Quality control method of radix rubiae-angelica Chinese material medical preparation for treating female metrorrhagia

A quality control method and technology for traditional Chinese medicine preparations, which are applied in measuring devices, instruments, scientific instruments, etc., can solve the problems of poor specificity of content determination, single index components, and incomplete identification of characteristics, so as to improve the technical level of products and ensure stability. And safety, production process strict and reasonable effect

Active Publication Date: 2017-11-03
GANSU LANYAO PHARMA CO LTD
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Problems solved by technology

[0004] The purpose of the present invention is to provide a quality control method for Qianzhi traditional Chinese medicine preparations, so as to solve the problems in the existing control methods of Qianzhi Chinese medicine preparations such as single index components, incomplete feature identification, and poor specificity of content determination, so as to more scientifically evaluate Qianzhi. The quality of Chinese medicine preparations of Qianzhi ensures the stability and safety of its quality, improves the technical level of products, realizes the use of modern analysis methods to comprehensively improve the quality standards of Chinese medicine preparations of Qianzhi, and provides a better guarantee for Qianzhi to go abroad

Method used

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  • Quality control method of radix rubiae-angelica Chinese material medical preparation for treating female metrorrhagia
  • Quality control method of radix rubiae-angelica Chinese material medical preparation for treating female metrorrhagia
  • Quality control method of radix rubiae-angelica Chinese material medical preparation for treating female metrorrhagia

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Effect test

Embodiment 1

[0070] Embodiment 1, is aimed at the quality control method of a kind of Qianzhi Chinese medicine preparation of treating women's uterine bleeding that dosage form is capsule, described identification method is:

[0071] Properties: Remove the capsule shell, and the content of Qianzhi traditional Chinese medicine preparation is brown powder; the smell is fragrant, pungent and slightly bitter.

[0072] Identification:

[0073] (1) The method of identifying madder in the prescription of Qianzhi traditional Chinese medicine preparation is: take 20 capsules of this product, remove the capsule shell, add 20ml of ether, leave it for 1 hour, shake it from time to time to extract, filter, evaporate the filtrate, add ethyl acetate to the residue 1ml to dissolve, as the test solution. In addition, 0.8 g of Rubia reference drug powder was taken, and the reference drug solution was prepared in the same way as the preparation method of the test solution. According to the thin-layer chrom...

Embodiment 2

[0094] Embodiment 2, is the quality control method of a kind of Qianzhi Chinese medicinal preparation for the treatment of women's uterine bleeding that dosage form is a tablet, and described identification method is:

[0095] Properties: This product is a film-coated tablet, brown after removing the coating: fragrant, pungent and slightly bitter.

[0096] Identification:

[0097] (1) The method of identifying madder in the prescription of Qianzhi traditional Chinese medicine preparation is: take 25 tablets of this product, remove the coating, grind finely, add 40ml of ether, let it stand for 1 hour, shake it from time to time to extract, filter, evaporate the filtrate, add the residue Dissolve 1ml of ethyl acetate as the test solution. Another 1.5 g of Rubia reference drug powder was used to make a reference drug solution in the same way as the preparation method of the test solution. According to the thin-layer chromatography test, draw 5 μl of each of the above two soluti...

Embodiment 3

[0118] Embodiment 3, aiming at the quality control method of the Qianzhi Chinese medicine preparation that the dosage form is a kind of treatment women's uterine hemorrhage, described identification method is:

[0119] Properties: Qianzhi pills are brown in color: fragrant, pungent and slightly bitter.

[0120] Identification:

[0121] (1) The method of identifying madder in the prescription of Qianzhi traditional Chinese medicine preparation is: take 23 pills of this product, grind it finely, add 30ml of ether, leave it for 1 hour, shake it from time to time to extract, filter, evaporate the filtrate, add ethyl acetate to the residue 1ml to dissolve, as the test solution. Another 1.2 g of Rubia reference drug powder was used to prepare a reference drug solution in the same way as the preparation method of the test solution. According to the thin-layer chromatography test, draw 5 μl of each of the above two solutions (the solution of the test sample is reserved for use), res...

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Abstract

The invention discloses a quality control method of radix rubiae-angelica Chinese material medical preparation for treating female metrorrhagia. The quality control method includes identification method and content measurement method of the Qianzhi Chinese material medical preparation; the identification is thin-layer chromatography identification performed on radix rubiae contrast drug, swertiamarin, pseudo-ginseng contrast medicinal materials, pseudo-ginseng saponin, ginsenoside, radix angelicae contrast medicinal materials, imperatorin, isoimperatorin, radix cyathulae contrast medicinal materials and cyasterone in the radix rubiae-angelica Chinese material medical preparation. The method is an analysis method for controlling medicine quality through controlling the activity component of the radix rubiae-angelica Chinese material medical preparation; the radix rubiae-angelica quality standard is improved and perfected; on the basis of departmental standard, the medicine quality control is improved, the quality stability and safety are guaranteed, the product technical level is improved; the quality standard of the radix rubiae-angelica Chinese material medical preparation is comprehensively promoted by means of a modern analysis method, thus the production technique of the radix rubiae-angelica is more strict and reasonable.

Description

technical field [0001] The invention belongs to the technical field of quality control of traditional Chinese medicines, and relates to a quality control method of Qian Zhi traditional Chinese medicine preparation for treating women's uterine bleeding. Background technique [0002] In the prior art, Qianzhi class traditional Chinese medicine preparations are mainly made from Rhizoma Achyranthes Radix, Panax notoginseng, madder, and Angelica dahurica. Preparation method: Chuan Achyranthes bidentata and Angelica dahurica are crushed into coarse powder, mixed with an equal amount of 70% ethanol, moistened, and treated according to the percolation method under the liquid extract and extract (an appendix of the Chinese Pharmacopoeia 2005 edition), with 10 times 70% ethanol was soaked in the solvent for 24 hours, then slowly percolated, the filtrate was filtered, the ethanol was recovered, concentrated to a relative density of about 1.10 (35°C), and spray-dried. Rubia (manufactur...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/90G01N30/02
CPCG01N30/02G01N30/90
Inventor 杨军张涛王志锋雷文贵侯红霞苏海燕
Owner GANSU LANYAO PHARMA CO LTD
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