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Guanxinshutong capsule content detection method using quantitative analysis of multi-components by single-marker

A detection method, the technology of Guanxinshu, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of complex and cumbersome operation, large consumption of reference substances, shortage of supply, etc., and achieve strong operability and good recovery rate Effect

Active Publication Date: 2017-07-14
SHAANXI BUCHANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In order to ensure the clinical efficacy of the drug, the multi-component content determination method can effectively monitor the component content of Guanxinshutong Capsules to ensure the quality of the preparation, but this method (external standard method) has a large consumption of reference substances and many types of reference substances , the defect of complicated and tedious operation, and the preparation method of some reference substances is complicated, and the supply is in short supply, which limits the application of this method in scientific research, actual production and market supervision

Method used

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  • Guanxinshutong capsule content detection method using quantitative analysis of multi-components by single-marker

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Embodiment 1

[0048] Embodiment 1: The present invention establishes a test and multiple evaluation method to measure Guanxinshutong capsule liquid chromatography method

[0049] 1 Instruments and reagents

[0050] 1.1 Instrument

[0051] Agilent 1260 (quaternary pump G1311B; autosampler G1329B; column thermostat G1316A; diode array detector G4212B; LAB open chromatography data workstation); electronic analytical balance (model BP211D, d = 0.01mg, German Sartorius balance limited company); ultrasonic cleaner (model: KQ-250DE, Kunshan Ultrasonic Instrument Co., Ltd.); Agilent ZORBAX Extend-C 18 Chromatography column (250mm×4.6mm, 5μm).

[0052] 1.2 Reagent

[0053] The 24 batches of Guanxin Shutong Capsules were all produced by Shaanxi Buchang Pharmaceutical Co., Ltd., and the batch numbers are shown in Table 2. Methanol was chromatographically pure (Fisher Reagent Company, USA), water was Wahaha Water (Hangzhou Wahaha Group Co., Ltd.), and other reagents were analytically pure.

[0054...

Embodiment 2

[0110] Study on the Influencing Factors of Relative Correction Factor and Relative Retention Time

[0111] Influencing factors such as different brands of chromatographic columns were investigated respectively. Take 10 μl of the reference substance solutions of the five groups under the reference substance preparation item, inject them into high-performance liquid chromatography for analysis, and investigate the influence of the above factors on the correction factor and relative retention time.

[0112] 2.1 Method reproducibility inspection

[0113] The experiment investigated the reproducibility of relative retention time and retention time difference in different chromatographic columns. The chromatographic columns are: Kromasil C 18 Chromatographic column (4.6mm×250mm, 5μm), Diamonsil C 18 Chromatography column (4.6mm×250mm, 5μm), Agilent Extend-C 18 Chromatographic column (4.6mm×250mm, 5μm), the result |RSD| of the retention time difference and the relative retention ...

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Abstract

The invention provides a Guanxinshutong capsule content detection method using quantitative analysis of multi-components by single-marker (QAMS). According to the present invention, the chromatographic conditions comprise that the chromatographic column uses an octadecyl-bonded silica gel column as a filler, methanol is adopted as a mobile phase A, a 0.4% formic acid aqueous solution is adopted as a mobile phase B, a volume ratio of the mobile phase A to the mobile phase B is 3-90:97-10, linear gradient elution is performed, the detection wavelength is 280 nm, the column temperature is 35 DEG C, and the sample injection volume is 5 [mu]L; the content detection method can simultaneously determine the contents of gallic acid, danshensu sodium, protocatechuic acid, protocatechuic aldehyde, vanillin, rosmarinic acid, salvianolic acid B, eugenol, cryptotanshinone and tanshinone IIA in the Guanxinshutong capsule; and the detection method has characteristics of simpleness, accuracy, efficiency, good reproducibility, and good stability.

Description

technical field [0001] The invention belongs to the field of chemical analysis and detection of Chinese patent medicines, in particular to a method for detecting the content of Guanxinshutong capsules through one measurement and multiple evaluations. Background technique [0002] Guanxinshutong Capsules are exclusively produced by Shaanxi Buchang Pharmaceutical Co., Ltd. The current national drug standard number is WS3-155(Z-025)-2005(Z). It has outstanding curative effect in the treatment of coronary heart disease. The preparation is a new medicine developed on the basis of the theory of Mongolian medicine. It is prepared from five herbs including jujube, salvia miltiorrhiza, clove, borneol, and Tianzhuhuang. , for the treatment of coronary heart disease, angina pectoris and other diseases caused by chest obstruction, heart and blood stasis. [0003] In order to ensure the safety and effectiveness of compound preparations, the methods and means of quality control of compou...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 刘峰李晔杨东花王春柳龙凯花黄壮壮张红
Owner SHAANXI BUCHANG PHARMA
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