| Baohewan, first recorded in Danxi Xinfa, is a traditional Chinesemedical (TCM) prescription which has been used since Yuan Dynasty, which consist in8 medicinal materials such as fructus crataegi, rhizome pinelliae, poria etc. It hasextensive pharmacological effects and clinical applications, and even has many newfunctions when changing its quantity and constitution. Up till now, many researcheshave been done on the chemical constituents and pharmacological effects of its 8ingredients, but few on its quality analysis. To improve the quality evaluation system ofBaohewan, the thesis, from the quantitative and qualitative perspectives, attempts toestablish HPLC quantitative analysis method, in which oleanolic acid and ursolic acid'sranges were found to be form 0.015 to 1.232 mg·mL-1 and from 0.015 to 1.216 mg·mL-1respectively; Oxalic acid, tartaric acid, malic acid, citric acid, and succinate, 6.4×10-9,7.5×10-9, 1.2×10-8, 1.8×10-8, 2.0×10-8g respectively. The application of this method toBaohewan from some domestic manufacturers obtains satisfactory results. HPLCfingerprint spectrum is also set up to give an overoll evaluation of the qualified productsof Baohewan from 7 manufacturers, and the comprehensive information of specialty,exclusiveness and wholeness will be got. The experimental results show that themanufacturing techniques of the medicine are stable and its inner quality is uniform.Meanwhile, the fingerprint spectrum indicates the differentia of the source of rawmaterials. Thin-layer chromatography and column chromatography are used to explorethe preliminary separation of other chemical components of Baohewan. This thesisconsists of three parts.Part one deals with literature review. The history of Baohewan is investigated, andthe general introduction of researches on the chemical components of Baohewan isgiven. Documents indicate that the study of the chemical components of traditionalChinese medicines is challenging and hard. Few have studied the pharmacologicaleffects of Baohewan, and its clinical application after changing its quantity andconstitution. As methodology is concerned, HPLC and HPLC fingerprint spectrum areimportant for the application to TCM quality control mented. On the basis of others'research, the thesis analyzes and summarizes the present situation of quality study ofBaohewan and problems existing in its quality evaluation.Part two reveals the methods of quantitative analysis of Baohewan and its applications. RP-HPLC is set up to measure the quantity of oleanolic acid and ursolicacid in Baohewan. The quantity of those two organic acids from different manufacturersand varied batches of Baohewan is compared. This simple, accurate and repeatablemethod can not only make the qualitative and quantitative uniform, and controleffectively the quality of the principal drugs fructus crataegi and Forsythia, but alsoprovide reference for the quality standards of Pill of Baohe. Meanwhile, RP-HPLC isalso used to determine the quantity of five water-soluble organic acids of Baohewanwhich contribute to the absorption of food and the improvement of appetite. Satisfactoryresults are achieved from the measurement of the five organic acids in Baohewan of fivekinds from three domestic manufacturers.Part three is about the qualitative analysis of Baohewan and its application.Through the establishment of RP-HPLC fingerprint spectrum of the water-solublecomponents of Baohewan, the exclusive, macro and comprehensive information aboutits chemical characteristics can be abtained. And the overall chemical composition ofsamples is also evaluated. Thus the experimental data is provided to ensure the qualityevaluation of Baohewan and perfect its manufacturing techniques. The plant chemicalmethod is adopted to do extraction, separation, purification and identification of thechemical constituents of Baohewan. TLC is used to determine the eluting system ofcolumn separation. Through repeated experiments under the condition of 365nm UVlamp, CH3COOC2H5-C6H6-CHCl3(2:1:1) is identified as the developer. Then it is usedas the eluent of column chromatography. After a number of column chromatographyseparations, 9 compounds are finally abtained, which are proved to be singlecompounds by the test of TLC. |
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