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Method for determining content of schisandrin in Yixinshu traditional Chinese medicine preparation

A technology for schisandrin A and traditional Chinese medicine preparations, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., and can solve the problems of unsuitable determination of schisandrin A in Yixinshu traditional Chinese medicine preparations, insufficient rigor of the determination method, and poor precision of instruments.

Inactive Publication Date: 2014-02-19
GUIZHOU XINBANG PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] "Chinese Herbal Medicine Volume 36 Supplement 2005" discloses a method "HPLC method for determination of schisandrin A in Gengnian'an tablets", "Liaoning Journal of Traditional Chinese Medicine 2005 Volume 32 No. 8" discloses a method "HPLC method for determination of The method of "Content of Schizandrin A in Schisandra granules", "Chinese Journal of Experimental Formulas, Volume 17, No. 10, May 2011" discloses a method of "Simultaneous determination of six lignans in Schisandra by HPLC", However, since the measuring objects are Gengnian'an tablets, Schisandra granules and Schisandra medicinal materials, it is not suitable for determining the content of Schisandrin A in Yixinshu traditional Chinese medicine preparations.
The patent application with the application number 200910102648.9 and titled "Quality Control Method of Schisandra in Yixinshu Traditional Chinese Medicine Preparation" discloses a method for the determination of Schisandrin A in Yixinshu traditional Chinese medicine preparation, but the determination method is not rigorous enough and has not been carried out. Comprehensive methodological investigation, and the precision of the instrument in this determination method is poor, and the stability of the test product is not good enough, so it cannot be used as a set of strict and reliable quality inspection standards

Method used

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  • Method for determining content of schisandrin in Yixinshu traditional Chinese medicine preparation
  • Method for determining content of schisandrin in Yixinshu traditional Chinese medicine preparation
  • Method for determining content of schisandrin in Yixinshu traditional Chinese medicine preparation

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Effect test

Embodiment 1

[0059] Determination of Schisandrin A in Yixinshu Capsules (commercially available):

[0060] (1) Chromatographic conditions and system suitability test: octadecylsilane bonded silica gel is used as filler; methanol: water = 65:35 is used as mobile phase; flow rate is 1.0mL min -1 ;The detection wavelength is 250nm; the column temperature is 30°C; the number of theoretical plates should not be less than 2000 based on the peak of schisandrin A;

[0061] (2) Preparation of reference substance solution: Accurately weigh 3.02mg of schisandrin A reference substance, place it in a 10mL volumetric flask, add methanol to dissolve and set the volume to the mark, and prepare a solution with a concentration of 0.302mg / mL, pass through 0.22μm The microporous membrane, take the continued filtrate, to obtain final product;

[0062] (3) Preparation of the test solution: take 30 capsules of Yixinshu capsules and mix them evenly; take 1g, accurately weigh it, put it in a 25mL volumetric flask...

Embodiment 2

[0065] Determination of Schisandrin A in Yixinshu Granules (commercially available):

[0066] (1) Chromatographic conditions and system suitability test: octadecylsilane bonded silica gel is used as filler; methanol: water = 75:25 is used as mobile phase; flow rate is 1.5mL min -1 ;The detection wavelength is 300nm; the column temperature is 34°C; the number of theoretical plates should not be less than 2000 based on the peak of schisandrin A;

[0067] (2) Preparation of reference substance solution: take an appropriate amount of schisandrin A reference substance, weigh it accurately, add methanol to make a solution containing 0.3 mg of schisandrin A per 1 mL, and obtain it;

[0068] (3) Preparation of the test solution: take 20g of Yixinshu Granules, mix well; take 1g, accurately weigh it, put it in a 25mL volumetric flask, add 20mL of methanol, and ultrasonicate for 20min; take it out, let it cool, and add methanol to the scale, shake well, filter, and take the filtrate to ...

Embodiment 3

[0071] Determination of Schisandrin A in Yixinshu Tablets (commercially available):

[0072] (1) Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel is used as filler; methanol: water = 70:30 is used as mobile phase; flow rate is 0.5mL min -1 ; The detection wavelength is 200nm; the column temperature is 28℃;

[0073] (2) Preparation of reference substance solution: Accurately weigh 3.22 mg of schisandrin A reference substance, place it in a 10 mL volumetric flask, add methanol to dissolve and set the volume to the mark to make a solution with a concentration of 0.322 mg / mL, and pass through 0.22 μm The microporous membrane, take the continued filtrate, to obtain final product;

[0074] (3) Preparation of the test solution: Take 15 tablets of Yixinshu and mix them evenly; take 1g, accurately weigh it, put it in a 25mL volumetric flask, add 20mL of methanol, and ultrasonicate for 15min; take it out, let it cool, add Methanol to the mark, ...

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Abstract

The invention discloses a method for determining the content of schisandrin in a Yixinshu traditional Chinese medicine preparation. A schisandrin reference substance is taken as a contrast, methanol and water in a ratio of (65-75):(35-25) are taken as a mobile phase, and the content of the schisandrin in the Yixinshu traditional Chinese medicine preparation is determined with a high performance liquid chromatography. The method for determining the content of the schisandrin in the Yixinshu traditional Chinese medicine preparation with the high performance liquid chromatography is high in specificity, high in precision, good in repeatability, high in recovery rate, high in stability and accurate in measurement result, so that the medicine quality is effectively controlled, the stability of the product quality as well as the safety and effectiveness of clinical medication are guaranteed.

Description

technical field [0001] The invention relates to a content determination method of schisandrin A in Yixinshu traditional Chinese medicine preparation, which belongs to the technical field of traditional Chinese medicine. Background technique [0002] Yixinshu traditional Chinese medicine preparation has the effects of replenishing qi and rejuvenating the pulse, promoting blood circulation and removing blood stasis, nourishing yin and promoting body fluid, and is often used for symptoms such as deficiency of both qi and yin, palpitations and pulse knots, chest tightness, chest pain, and angina pectoris of coronary heart disease. The prescription of Yixinshu traditional Chinese medicine preparation consists of ginseng, Ophiopogon japonicus, Schisandra chinensis, Astragalus membranaceus, Salvia miltiorrhiza, Chuanxiong, and hawthorn. [0003] Schizandrin A contained in Yixinshu traditional Chinese medicine preparation is one of the main components of Schisandra chinensis. Schisa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 张观福
Owner GUIZHOU XINBANG PHARMACEUTICAL CO LTD
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