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Shenqi hypoglycemic preparation HPLC standard finger print and construction method thereof

A standard fingerprint and Shenqi hypoglycemic technology, which is applied in the detection field of Shenqi hypoglycemic preparations, can solve the problems of inability to fully reflect the type and content of chemical components, inability to fully monitor intermediates, and cumbersome detection method steps, etc., to achieve Avoid singleness and one-sidedness, good specificity, and the effect of simple methods

Active Publication Date: 2014-04-16
广东万年青制药股份有限公司
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AI Technical Summary

Problems solved by technology

[0004] The Ministry of Health of the People's Republic of China (WS 3 -180(Z-35)-95(Z)) The quality standard of Shenqi Jiangtang Tablets contained in TLC was used to separate ginsenoside Re, Rg 1 , Rb 1 The TLC spots of the reference substance and Schisandra reference medicinal materials under each specific chromatographic condition are contrast identification, and adopt TLC scanning to measure the content of ginsenoside Re. The hypoglycemic preparation contains the active ingredients of eleven medicinal materials, which cannot fully reflect the types and contents of the chemical components of the preparation, nor can it comprehensively monitor the quality of the preparation. Comprehensive and systematic testing of ingredients
②The quality of intermediates and finished products cannot be fully monitored

Method used

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  • Shenqi hypoglycemic preparation HPLC standard finger print and construction method thereof
  • Shenqi hypoglycemic preparation HPLC standard finger print and construction method thereof
  • Shenqi hypoglycemic preparation HPLC standard finger print and construction method thereof

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Embodiment 1

[0040] Shenqi hypoglycemic preparation is made from 11 medicinal materials including ginseng stem and leaf saponins, astragalus, schisandra, yam, rehmannia glutinosa, Ophiopogon japonicus, poria cocos, trichosanthes, Alisma, medlar, and raspberry. Its dosage forms include: tablets, capsules , granules and other pharmaceutical common dosage forms.

[0041] 1. Instruments and reagents

[0042] Instrument: LC-high performance liquid chromatography (DAD detector, LC-20AT pump, DGU-12A online degasser), Shimadzu Corporation of Japan; laboratory-specific ultrapure water machine, Chongqing Lidi Modern Water Technology Equipment Co., Ltd. ; CP225D Analytical Balance, Germany Sartorius Company; HWS24 Electric Heating Constant Temperature Water Bath, Shanghai Yiheng Technology Co., Ltd.; KQ-400KPE Ultrasonic Cleaner, Kunshan Ultrasonic Instrument Co., Ltd.; Chromatographic Column: Agilent ZORBAX SB-Aq (4.6×250mmi .d., 5 μm).

[0043] Test drug: reference substance

[0044]

[0045...

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Abstract

The present invention discloses a Shenqi hypoglycemic preparation HPLC standard finger print and a construction method thereof. The construction method comprises the following steps: preparing test sample solutions and a reference solution, measuring the test sample solutions and the reference solution by using the HPLC method and the linear gradient elution process, so as to obtain the Shenqi hypoglycemic preparation finger prints, wherein the chromatographic condition is that a mobile phase A is acetonitrile, a mobile phase B is 0.1% (v / v) phosphoric acid solution, the detection wavelength is 203nm, the column temperature is 25-35 DEG C and the flow rate is 0.8-1.2mL / min. The common characteristic peaks of at least ten finger prints are used as the characteristic peaks of the standard finger print; the standard finger print comprises 38 characteristic peaks, and the numbers of the characteristic peaks of saponin of ginseng stem and leaf, astragalus, Chinese magnoliaving, rehmannia root and raspberry are 13, 4, 7, 3 and 4 respectively. The Shenqi hypoglycemic preparation HPLC standard finger print and the construction method thereof can comprehensively and accurately evaluate the whole quality of the Shenqi hypoglycemic preparation, and facilitate to ensure the quality and the clinical curative effect of the Shenqi hypoglycemic preparation.

Description

technical field [0001] The present invention relates to a detection method of Shenqi hypoglycemic preparation, in particular to a construction method of HPLC standard fingerprint of Shenqi hypoglycemic preparation, and the HPLC standard fingerprint of Shenqi hypoglycemic preparation obtained by the method. Background technique [0002] Chinese medicine fingerprint refers to the spectrum of common peaks that can mark its characteristics obtained after proper processing of raw materials, decoction pieces, semi-finished products, and finished products of traditional Chinese medicine by using certain analysis methods. The fingerprint of traditional Chinese medicine can objectively reveal and reflect the integrity and characteristics of the internal quality of traditional Chinese medicine, and can be used to evaluate the authenticity, effectiveness, stability and consistency of traditional Chinese medicine. The clinical efficacy of traditional Chinese medicine is not the effect o...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 欧先涛廖娴李骁翾黄凯伟钟嘉华魏刚
Owner 广东万年青制药股份有限公司
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