A quality evaluation method for Qianliexin capsules based on the determination of multi-index active ingredients

A technology for active ingredient and quality evaluation, applied in the field of pharmaceutical testing, can solve the problems of not being able to fully reflect the multi-component and multi-target of traditional Chinese medicine prescriptions, unable to meet the quality control of finished drugs, unable to reflect the overall quality of the drug, etc. Guaranteed effectiveness and safety, the effect of more comprehensive analysis capabilities

Active Publication Date: 2020-08-04
SHANDONG ANALYSIS & TEST CENT
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  • Claims
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AI Technical Summary

Problems solved by technology

[0003] At present, the 2015 edition of "Pharmacopoeia of the People's Republic of China" (Part One) only uses thin-layer chromatography combined with reference substance paeoniflorin and reference medicinal materials Myrrha and Angelica dahurica for identification, or uses high-performance liquid chromatography to determine the content of imperatorin, The quality control index is single, which cannot fully reflect the characteristics of multi-components and multi-targets in traditional Chinese medicine prescriptions
However, the current research on the analysis and determination of the chemical components of Qianliexin Capsules only analyzes one of the components. For example, Ji Guoming et al. used HPLC to determine the content of imperatorin in Qianliexin Capsules; Lun Lijun et al. determined the content of Qianliexin Capsules by HPLC. The content of paeoniflorin in Chinese medicine, Shi Xuehong et al. also used HPLC method to determine the content of salvianolic acid B in Qianliexin capsules. As mentioned above, these studies only tested and analyzed a certain component in Qianliexin capsules. It cannot reflect the overall quality of pharmaceuticals and cannot meet the quality control of finished drugs in actual production

Method used

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  • A quality evaluation method for Qianliexin capsules based on the determination of multi-index active ingredients
  • A quality evaluation method for Qianliexin capsules based on the determination of multi-index active ingredients
  • A quality evaluation method for Qianliexin capsules based on the determination of multi-index active ingredients

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Embodiment 1

[0032] 1 Instruments and materials

[0033] Agilent 1260 high performance liquid chromatograph (autosampler, gradient pump, column thermostat, diode array detector); one hundred thousandth electronic analytical balance (SARTOURIUS BSA), fingerprint similarity evaluation software is "Chinese medicine chromatographic fingerprint Similarity Evaluation System" (National Pharmacopoeia Commission 2004A); SB-5200D high-power digitally controlled ultrasonic instrument (Ningbo Xinzhi Biotechnology Co., Ltd.).

[0034] Column: Agilent ZORBAX SB-C, USA 18 (4.6mm×250mm, 5μm), Kromasil 100-5C, Sweden 18 (4.6mm×250mm, 5μm). Gallic acid (batch number 149-91-7), chlorogenic acid (batch number 327-97-9), caffeic acid (batch number 331-39-5), Wangbuliuxing flavone glycosides (batch number 53452-16-7), iso Quercetin (lot number 482-35-9), salvianolic acid B (lot number 115939-25-8), salvianolic acid A (lot number 96574-01-5), cryptotanshinone (lot number 35825-57-1), standard The purity of the prod...

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Abstract

The invention discloses a Qianliexin capsule quality evaluation method based on multi-index active ingredient measurement. The Qianliexin capsule quality evaluation method is characterized by comprising the following steps: on the basis of an efficient liquid chromatography-electrospray time of flight mass spectrum technology, measuring eight active ingredients in the Qianliexin capsule, and constructing a Qianliexin capsule HPLC (High Performance Liquid Chromatography) fingerprint chromatogram, wherein the eight active ingredients are respectively gallic acid, chlorogenic acid, caffeic acid, vaccarin, isoquercitrin, salvianolic acid B, salvianolic acid A and cryptotanshinone. The efficient liquid chromatography-electrospray time of flight mass spectrum technology is simultaneously adopted to measure the eight active ingredients in the Qianliexin capsule and construct the Qianliexin capsule HPLC fingerprint chromatogram, and meanwhile, the Qianliexin capsule quality evaluation method is used for evaluating the quality of a Qianliexin capsule medicine, and the eight active ingredients and the chromatogram realize mutual corroboration so as to more comprehensively reflect the quality of the Qianliexin capsule medicine to be favorable for researching and guaranteeing the quality of Qianliexin capsule medicine raw materials and preparations.

Description

Technical field [0001] The invention belongs to the technical field of medical detection, and specifically relates to a quality evaluation method of Qianliexin capsules based on the determination of multiple index active ingredients. Background technique [0002] Qianliexin Capsules are included in the 2015 edition of the Pharmacopoeia of the People’s Republic of China (Part One), and are mainly composed of peach kernels (stir-fried), myrrh (stir-fried), salvia, red peony root, safflower, Eupatorium spp. It is composed of medicinal flavors such as saponaria thorn, sepsis, dandelion, Chuan neem, Angelica dahurica, Shiwei, wolfberry fruit, etc. It has the effects of promoting blood circulation, removing blood stasis, clearing heat and removing dampness, and is clinically used to treat blood stasis and coagulation caused by damp heat The symptoms of chronic prostatitis and benign prostatic hyperplasia have significant curative effect and are widely used. [0003] At present, the 2015...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/72
CPCG01N30/02G01N30/7266
Inventor 赵恒强赵志国王晓刘倩于金倩闫慧娇刘伟耿岩玲
Owner SHANDONG ANALYSIS & TEST CENT
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