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Method for detecting the quality of the medicine combination for treating cerebral apoplexy and vasculitis

A quality detection method and composition technology, which is applied in the direction of drug combinations, pharmaceutical formulas, measuring devices, etc., can solve the problems of undisclosed quality detection methods, poor stability of ferulic acid, undisclosed drug ratio relationship and preparation methods, etc.

Active Publication Date: 2007-10-31
JIANGSU KANGYUAN SUNSHINE PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Tongsaimai Tablets, a drug for treating cerebral apoplexy and vasculitis, is a standard drug of the State Food and Drug Administration. The drug composition is disclosed in the standard, but the drug ratio relationship and preparation method are not disclosed. The quality testing method is disclosed. Ferulic acid has poor stability and will naturally degrade, which is not conducive to the control of the quality stability of the finished product of Tongsaimai Tablets; the application number is 03113176. "invention application, which discloses the composition and proportioning relationship of the drug, but does not disclose the quality testing method

Method used

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  • Method for detecting the quality of the medicine combination for treating cerebral apoplexy and vasculitis
  • Method for detecting the quality of the medicine combination for treating cerebral apoplexy and vasculitis
  • Method for detecting the quality of the medicine combination for treating cerebral apoplexy and vasculitis

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Experimental program
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Effect test

Embodiment 1

[0214] Astragalus 420kg, Angelica 530kg, Codonopsis 420kg, Scrophulariaceae 530kg, Honeysuckle 420kg, Dendrobium 530kg, Achyranthes bidentata 420kg, Licorice 530kg;

[0215]Put the raw material medicine into the multifunctional extraction tank, add 6 times the amount of water, heat and decoct for 0.5 hours, and start timing when the temperature in the pot reaches 100°C; filter to obtain filtrate I, and put it into the liquid storage tank for later use; Decoct 4 times the amount of water for 0.5 hours, filter, and combine with filtrate I to obtain filtrate II, and discard the dregs; put filtrate II into a double-effect concentrator, control the temperature below 70°C, and vacuum degree above -0.05Mpa Heat and concentrate to a relative density of 1.10-1.29 at 50-60°C, collect the thick paste I; take the thick paste I and put it in an alcohol sink, add ethanol until the alcohol content reaches 70%, stir well, and let it stand for more than 24 hours; take the above The clear liqui...

Embodiment 2

[0220] Astragalus 480kg, Angelica 480kg, Codonopsis 480kg, Scrophulariae 480kg, Honeysuckle 480kg, Dendrobium 480kg, Achyranthes bidentata 480kg, Licorice 480kg;

[0221] Add the raw material medicine into the multifunctional extraction tank, add 5 times the amount of water, heat and cook for 1.5 hours, and start timing when the temperature in the pot reaches 100°C; filter to obtain filtrate I, and put it into the liquid storage tank for later use; Decoct 3 times the amount of water for 1 hour, filter, combine with filtrate I to obtain filtrate II, and discard the dregs; put filtrate II into a double-effect concentrator, control the temperature below 70°C, and vacuum degree above -0.05Mpa Heat and concentrate to a relative density of 1.10-1.29 at 50-60°C, collect the thick paste I; take the thick paste I, put it in an alcohol sink, add ethanol until the alcohol content reaches 60%, stir well, and let it stand for more than 24 hours; The clear liquid is filtered, and the ethano...

Embodiment 3

[0226] Astragalus 480kg, Angelica 480kg, Codonopsis 480kg, Scrophulariae 480kg, Honeysuckle 480kg, Dendrobium 480kg, Achyranthes bidentata 480kg, Licorice 480kg;

[0227] Add the raw material medicine into the multifunctional extraction tank, add 5 times the amount of water, heat and cook for 1.5 hours, and start timing when the temperature in the pot reaches 100°C; filter to obtain filtrate I, and put it into the liquid storage tank for later use; Decoct 3 times the amount of water for 1 hour, filter, combine with filtrate I to obtain filtrate II, and discard the dregs; put filtrate II into a double-effect concentrator, control the temperature below 70°C, and vacuum degree above -0.05Mpa Heat and concentrate to a relative density of 1.10-1.29 at 50-60°C, collect the thick paste I; take the thick paste I, put it in an alcohol sink, add ethanol until the alcohol content reaches 60%, stir well, and let it stand for more than 24 hours; The clear liquid is filtered, and the ethano...

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Abstract

The invention provides a quality detection method for pharmaceutical compositions for treating stroke and vasculitis through a TLC qualitative identification method for Dendrobium nobile, pilose asiabell root, scrophularia root, licorice root, astragalus root, glycyrrhizic acid,wherein a HPLC content determination process and content regulation are conducted to sweet-scented osmanthus glycoside and astragalus root saponins. The invention discloses the research development of the preparation fingerprint pattern and optimization for conditions of the fingerprint pattern apparatus including chromatographic column, mobile phase and detecting wave length, as a result the liquid phase fingerprint spectrogram standard for the oral liquid preparations is drafted.

Description

technical field [0001] The invention relates to a quality detection method of a pharmaceutical composition, in particular to a quality detection method of a pharmaceutical composition for treating cerebral apoplexy and vasculitis. Background technique [0002] Stroke refers to the most common neurological disease caused by various cerebrovascular lesions and characterized by acute onset and loss of brain function, including embolism, thrombosis, and blood supply insufficiency. Vaso-occlusive vasculitis, referred to as vasculitis, is an inflammatory and vaso-occlusive disease that invades blood vessels, mainly invading small and medium arteries of the lower extremities, and can cause vascular occlusion, inflammation, lower extremity ulcers, and gangrene. Tongsaimai Tablets, a drug for treating cerebral apoplexy and vasculitis, is a standard drug of the State Food and Drug Administration. The drug composition is disclosed in the standard, but the drug ratio relationship and pr...

Claims

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Application Information

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IPC IPC(8): A61K36/8984G01N30/02G01N30/86G01N30/90A61P9/10
Inventor 夏月陈荣明李吉峰殷书梅束建清周树云王宓
Owner JIANGSU KANGYUAN SUNSHINE PHARMA CO LTD
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