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Quality control method of traditional chinese medicine preparation for treating traumatic injury and rheumatism ostealgia

A quality control method and rheumatic bone pain technology, applied in the direction of testing pharmaceutical preparations, pharmaceutical formulas, non-central analgesics, etc., can solve the problem that the total solids cannot be clearly distinguished from the preparation, it is not a quality control method, and cannot meet the quality control of the preparation Questions such as requirements

Active Publication Date: 2008-03-12
广西壮族自治区花红药业集团股份公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] Clinical application has proved that the detection of total solids cannot clearly distinguish which ingredients are contained in the preparation, which is not a good quality control method, and the index control of alcohol content can only control the ethanol content in the preparation
The combination of the two cannot distinguish the active ingredients in the preparation, and cannot meet the requirements for quality control of the preparation

Method used

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  • Quality control method of traditional chinese medicine preparation for treating traumatic injury and rheumatism ostealgia
  • Quality control method of traditional chinese medicine preparation for treating traumatic injury and rheumatism ostealgia
  • Quality control method of traditional chinese medicine preparation for treating traumatic injury and rheumatism ostealgia

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] Inspection of swelling and pain-relieving tincture:

[0059] Test product: a tincture prepared from the above 21 traditional Chinese medicines, a commercially available product, produced by Guangxi Huahong Pharmaceutical Co., Ltd., batch number: 20060304

[0060] The specific operation process of the inspection method of the anti-tumor and pain-relieving tincture is as follows:

[0061] (1), the content assay method of the index component of Chinese vine

[0062] Chromatographic conditions and system suitability test use octadecylsilane bonded silica gel as filler; use acetonitrile-0.03 mol / liter potassium dihydrogen phosphate solution (adjust pH=3.10 with phosphoric acid) (25:75) as mobile phase; detect The wavelength is 346 nanometers; the number of theoretical plates is 7123 based on the peak of palmatine hydrochloride.

[0063] Preparation of reference substance solution Accurately weigh an appropriate amount of palmatine hydrochloride reference substance, and use...

Embodiment 2

[0087] Test product: swelling and pain relieving babu ointment prepared by adopting the above-mentioned 21 traditional Chinese medicines

[0088] (1), the content assay method of the index component of Chinese vine

[0089] Chromatographic conditions and system suitability test use octadecylsilane bonded silica gel as filler; use acetonitrile-0.03 mol / liter potassium dihydrogen phosphate solution (adjust pH=3.10 with phosphoric acid) (25:75) as mobile phase; detect The wavelength is 346 nanometers; the number of theoretical plates is 8024 based on the peak of palmatine hydrochloride.

[0090] Preparation of reference substance solution Accurately weigh an appropriate amount of palmatine hydrochloride reference substance, and use methanol with a volume concentration of 70% to make a solution containing 10 micrograms per milliliter.

[0091] Preparation of the test solution Take the product under the weight difference item, cut it into pieces, take about 1.5 grams, accurately w...

Embodiment 3

[0115] Using the method of selecting a combination, select any batch of anti-tumor and pain-relieving tincture for detection, and the combination method is shown in the following table:

[0116] table, Represents the selected quality control method, □ represents the unselected quality control method.

[0117]

[0118]

[0119]

[0120]

[0121] the result shows:

[0122] The above table lists all 3-8 method combinations in the quality inspection method of the present invention, and any combination can be selected for quality control of the anti-tumor and pain-relieving tincture, and the effect is better than the original quality standard.

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Abstract

The present invention discloses a quality control method of Chinese medicine for treating traumatic injuries and rheumatic pain. The present invention combines the index component content mensuration and the thin-layer chromatography detection method for Chinese medicine, so as to achieve the aim of controlling and evaluating the quality of the Chinese medicine. Compared with the traditional quality control method, the method provided by the present invention is more scientific, reasonable and effective. In terms of operation, the method provided by the present invention has the advantages of simple operation, accuracy and reliability, high precision and high practical value.

Description

technical field [0001] The invention relates to a quality control method of medicinal products derived from plant raw materials, in particular to a quality control method of traditional Chinese medicine preparations for treating bruises and rheumatic bone pain. Background technique [0002] Traditional Chinese medicine preparations for treating bruises and rheumatic bone pain, such as the product of Guangxi Huahong Pharmaceutical Co., Ltd., swelling and pain-relieving tincture. ". [0003] The traditional Chinese medicine preparation for treating bruises and rheumatic bone pain is prepared from raw materials with the following weight ratio: [0004] Woody fragrance 47 Fangfeng 47 Nepeta 47 [0005] Asarum47 Wujiapi47 Guizhi47 [0006] Achyranthes bidentata 47 Chuanxiong 47 Xu Changqing 47 [0007] Angelica dahurica 70 Curcuma 47 Eucommia 70 [0008] Big Luo Umbrella 100 Xiao Luo Umbrella 70 Double-sided needle 100 [0009] Huangteng 95 Gardenia 100 Triangle 70 [0010...

Claims

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Application Information

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IPC IPC(8): A61K36/758A61K36/9066A61P29/00A61P19/00G01N30/90G01N30/02G01N33/15
Inventor 韦飞燕周晟张艳华何伟龙
Owner 广西壮族自治区花红药业集团股份公司
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