Construction method for compound thrombus clearing preparation bioactivity chromatography finger print

Abstract

The present invention discloses a construction method for a compound thrombus clearing preparation bioactivity chromatography finger print. The construction method comprises the following steps: (1) preparing a compound thrombus clearing preparation test solution, precisely sucking 10 mul of the compound thrombus clearing preparation test solution, and injecting into a double-pump dual-gradient high performance liquid chromatograph to obtain a compound thrombus clearing preparation HPLC finger print; (2) preparing a mixed reference substance solution, precisely sucking 10 mul of the reference substance solution, and injecting into the double-pump dual-gradient high performance liquid chromatograph to obtain a reference substance HPLC finger print; (3) adopting a reference substance control method, and adopting an RRLC / MS / MS technical method to prove 21 chemical components in the finger print; and (4) analyzing correlation between the 21 chemical components and bioactivity difference, clarifying bioactivity component groups, and establishing a compound thrombus clearing preparation bioactivity chromatography finger print. According to the present invention, the compound thrombus clearing preparation HPLC finger print and the bioactivity component groups obtained from chromatograph efficiency analysis are combined to construct the compound thrombus clearing preparation bioactivity chromatography finger print so as to completely monitor safeties, effectiveness and quality uniformities of raw material herbs, semi-finished products and finished products.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for constructing a biologically active chromatographic fingerprint of a compound Xueshuantong preparation. Background technique [0002] Since my country's SFDA put forward the requirement of establishing fingerprints for traditional Chinese medicine injections in 2000, by 2010, there were 14 kinds of fingerprints of relevant medicinal materials specified in the Chinese Pharmacopoeia, and 7 kinds of characteristic maps. Fingerprints are more and more widely used in my country. It plays a pivotal role in promoting the internationalization of Chinese medicine quality standards and accelerating the process of modernization of Chinese medicine. With the rapid development of modern analytical techniques, it will be one of the development trends of traditional Chinese medicine fingerprint technology to reflect the chemical information of traditional Chinese medicine more ...

AI Technical Summary

Problems solved by technology

The shortcomings of this technical solution are: (1) The pharmacodynamic index is single, only the viscosity of whole blood, which cannot fully reflect the clinical efficacy of the drug

(2) The selected pharmacodynamic experimental animal model is used to simulate the clinical yin deficiency state, which is mainly reflected in the growth status, cyclic nucleotide system, endocrine system, immune system and substance metabolism level, etc. Curative effect does not quite match

(3) Fingerprint information and drug efficacy information are only associated with multiple regression analysis methods, the method is single and one-sided, and the calculation results are not convincing

The disadvantages of this fingerprint method are: (1) The preparation method of the test sample is cumbersome and costly, and the water rinsing step of the solid phase extraction (SPE) column leads to the loss of water-soluble components

(2) Using a conventional chromatographic column with a length of 250 mm requires a long analysis time and consumes a lot of mobile phase

(3) The chemical information and chemical explanations provided by the fingerprints are limited. On the basis of simultaneous monitoring of the four medicinal materials, only the fat-soluble quinone components of Danshen were detected, but the water-soluble phenolic acid components were not detected, and Content not confirmed by mass spectrometry

(4) The biological activity of the chemical components corresponding to each chromatographic peak in the fingerprint is unclear, and the content of active ingredients in Fufang Xueshuantong Capsules cannot be effectively monitored, and the safety and effectiveness of the product cannot be guaranteed

[0006] To sum up, the existing methods for constructing fingerprints of Fufang Xueshuantong Capsules have many shortcomings. On the basis of further improving its fingerprinting technology, it is necessary to pay more attention to the bioactive components in it.

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