Method for evaluating traditional Chinese medicine preparation making technology based on metabonomics technology

Abstract

The invention discloses a method for evaluating a traditional Chinese medicine preparation making technology based on a metabonomics technology, which comprises the following steps: 1, an orthogonal experiment design or a parallel contrast experiment design are used for acquiring traditional Chinese medicine preparation products with different preparation technologies; 2, the prepared products are subjected to sample pre-treatment; 3, a liquid phase series high resolution mass spectrometer is used for acquiring a chromatogram of the traditional Chinese medicine preparation product; 4, the belongingness components of the traditional Chinese medicine are found in the chromatogram according to mass loss strategy; 5, each component structure can be deducted according to fragment information obtained by determined accurate mass number and collision induced dissociation; 6, all belongingness components content in each product are subjected to quantitative analysis; and 7) the influence of the preparation technology on the preparation can be evaluated through multivariable data statistics analysis method. The method of the invention has the advantages of accuracy and sensitivity, and is not depend on standard compounds, and the change of belongingness components of the traditional Chinese medicine in the preparation product can be integrally traced.

Description

Technical field: [0001] The invention relates to the field of pharmaceutical production, in particular to the preparation process evaluation, quality evaluation and quality standard establishment of traditional Chinese medicine preparations or natural medicine preparations. Background technique: [0002] Traditional Chinese medicine preparations are developed on the basis of Chinese medicine prescriptions with good clinical application effects. They are widely used because of their multi-target and multi-effect effects, such as compound Danshen dripping pills, compound Danshen tablets, puerarin injection, step length Naoxintong, Mailuoning injection, etc. For a long time, traditional Chinese medicine preparations have played an important role in meeting clinical needs and promoting the development of Chinese medicine. However, there are also phenomena of unbalanced development, such as lack of basic research, backward preparation quality supervision system, unstable preparation q...

AI Technical Summary

Problems solved by technology

However, traditional Chinese medicine preparations, especially compound preparations, have unclear active ingredients, many impurities, unknown ingredients, and complex effects (such as hawthorn: in the preparation, the main therapeutic effect is to strengthen the stomach and eliminate food, and the content of organic acids needs to be measured; It is not reasonable to evaluate the quality of traditional Chinese medicine preparations only by the similarity of fingerprint chromatographic peaks, and it cannot support process improvement

Images