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A method for determining the content of formononetin in Zhenqi Fuzheng preparation

A technique for zhenqi fuzheng and formononetin, which is applied in the field of content determination of formononetin in zhenqi fuzheng preparation, and can solve problems such as the content determination of formononetin

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

[0004] However, the existing quality inspection method of Zhenqi Fuzheng preparation does not measure the content of formononetin. The content determination project of formononetin is very necessary

Method used

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  • A method for determining the content of formononetin in Zhenqi Fuzheng preparation
  • A method for determining the content of formononetin in Zhenqi Fuzheng preparation
  • A method for determining the content of formononetin in Zhenqi Fuzheng preparation

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Embodiment 1

[0076] Embodiment 1 of the present invention: the content determination method of formononetin in a kind of Zhenqi Fuzheng preparation is as follows:

[0077] (1) Chromatographic conditions and system suitability test: octadecylsilane bonded silica gel is used as filler; acetonitrile: 0.5% phosphoric acid aqueous solution = 40:60 is used as mobile phase; the detection wavelength is 254nm, and the flow rate is 1.0mL / min , the column temperature is 35°C; the number of theoretical plates calculated based on the peak of formononetin should not be less than 5000;

[0078] (2) Preparation of reference substance solution: Take an appropriate amount of formononetin reference substance, weigh it accurately, add methanol to make 1mL solution containing 0.1mg, and set aside;

[0079] (3) Preparation of the test solution: Accurately weigh 2.0 g of Zhenqi Fuzheng preparation or its contents, accurately add 100 mL of 70% ethanol, weigh, extract by ultrasonic for 1 hour, make up the weight w...

Embodiment 2

[0081] Embodiment 2 of the present invention: the content determination method of formononetin in a kind of Zhenqi Fuzheng preparation is as follows:

[0082] (1) Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel is used as filler; acetonitrile: water = 40:60 is used as mobile phase; detection wavelength is 254nm, flow rate is 1.0mL / min, column temperature at 35°C; the number of theoretical plates calculated based on the formononetin peak should not be less than 5000;

[0083] (2) Preparation of reference substance solution: Take an appropriate amount of formononetin reference substance, weigh it accurately, add methanol to make 1mL solution containing 0.1mg, and set aside;

[0084] (3) Preparation of the test solution: Accurately weigh 2.0 g of Zhenqi Fuzheng preparation or its contents, accurately add 100 mL of methanol, weigh, extract by ultrasonic or reflux for 1 hour, make up the weight with methanol, and filter; Continuing with 50...

Embodiment 3

[0086] Embodiment 3 of the present invention: a method for determining the content of formononetin in Zhenqi Fuzheng preparation is as follows:

[0087] (1) Chromatographic conditions and system suitability test: octadecylsilane bonded silica gel is used as filler; methanol:0.05% glacial acetic acid=60:40 is used as mobile phase; column temperature is 40°C; detection wavelength is 270nm; The flow rate is 1.5mL min -1 ; The number of theoretical plates should not be less than 5000 based on the peak of formononetin;

[0088] (2) Preparation of reference substance solution: Take an appropriate amount of formononetin reference substance, weigh it accurately, add methanol to make 1mL solution containing 0.1mg, and set aside;

[0089] (3) Preparation of the test solution: Accurately weigh 2.0 g of Zhenqi Fuzheng preparation or its contents, accurately add 100 mL of methanol, weigh, extract by ultrasonic or reflux for 1 hour, make up the weight with methanol, and filter; Continuing...

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Abstract

The invention discloses a method for measuring content of formononetin in a Zhenqifuzheng preparation. The method is a high-performance liquid chromatography with a formononetin reference substance used as a contrast and the ratio of methyl alcohol to water / a 0.01%-5% phosphoric acid aqueous solution / a 0.01%-5% glacial acetic acid / a 0.01%-0.5% formic acid aqueous solution of (50-70):(50-30) or the ratio of acetonitrile to the water / the 0.01%-5% phosphoric acid aqueous solution / the 0.01%-5% glacial acetic acid / the 0.01%-0.5% formic acid aqueous solution of (20-50):(80-50) used as a mobile phase. The method is high in specificity, high in accuracy, good in repeatability, high in recovery rate, high in stability, accurate in measurement result and capable of achieving the purpose of effective control of the drug quality and ensuring the stability of the product quality and the safety and the effectiveness of clinical medication.

Description

technical field [0001] The invention relates to a method for determining the content of formononetin in Zhenqi Fuzheng preparation, which belongs to the technical field of traditional Chinese medicine quality detection. 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 dosage forms of Zhenqi preparation for clinical selection include tablets, capsules, granules and dropping pills. [0003] The ...

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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