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Quality control method of traditional Chinese medicine compound preparation for treating osteoporosis

A quality control method and osteoporosis technology, which are applied in the quality control of traditional Chinese medicine compound preparations and the quality control field of traditional Chinese medicine compound preparations for the treatment of osteoporosis, can solve the problem of inappropriate quality control of traditional Chinese medicine compound preparations, and inappropriate traditional Chinese medicine compound preparations. TLC identification and other issues

Active Publication Date: 2015-03-04
GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARM CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In terms of TLC identification, there is no TLC identification item in the quality standard of Eucommia ulmoides contained in the 2010 edition of the "Chinese Pharmacopoeia". The identification of single medicinal materials is not applicable to the TLC identification of traditional Chinese medicine compound preparations made from Yigu Fang
In addition, through relevant literature search, although there are also reports on the content determination of related components in traditional Chinese medicine compound preparations containing Epimedium or Gentiana, and TLC identification of Eucommia ulmoides, Achyranthes bidentata or Lycium barbarum in some traditional Chinese medicine compound preparations, these The methods are also not suitable for the quality control of the traditional Chinese medicine compound preparation made from Yigufang

Method used

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  • Quality control method of traditional Chinese medicine compound preparation for treating osteoporosis
  • Quality control method of traditional Chinese medicine compound preparation for treating osteoporosis
  • Quality control method of traditional Chinese medicine compound preparation for treating osteoporosis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] 1. TLC identification of Eucommia ulmoides

[0063] Preparation of the test solution: Take 1g of Yigufang powder, add 25ml of methanol, ultrasonically treat for 30 minutes, filter, evaporate the filtrate to dryness, add 30ml of water to the residue to dissolve, shake and extract twice with ethyl acetate, 20ml each time, Discard the ethyl acetate solution, shake the aqueous solution with water-saturated n-butanol and extract twice, 20ml each time, combine the n-butanol extracts, evaporate to dryness, add 1ml of methanol to the residue to dissolve, and use it as the test solution.

[0064] Preparation of the reference medicinal material solution: take the Eucommia reference medicinal material, and prepare the reference medicinal material solution according to the preparation method of the test solution.

[0065] Preparation of reference substance solution: Take pinoresinol diglucoside reference substance and genipocuronide reference substance, and add methanol to make sol...

Embodiment 2

[0069] Embodiment 2: The specific operation steps are the same as in Example 1, except that in the preparation process of the test solution, the heating was refluxed for 1 hour.

Embodiment 3

[0070] Embodiment 3: The specific operation steps are the same as in Example 1, except that during the preparation of the test solution, 25 ml of ethanol was added, and ultrasonic treatment was performed for 2 hours.

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Abstract

The invention discloses a quality control method of a traditional Chinese medicine compound preparation for treating osteoporosis. The quality control method comprises the following steps: (1) by taking eucommia ulmoides as a contrast medicinal material and taking pinoresinol diglucoside and geniposidic acid as comparison products, carrying out qualitative identification on eucommia ulmoides in the traditional Chinese medicine compound preparation by adopting a thin-layer chromatography; (2) by taking radix achyranthis bidentatae as a contrast medicinal material and taking beta-ecdysterone as a comparison product, carrying out qualitative identification on radix achyranthis bidentatae in the traditional Chinese medicine compound preparation by adopting the thin-layer chromatography; (3) by taking wolfberry fruits as contrast medicinal materials, carrying out qualitative identification on the wolfberry fruits in the traditional Chinese medicine compound preparation by adopting the thin-layer chromatography; and (4) determining the content of three active components (or index components) including epimedium glucoside, gentiopicroside and loganin acid in the traditional Chinese medicine compound preparation by adopting a high performance liquid chromatography. According to the quality control method, the quality of the traditional Chinese medicine compound preparation can be controlled very well, and the stability of a product production process is monitored; and the quality of the traditional Chinese medicine compound preparation is stable, uniform and controllable.

Description

technical field [0001] The invention relates to a quality control method of a traditional Chinese medicine compound preparation, in particular to a quality control method of a traditional Chinese medicine compound preparation for treating osteoporosis, and belongs to the technical field of drug analysis. Background technique [0002] Yigu Fang is composed of medicinal materials such as Epimedium, Gentiana, Eucommia, Achyranthes bidentata, Lycium barbarum, etc. Its functions and indications are to invigorate the bone and generate marrow, promote blood circulation and relieve pain. It is used for osteoporosis caused by liver and kidney deficiency and blood stasis blocking collaterals Symptoms include soreness and pain in the waist and knees, and it is mainly used clinically for the prevention and treatment of osteoporosis. In the prescription, Epimedium is used as the monarch drug, which warms and invigorates the kidney yang, dispels wind and dredges collaterals. Eucommia inv...

Claims

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Application Information

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IPC IPC(8): G01N30/90G01N30/02
Inventor 王文楚严志标彭红英陆颂规江涛陈雪华杨滨宾刘敏珊程君璐
Owner GUANGZHOU BAIYUNSHAN JINGXIUTANG PHARM CO LTD
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