Study On Chemical Fingerprinting And Quality Control Of Xinkeshu Tablet

The quality control (QC) of Traditional Chinese medicine (TCM) is one of the key issues of TCM modernization. Chemical fingerprinting of TCM, Which is already internationally accepted as an efficient QC strategy to integral express the consistent in TCM, can properly express their properties of complexity and interdependence. High performance liquid chromatography/mass spectrometry (HPLC/MS) technologies, for its powerful capability of separation, identification and quantitative determination, has been widely used in characterizing the chemical composition and monitoring the content changes of in complex TCM system. HPLC/MS has become an indispensable analytical tool in the study on chemical constituents of TCMs. In addition, the development of near infrared spectroscopy (NIRS), provide an effective and rapid quality analysis method for the control of TCM pharmaceutical process.In this study, the method and technology of chemical fingerprinting was applied to the quality control of Xinkeshu tablet (XKS). A HPLC/MS method was proposed in the studies on the chemical analysis of XKS. A method based on NIRS was applied on one of the critical manufacturing process of XKS.The main content and academic contributions of this paper are as follows:(1) According to the ideas of overall characterization of TCM preparations, take XKS as the object of this study. A Chemical fingerprinting based of HPLC/DAD was established for the overall characterization of XKS.(2) A HPLC/DAD/ESI/MS" method was constructed to reveal the chemical substance in XKS, all of the herbal peaks were assigned, by comparing the retention time, UV absorption wavelength and MS information with standard compounds information and literature data, a total of27compounds were successfully identified.(3) A method based on HPLC/DAD was established to simultaneously quantification of3salvia miltiorrhiza water-soluble ingredients,3puerarin isoflavones and4saponins.(4) A method based NIRS had been used to on-line measure the content of key compound of of Radix Puerariae and Hawthorn extracting process, and a partial least square regression (PLSR) model had been developed to rapid quantify the content of multiple ingredients in the extract solution of Radix Puerariae and Hawthorn extract. The on-line measure results of the proposed model were precisely close to the real content of the key compounds. A fast method based on NIRS for on-line end point determination for Radix Puerariae and Hawthorn extraction process was also developed. The result showed the proposed method is fast, accurate and applicable for the extraction process of Radix Puerariae and Hawthorn.Through the research of the present work, a systemic quality control method was established for XKS. The results of these studies would be helpful to discover the biologically active compounds and provided valuable information for the development and improvement of the quality control of XKS.