1, mix well, drop into the coolant simethicone, the dripping conditions are as follows: melting temperature 70°C, heat preservation dripping, cooling temperature 20°C, inner / outer diameter of the dropper is 4.3mm / 5.1mm, The dripping distance is 3cm, and the dripping speed is 30d / min, and the dripping pill is obtained.

Embodiment 3

[0190] Take 73g of Gongluomu, 50g of Sanchaku, 50g of Motherwort, 50g of Caulis Spatholobus, 60g of Smilax Smilax, 50g of Forsythia, decoct twice, add 10 times the amount of water for 2 hours for the first time, and add 8 times for the second time Measure water and decoct for 1.5 hours; combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a clear paste with a relative density of 1.17-1.19 at 60°C, and vacuum-dry to obtain extract powder. The ratio is 1:2, mix well, drop into the coolant simethicone, the dripping conditions are as follows: melting temperature 80°C, heat preservation dripping, cooling temperature 30°C, inner / outer diameter of the dropper is 4.3mm / 5.1mm, The dripping distance is 7cm, and the dripping speed is 40d / min, and the dripping pill is obtained.

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Abstract

A Chinese medicine in the form of dispersing tablet, dripping pill, soft-capsule, particle, micropill, or injection for treating breast nodule, breast lobule hyperplasia, ovarian cyst, hysterompoma, etc is prepared from 6 Chinese-medicinal materials including motherwort, spatholobus stem, China root, forsythia fruit, etc. Its preparing process and quality control method are also disclosed.

Description

technical field [0001] The invention relates to a Rupi Anxiao pharmaceutical preparation for treating gynecological diseases, a preparation method and a quality control method, and belongs to the technical field of traditional Chinese medicine. technical background [0002] Breast addiction, breast lobular hyperplasia, ovarian cysts, and uterine fibroids are common and frequently-occurring diseases in women, and they are more common in women aged 25 to 45. In my country, cystic changes of mammary gland hyperplasia are rare, mostly glandular hyperplasia, so it is often called "mammary gland hyperplasia". The World Health Organization (WHO) collectively refers to "benign breast dysplasia". The risk of malignant transformation of this disease is 2-4 times higher than that of normal women, and the clinical symptoms and signs are sometimes mixed with breast cancer. Its main clinical features are breast lumps and breast pain, which are usually aggravated in the premenstrual peri...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/896A61K9/00A61P15/14G01N30/90G01N30/02
Inventor 于文风
Owner BEIJING QI YUAN YI DE PHARMA RESEARCH CENTER
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