HPLC-DAD based six-ingredient rehmannia pill prescription analysis and quality analysis method

Abstract

The invention relates to a quality control method of a traditional Chinese medicine compound preparation, in particular to a prescription analysis and quality analysis method of six-ingredient rehmannia pill based on a high performance liquid chromatography-diode array detection technology (HPLC-DAD). The method comprises the following two parts: firstly, respectively identifying the characteristic peaks of six prescription decoction pieces in a plurality of wavelength modes by utilizing the difference of ultraviolet absorption spectra of chemical components of the six decoction pieces in the six-ingredient rehmannia pill, and establishing a six-ingredient rehmannia pill prescription analysis method based on the characteristic peaks of the decoction pieces; and secondly, developing a quality marker (Q-Marker) of the six-ingredient decoction pieces on the basis of the characteristic peaks of the decoction pieces, and analyzing the current quality situation of the six decoction pieces in the six-ingredient rehmannia pill by using the Q-Marker. The prescription analysis and quality analysis method provided by the invention is simple and efficient, and lays a scientific foundation for the overall quality control of the six-ingredient rehmannia pill.

Description

technical field [0001] The invention belongs to the field of quality control of traditional Chinese medicine compound preparations, and relates to a quality control method of the compound preparation Liuwei Dihuang Pills, specifically the analysis and quality of Liuwei Dihuang Pills based on high-performance liquid chromatography-diode array detection (HPLC-DAD) technology Analytical method. Background technique [0002] Traditional Chinese medicine compound preparations have unique curative effects, embody the holistic view and syndrome differentiation and treatment in the essence of Chinese medicine theory, and are the main forms and means of clinical medicine in Chinese medicine formed in long-term medical practice. , Traditional Chinese medicine compound preparations are usually composed of a variety of medicinal materials, which produce multi-component, multi-target, and multi-channel overall comprehensive regulatory therapeutic effects on the body. However, this combi...

AI Technical Summary

Problems solved by technology

However, distinguishing the microscopic characteristics of different medicinal materials requires considerable experience accumulation, and TLC needs to use different processing methods and solvent systems for different identification objects, the operation is cumbersome and time-consuming, and the accuracy of TLC is not high and lacks certain specificity; HPLC operation Simple, excellent separation effect and good repeatability, the fingerprint method based on HPLC has been more and more widely used in the field of quality control of traditional Chinese medicine preparations

At present, the research on the fingerprints of Liuwei Dihuang Pills mainly includes similarity analysis, and combined with mass spectrometry, ELSD, DAD and other detection technologies to conduct qualitative and multi-index components quantitative research on the main active ingredients of Liuwei Dihuang Pills [Xie B, Gong T, Tang M, et al.Journal of Pharmaceutical and Biomedical Analysis,2008,48(4):1261-1266.; Yan B,Sun G.Journal of Separation Science,2017,41(6).;Qiu Y,Huang J,Jiang X, et al. Journal of Separation Science, 2015, 38(21): 3720-3726.; Ye J, Zhang X, Dai W, et al. J Pharm Biomed Anal, 2009, 49(3): 638-645. ], failed to analyze and belong to the six prescription decoction pieces in Liuwei Dihuang Pills from the overall level, and it is difficult to truly analyze the quality difference of Liuwei Dihuang Pills from different manufacturers

At the same time, the quantification of multi-index components greatly increases the difficulty of obtaining reference substances, the cost and the cumbersomeness of the method

[0005] Chen et al. used micro-infrared spectroscopy to develop an identification method for Liuwei Dihuang Pills prescription based on attenuated total reflection infrared spectroscopy imaging, and realized the simultaneous identification of six decoction pieces in Liuwei Dihuang Pills [Chen J B, Sun S Q, ZhouQ.Analytical and Bioanalytical Chemistry, 2014, 406(18): 4513-4525.]; Bai and Cheng et al. used metagenomics methods to extract and amplify the DNA and compare it with the database to realize the identification of the prescription pieces [Bai H , Li X, Li H, et al.Scientific reports, 2019,9(1):5853.; Cheng X, Su X, ChenX, et al.Scientific Reports, 2014,4(1):5147.], the above Micro-infrared technology has high requirements for instruments and equipment, and DNA extraction and analysis operations are difficult and costly

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