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Method for performing limit test on aristolochic acid A in Zhuifengtougu capsule

A technique of aristolochic acid and inspection method, applied in the field of medicine, can solve the problems of misjudgment, weak specificity, affecting product quality control, etc.

Inactive Publication Date: 2018-05-04
HINYE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] When our company used the above-mentioned standard method to detect the negative sample of Asarum in Zhuifeng Tougu Capsules without Aristolochic Acid A, it was found that there was interference from the peak position of the Aristolochic Acid A reference substance, which made the specificity of the method not strong , may lead to misjudgment and affect the quality control of this product

Method used

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  • Method for performing limit test on aristolochic acid A in Zhuifengtougu capsule
  • Method for performing limit test on aristolochic acid A in Zhuifengtougu capsule
  • Method for performing limit test on aristolochic acid A in Zhuifengtougu capsule

Examples

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Effect test

Embodiment 1

[0029] Example 1: Examination of the specificity of the limit of aristolochic acid A in Zhuifeng Tougu capsules by using the method of the present invention.

[0030] 1 Chromatographic conditions.

[0031] Mobile phase: mobile phase A: 0.5% glacial acetic acid solution mobile phase B: methanol.

[0032] Chromatographic column: Waters symmetry C18 5 μm 250mm×4.6mm.

[0033] Detection wavelength: 250nm.

[0034] Flow rate: 1ml / min.

[0035] Injection volume: 5 μl.

[0036] Workstation: ChemStation for LC systems.

[0037] The gradient elution procedure is as follows.

[0038]

[0039] 2 Instruments and reagents.

[0040] Liquid chromatograph: Agilent 1260 high performance liquid chromatograph.

[0041] Analytical balance: Mettler Toledo New Classic MS electronic analytical balance.

[0042] Methanol: chromatography pure, Sigma Reagent Company.

[0043] Glacial acetic acid: Hunan Huihong Reagent Co., Ltd.

[0044] Aristolochic acid A reference substance: batch number...

Embodiment 2

[0058] Example 2: A durability study of checking the limit of aristolochic acid A in Zhuifeng Tougu capsules by using the method of the present invention.

[0059] 1 flow rate.

[0060] Other chromatographic conditions except the flow rate are the same as in Example 1, and the instruments and reagents are the same as in Example 1. The flow rates for this study were 0.9 ml / min, 1.0 ml / min and 1.2 ml / min.

[0061] 1.1 Solution preparation.

[0062] Reference substance solution: Accurately weigh 5.20mg of aristolochic acid A reference substance, put it in a 100ml measuring bottle, add methanol to dissolve and dilute to the mark, shake well, accurately measure 2ml, put it in a 50ml measuring bottle, add methanol to dilute to the mark , shake well, and serve.

[0063] Preparation of the test solution: Take the content of this product, grind it finely, take 5.0092g, accurately weigh it, put it in a stoppered Erlenmeyer flask, add 50ml of methanol, heat and reflux for 2 hours, let...

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Abstract

The invention discloses a method for performing limit test on aristolochic acid A in a Zhuifengtougu capsule and belongs to a high performance liquid chromatography method. According to the method, 0.5 percent glacial acetic acid and methanol serve as flowing phase and are subjected to gradient elution. By adoption of the method, impurity peak interference at the peak position of an aristolochic acid A control product can be eliminated, the specificity is more excellent than that of the existing method, the durability is high, quality control can be realized well and the medicine safety is benefited.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a method for quality control of aristolochic acid A in Zhuifeng Tougu capsule, a compound traditional Chinese medicine preparation. Background technique [0002] Aristolochic acid is a toxic component that may be contained in Chinese herbal medicines derived from Aristolochiaceae plants. Aristolochic acid has obvious nephrotoxicity, which can damage the function of renal tubules and even cause the risk of kidney cancer. Therefore, in order to ensure the safety and effectiveness of clinical medication, strict testing must be carried out for Chinese medicines that may contain aristolochic acid, and limits must be established. [0003] Aristolochic acid is a class of nitrophenanthrene compounds, including aristolochic acids A, B, C and D. Studies have shown that the toxicity of aristolochic acid compounds is mainly caused by aristolochic acid A or its metabolite aristolactam. Therefore, wh...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 宋志林程雪清张海霞
Owner HINYE PHARM CO LTD
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