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Quality detection method for RuanGanXiaoShui cataplasma

A quality inspection method and soft liver technology, applied in the digestive system, measuring devices, pharmaceutical formulas, etc., can solve the problems of qualitative and quantitative detection methods that do not reflect drug quality standards, cannot ensure drug efficacy, and cannot guarantee product quality, etc., to achieve Ensure efficacy and comprehensively reflect the effect of quality

Inactive Publication Date: 2011-08-03
THE FIFTH MEDICAL CENT OF CHINESE PLA GENERAL HOSPITAL
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  • Abstract
  • Description
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  • Application Information

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Problems solved by technology

[0003] Chinese patent applications CN 101269118A and CN 101269119A disclose the weight ratio of the components of Ruangan Xiaoshui cataplasm and the preparation method, but there is no qualitative and quantitative detection method reflecting the quality standard of the drug, so the quality of the product cannot be guaranteed, and thus cannot Ensure efficacy

Method used

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  • Quality detection method for RuanGanXiaoShui cataplasma
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  • Quality detection method for RuanGanXiaoShui cataplasma

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Experimental program
Comparison scheme
Effect test

Embodiment 1 10

[0029] The TLC identification of embodiment 1 Panax notoginseng

[0030] 1) Preparation of the test solution:

[0031] Take 1 sticker of this product, cut it into pieces, add 50mL of water-saturated n-butanol, seal it, place it for 24h, treat it ultrasonically for 30min, take n-butanol solution, wash with 50mL of ammonia test solution, discard the ammonia solution, and wash with water 3 times , 30 mL each time, take the n-butanol layer and evaporate to dryness, add 1 mL of methanol to the residue to dissolve, transfer to a 10 mL volumetric flask, add methanol to the mark, shake well, and use it as the test solution;

[0032] 2) Preparation of reference substance solution:

[0033] Ginsenoside Rb 1 , Ginsenoside Rg 1 and notoginsenoside R 1 1mg each of the reference substances, mix, add 1mL of methanol, as the reference substance solution;

[0034] 3) Preparation of negative sample solution:

[0035] Take 1 paste of the negative sample lacking Panax notoginseng, and prepa...

Embodiment 2

[0037] The TLC identification of embodiment 2 cinnamon

[0038] 1) Preparation of the test solution:

[0039] Take 1 paste of this product, cut it into pieces, add 50mL of ethanol, seal it, place it for 12h, ultrasonicate it for 30min, filter, and the filtrate is used as the test solution;

[0040] 2) Preparation of reference substance solution:

[0041] Get cinnamon aldehyde reference substance, add ethanol and make the solution that concentration is 2 μ g / mL, as reference substance solution;

[0042] 3) Preparation of negative sample solution:

[0043] Get 1 paste of the negative sample lacking cinnamon, prepare by the preparation method of need testing solution;

[0044] 4) According to the thin-layer chromatography test, draw 5 μL of each of the above three solutions, spot them on the same silica gel G thin-layer plate, use cyclohexane-ethyl acetate = 9:1 as the developing solvent, pre-saturate for 10 minutes, and develop upward , with a span of 8cm, take it out, dry i...

Embodiment 3

[0045] Embodiment 3 Assay

[0046] 1. Instruments and reagents

[0047] Agilent1100 high performance liquid chromatography, G1311A quaternary pump, G1322A degasser, G1315B DAD detector, HP chemstation chemical chromatography workstation; AL204 Mettler Toledo analytical balance (Switzerland); RC-3B drug dissolution apparatus (Tianjin University Radio Factory).

[0048] Acetonitrile (chromatographically pure Fisher Chemical), other reagents are analytically pure, double distilled water; microporous membrane (0.45μm); Rugan Xiaoshui cataplasm (homemade); ginsenoside Rg 1 Reference substance, ginsenoside Rb 1 Reference substance and notoginsenoside R 1 Reference substance (National Institute for the Control of Pharmaceutical and Biological Products).

[0049] 2. Chromatographic conditions

[0050] Chromatographic column: Kromasil ODS (250×4.6mm, 5μm); mobile phase: acetonitrile (A) and water (B), gradient elution was carried out according to the ratio in Table 1, and the flow ra...

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Abstract

The invention relates to a quality detection method for RuanGanXiaoShui cataplasma, comprising qualitative identification of a notoginseng medicinal material and a cinnamon medicinal material, as well as assaying of ginsenoside Rg1, ginsenoside Rb1 and notoginsenoside R1 in the notoginseng medicinal material. By the method disclosed by the invention, the quality of the RuanGanXiaoShui cataplasma can be effectively evaluated, thus facilitating control of the quality and ensuring the drug effect of the product.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicine preparations, and in particular relates to a quality detection method for Ruangan Xiaoshui cataplasm. Background technique [0002] Ruangan Xiaoshui Catapult is a transdermal drug delivery preparation developed by PLA 302 Hospital. It is mainly composed of Panax notoginseng, Gansui and cinnamon. It also has good effects of lowering enzymes and protecting the liver, promoting gallbladder and reducing jaundice, and resisting liver fibrosis. It can overcome the side effects of diuretic treatment or surgical treatment, and realize the effect of removing water, softening the liver, and treating both symptoms and root causes. [0003] Chinese patent applications CN 101269118A and CN 101269119A disclose the weight ratio of the components of Ruangan Xiaoshui cataplasm and the preparation method, but there is no qualitative and quantitative detection method reflecting the quality standard of the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/54A61P1/16A61P7/10G01N30/36G01N30/90
Inventor 张萍肖小河鄢丹任永申付强
Owner THE FIFTH MEDICAL CENT OF CHINESE PLA GENERAL HOSPITAL
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