Quality control method for volatile components of Shenbao tablets

A quality control method and technology for volatile components, applied in the field of pharmacy, can solve the problems of no quantitative determination method and insufficient product quality evaluation, and achieve the effects of product stability, good accuracy and comprehensive product quality.

Active Publication Date: 2020-09-04
JIANGXI HUIREN PHARMA CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In the prescription process of Shenbao Tablets, volatile oils are extracted separately from Angelica, Chuanxiong, Cumin, Cnidium Fructus, Schisandra, and Atractylodes macrocephala. Among the existing standard quality control items, only Angelica, Chuanxiong, and Snake There is no quantitative determination method for the qualitative identification of bed seeds, and the evaluation of product quality is not comprehensive enough

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  • Quality control method for volatile components of Shenbao tablets
  • Quality control method for volatile components of Shenbao tablets
  • Quality control method for volatile components of Shenbao tablets

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] Embodiment 1, the screening process of the content determination of trans-anethole in Shenbao tablets

[0062] 1.1 Instruments and materials

[0063] Chromatograph: Agilent 1100 high performance liquid chromatograph;

[0064] Chromatographic column: Agilent ZORBAX SB-C18 (4.6×150 mm, 5 μm);

[0065] Reagents: absolute ethanol, ethyl acetate, n-hexane, phosphoric acid, analytically pure; methanol, chromatographically pure;

[0066] Reference substance: trans-anethole, China National Institutes for Food and Drug Control, purity 99.6%, batch number: 111835-201804.

[0067] Sample: Jiangxi Huiren Pharmaceutical Co., Ltd., batch number: 1905288.

[0068] 1.2 Choice of method

[0069] According to literature research and GC-MS research results of volatile components in Shenbao Tablets, trans-anethole from cumin and ligustilide from Ligusticum chuanxiong and Angelica sinensis were selected as index components for content determination.

[0070] Using GC chromatography, th...

Embodiment 2

[0132] The screening process of the content determination of ligustilide in embodiment 2, Shenbao tablets

[0133] 2.1 Instruments and materials

[0134] Chromatograph: gas chromatograph, Agilent 7890B; electronic thermostat electric heating mantle, model DZTW, power 0.5 KW.

[0135] Chromatographic column: Agilent HP-5, 30 m×0.32 mm×0.25 μm;

[0136] Reagents: absolute ethanol and xylene were analytically pure, Beijing Tongguang Fine Chemical Company; anhydrous sodium sulfate was analytically pure, Beijing Chemical Plant; water, prepared by Millipore clear-D ultrapure water integrated system; nitrogen, high-purity Nitrogen, 99.999% pure.

[0137] Reference substance: ligustilide, batch number MUST-19041005, purity 99.55%, Chengdu Master Biotechnology Co., Ltd.;

[0138] Sample: Shenbao Tablets, provided by Jiangxi Huiren Pharmaceutical Co., Ltd., batch number: 1905288.

[0139] 2.2 Choice of method

[0140] According to literature research and GC-MS research results of v...

Embodiment 3

[0195] Embodiment 3, the content assay method of trans-anethole

[0196] Chromatographic conditions and system suitability test Octadecylsilane bonded silica gel was used as filler; methanol-0.1% phosphoric acid water (55:45) was used as mobile phase; column temperature was 30°C; flow rate was 1.0ml / min; detection wavelength was 254 nm; the theoretical plate number should not be less than 5000 based on the trans-anethole peak,

[0197] Preparation of reference substance solution Take an appropriate amount of trans-anethole reference substance, weigh it accurately, add absolute ethanol to make a solution containing 14 μg per 1 ml, to obtain,

[0198] Preparation of the test solution Take Shenbao tablet, pulverize it with a pulverizer, take about 2 g, accurately weigh it, put it in a stoppered Erlenmeyer flask, accurately add 20 ml of absolute ethanol, seal it tightly, weigh it, and ultrasonically treat it for 30 minutes. min, let it cool, and then accurately weighed, make up f...

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Abstract

The invention relates to a quality control method for volatile components of Shenbao tablets. The invention discloses a quality control method. The method comprises the step of measuring the contentsof volatile components, namely trans-anethole and ligustilide, in the Shenbao tablet. The method comprises the following steps: (1) testing chromatographic conditions and system applicability; (2) preparation of a reference substance solution: preparing a proper amount of trans-anethole reference substance, and adding an extraction solvent to prepare the reference substance solution; (3) preparation of a test solution: crushing the Shenbao tablets, adding the extraction solvent, carrying out ultrasonic treatment, filtering the liquid, and collecting a subsequent filtrate; and (4) determination: precisely sucking the reference substance solution and the test solution respectively, injecting into a liquid chromatograph, and determining the results. The content determination method established by the invention provides a reliable way for quality control of volatile components in the Shenbao tablets, and can control the product quality more comprehensively.

Description

technical field [0001] The invention belongs to the field of pharmacy, and relates to a quality control method of traditional Chinese medicine preparations, in particular to a content determination method of volatile components in Shenbao tablets. Background technique [0002] Shenbao Tablet is a Chinese patent medicine that has been marketed, with the approval number Z20080627. Shenbao tablets are composed of epimedium, fenugreek, golden cherry, rehmannia glutinosa, psoralen, cnidium, Polygonum multiflorum, Cistanche, medlar, dodder, Schisandra, raspberry, astragalus, red ginseng, Atractylodes macrocephala, yam, Composed of twenty-two traditional Chinese medicines such as Poria cocos, angelica, Chuanxiong, fennel, plantain seed, and roasted licorice. It has the effects of reconciling yin and yang, warming yang and invigorating the kidney, and strengthening the body. It is used for soreness in the waist and legs, lack of energy, frequent urination at night, chills and fear ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 周青罡高羽沈丽琴严欢
Owner JIANGXI HUIREN PHARMA CO LTD
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