Determination method of privetin in Zhenqi Fuzheng preparation

A technology of zhenqi Fuzheng and special privet glycosides is applied in the field of content determination of zhenqi Fuzheng, which can solve the problems of incomplete and inaccurate quality testing standards of Zhenqi Fuzheng preparations.

Active Publication Date: 2016-01-20
GUIZHOU XINBANG PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although "Chinese Pharmacopoeia" records the specific content determination method of privet privet glucoside, there is no record for the content determination method of privet privet in the existing Zhenqi Fuzheng preparation, Therefore, the existing quality inspection standard of Zhenqi Fuzheng preparation is incomplete and inaccurate, and it is urgent to provide a method for the determination of the content of the specific privetin component in Zhenqi Fuzheng preparation.

Method used

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  • Determination method of privetin in Zhenqi Fuzheng preparation

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Embodiment 1

[0091] Embodiment 1 of the present invention: the method for measuring the content of privetin in Zhenqi Fuzheng Capsules comprises the following steps:

[0092] (1) Chromatographic conditions and system suitability test: octadecylsilane bonded silica gel is used as filler; methanol: 0.05% phosphoric acid aqueous solution = 30:70 is used as mobile phase; column temperature is 35°C; detection wavelength is 224nm; The flow rate is 0.9mL / min; the number of theoretical plates should not be less than 4000 based on the calculation of the peak of privetin;

[0093] (2) Preparation of the reference substance solution: take an appropriate amount of the reference substance of teruci glycoside, weigh it accurately, add methanol to make a solution with a concentration of 0.2 mg / mL, and obtain it;

[0094] (3) Preparation of the test solution: Accurately weigh 3 g of Zhenqi Fuzheng preparation or its contents, accurately add 100 mL of methanol, weigh it, extract by ultrasonic or heating un...

Embodiment 2

[0096] Embodiment 2 of the present invention: the method for determining the content of privetin in Zhenqi Fuzheng Granules comprises the following steps:

[0097] (1) Chromatographic conditions and system suitability test: octadecylsilane bonded silica gel is used as filler; acetonitrile:0.05% glacial acetic acid=20:80 is used as mobile phase; column temperature is 35°C; detection wavelength is 224nm; The flow rate is 0.8mL / min; the number of theoretical plates should not be less than 4000 based on the calculation of the terucitrusin peak;

[0098] (2) Preparation of the reference substance solution: take an appropriate amount of the reference substance of teruci glycoside, weigh it accurately, add methanol to make a solution with a concentration of 0.2 mg / mL, and obtain it;

[0099] (3) Preparation of the test solution: Accurately weigh 3 g of Zhenqi Fuzheng preparation or its contents, accurately add 100 mL of methanol, weigh it, extract by ultrasonic or heating under reflu...

Embodiment 3

[0101] Embodiment 3 of the present invention: the method for determining the content of privetin in Zhenqi Fuzheng Granules comprises the following steps:

[0102] (1) Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel is used as filler; methanol:0.05% glacial acetic acid=35:65 is used as mobile phase; column temperature is 40°C; detection wavelength is 240nm; The flow rate is 1.5mL / min; the number of theoretical plates should not be less than 4000 based on the calculation of the peak of privetin;

[0103] (2) Preparation of the reference substance solution: take an appropriate amount of the reference substance of teruci glycoside, weigh it accurately, add methanol to make a solution with a concentration of 0.2 mg / mL, and obtain it;

[0104] (3) Preparation of the test solution: Accurately weigh 3 g of Zhenqi Fuzheng preparation or its contents, accurately add 100 mL of methanol, weigh it, extract by ultrasonic or reflux for 45 min, or ex...

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Abstract

The invention discloses a method for determining specnuezhenide content in a Zhenqifuzheng preparation. Taking specnuezhenide standard as contrast, the method can determine the specnuezhenide content in the Zhenqifuzheng preparation by high-performance liquid chromatography by selecting a solution containing methanol and a mixed solution with a ratio of (20-50):(80-50) or a mixed solution containing acetonitrile and the mixed solution with a ratio of (5 to 35):(95-65), wherein the mixed solution consists of water, 0.01% to 5% of phosphoric acid water solution, 0.01% to 5% of glacial acetic acid, 0.01% to 0.5% of methanoic acid water solution. Compared with the prior art, the method provided by the invention has the advantages of high specificity, high precision, high repeatability, high yield, high stability, and accurate result by adopting high-performance liquid chromatography, and can effectively control the preparation quality, thereby ensuring the stability of product quality as well as clinical safety and effectiveness.

Description

technical field [0001] The invention relates to a method for determining the content of privetin in Zhenqi Fuzheng preparation, and belongs to the technical field of quality detection of traditional Chinese medicines. Background technique [0002] Zhenqi preparations have the effects of invigorating qi and nourishing yin, strengthening the body and strengthening the foundation. Modern pharmacological experiments have proved that it can improve the immune function of the human body, protect the function of bone marrow and adrenal cortex, and promote the production of interferon; cooperate with radiotherapy and chemotherapy of tumor patients, reduce the toxic and side effects of patients during radiotherapy and chemotherapy, and promote the recovery of normal functions. Its prescription consists of Astragalus and Ligustrum lucidum. At present, the commonly used dosage forms of Zhenqi preparations for clinical selection include tablets, capsules, granules and dropping pills. ...

Claims

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Application Information

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