Novel quality control method of Shuxuetong injection

Abstract

The invention relates to a quality control method of pharmaceutical preparations, and particularly relates to a novel quality control method of a Shuxuetong injection. The invention provides statistical software of high performance liquid chromatography (HPLC) separation and mass spectrum (MS) detection combined with principal component analysis (PCA), and establishes a model combining LC-MS-PCA analysis, detection and statistics of the Shuxuetong injection. The quality of the Shuxuetong injection is controlled by using the model.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicine analysis, and relates to a quality control method of traditional Chinese medicine preparations. Specifically, it adopts a liquid chromatography (HPLC) separation, performs mass spectrometry (MS) detection, and combines principal component analysis (PCA) statistical software A quality control model combining LC-MS-PCA analysis, detection and statistics of Shuxuetong injection was established, and this model was used to control the quality of Shuxuetong injection. Background technique: [0002] The composition of traditional Chinese medicine is complex, and the quality inspection standard of any component in traditional Chinese medicine cannot represent the quality standard of the whole Chinese medicine. The US FDA, the World Health Organization, and the China Food and Drug Administration have successively recognized and used Chinese medicine fingerprints to control the process stability o...

AI Technical Summary

Problems solved by technology

Although the fingerprints of traditional Chinese medicines have been generally accepted, there are still some deficiencies in practical application: First, the sources of traditional Chinese medicines are unstable, and the fingerprints of different medicinal materials have certain differences, which is not conducive to the application of fingerprints. Therefore, in the development of standard fingerprints At the same time, the source of the selected medicinal materials and the process of the finished medicine should be relatively stable, sufficiently representative, and at the same time ensure the quality, so as to ensure the advancement and representativeness of the standard fingerprint; second, the chemometric processing method for a large amount of information is not perfect enough , the characteristics of the fingerprints are not clear and specific, and the correlation between the fingerprints and the pharmacological effects is lack of research; the third is that the separation technology is not mature enough, and the single separation and detector usually used at present is difficult to completely detect the complex chemical components or active components of traditional Chinese medicine. Separation, resulting in a large amount of information loss; 4. The sensitivity is not high, and all components cannot be effectively detected; 5. The uncertainty of the fingerprint, the fingerprint of the product to be tested is compared with the standard fingerprint, and the similarity is greater than a certain value. It is a qualified product, but the difference often leads to the existence of substandard products

[0007] 3. The model of LC-MS-PCA detection and analysis technology is obtained from a large amount of statistical data after full component analysis. The tester can quickly and intuitively judge whether the product is qualified through the established model. The test result is highly accurate and subject to The source of medicinal materials has little influence; at present, Shuxuetong Injection adopts the fingerprint technology of large categories of ingredients to control the finished product, that is, amino acids, sugars and endogenous small molecules are used respectively. After that, there are still adverse reactions in clinical practice, that is, this method is still insufficient as a quality control standard.

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