To reveal of chemical and efficacy substance of traditional Chinese medicines (TCMs) is one of kernel parts in the studies on TCMs and is the key to modernize the TCMs industry as well. It is of great importance for the discovery of the biologically active constituents in TCMs and for constructing scientific quality control standards of Chinese patent drugs, which consequently would propel the development of the TCMs science and the internationalization of TCMs industry. In this dissertation, the HPLC/ESI-MS based methodologies of studies on chemical and efficacy substance of some TCMs formulae were successfully constructed.Studies on the chemical substance of traditional Chinese patent drugs formulae using HPLC/ ESI-MS were firstly carried out. "Shenmai injection", "Danshen dripping pill" and "Si-wu decoction" were selected for studies in terms of different complexity of their formulae. By HPLC/ESI-MS analyses, the major constituents in these three drugs were successfully revealed for the first time and the results would facilitate the improvement of their quality control standards.Through the study on "Shenmai injection", a total of 39 ginsenosides were indentified. It indicates that Panax ginseng is the primary crude drug that determines the quality of "Shenmai injection" rather than Ophiopgon japonicus. Furthermore, the separation of these ginsenosides was performed with porus resin material. As a result, a good performance of separtion was obtained, which demonstrated porus resin material is suitable for separating the constituents of large polarity in TCMs.During the study on "Danshen dripping pill", a pre-treating method basing upon solid-phase extract (SPE) technique was firstly built to separate phenolic acids from Salvia miltiorrhizae and saponins from Panax notoginseng. Prior to the HPLC/ESI-MS analysis, the studies on the fragmentation behavior of authentic chemicals of salvianolic acids and ginsenosides were performed to find out the fragmentation pattern of either compound. On this basis, a total of 10 phenolic acids, along with two tanshinones, from Salvia miltiorrhizae and 21 saponins from Panax notoginseng, including a few of novel compounds, were identified.In the study of "Si-wu decoction", HPLC/ESI-MS analyses of "Si-wu decoction" and its crude drugs' extracts were firstly performed to find out which crude drug each component belongs to. It largely simplified the identification work and a total of 13 major constituents, including phenolic acid, phthalide, iridoid glycoside, and so forth, were characterized. Benzoic acid, a common preservative, was detected at a high concentration. An HPLC quantitative method with good repeatability (RSD.38 %) and recovery (96.64%~105.21%) was then successfully established to simultaneouslydetermine seven of these constituents.On the basis of the study on "Shenmai injection", HPLC/MS was employed to differentiate the saponin extracts of Panax ginseng, Panax notoginseng and Panax quinquefolius and a total of 32 saponins were unequivocally or tentatively identified. By compaing their compositions, mark compounds of each extract were founded. The results demonstrated that HPLC/MS could be well applied for the differentiation and authentication of the saponin extracts of Panax ginseng, Panax notoginseng and Panax quinquefolius.The studies described above exhibited an excellent ability of HPLC/ESI-MS for simultaneous qualitative and quantitative analysis of complex TCMs formulae. The advantages of HPLC/ESI-MS involving high efficency, rapidness, low request on sample quantity, and so forth, enable this analytical technique to be well applied for quality control studies on TCMs. A methodological guide was also provided for studies on the influences of various extracting parameters and the compatibility on the extraction of traditional Chinese crude drugsIn order to find out how the extracting conditions affect the chemical compositions of the extracts of traditional Chinese crude drugs and to guarantee the consistences of batches of TCMs products, the...
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