| The injectio folii isatidis composita was prepared by Isatis indigotica Fort, Lonicera japonica Thunb, Polygonum bistorta L, Notopterygium incisum Ting ex H. T. Chang, Rheum palmatum L.. It had the effects of bacteriostasis, anti-virus etc. and was used clinically to treat influenza, acute and chronic hepatitis, epidemic parotitis. In this thesis, the quality control method of five herbs and injectio folii isatidis composita were studied for the evaluation of the injection.Firstly, the quality control method of Folium Isatidis was investigated. The water-soluble components of Folium Isatidis were studied and four compounds named cytidine, hypoxanthine, uridine, guanosine was characterized by LC/MS method by comparing the LC/MS behaviors with the standard substances. The method for determination of the four compounds was developed and used to determine the contents in different Folium Isatidis samples. The 10 batches of Folium Isatidis from Anhui Baiyunshan Pharmaceutical Corporation were evaluated. Uridine was chosen as the reference substance. 19 "common peaks" were achieved after analyzing the samples. 10 batches of samples were evaluated by "Similarity Evaluation System" for chromatographic fingerprint of TCM of the Chinese Pharmacopoeia Committee and the results showed that similarities is more than 0.95. The similarity of the FoliumIsatidis above 0.9 was considered as superior herbs.Secondly, the fingerprint of Isatis indigotica Fort, Lonicera japonica Thunb, Rheum palmatum L., Notopterygium incisum Ting ex H. T. Chang, Polygonum bistorta L were also studied. The standard fingerprints of the four herbs were developed by HPLC method. The 16, 17, 6 and 12 "common peaks" in the fingerprints for Isatis indigotica Fort, Lonicera japonica Thunb, Rheum palmatum L., Notopterygium incisum Ting ex H. T. Chang, Polygonum bistorta L, respectively. The samples were evaluated by "Similarity Evaluation System" for chromatographic fingerprint of TCM of the Chinese Pharmacopoeia Committee. The results showed that the similarity varies with the sources of the herbs and the fingerprint can be applied to the evaluation of the herbs.Thirdly, the quality control method of injectio folii isatidis composita was investigated. The determination method of the uridine, chlorogenic acid, caffeic aicd, emodin and physcion in the formulation was developed. With Uridine as reference substance, the HPLC-FP of injectio folii isatidis composita was established. There were 20 "common peaks" in the fingerprints. The similarities of the various batches of injection were analyzed by the "Similarity Evaluation System". The similarities threshold of 0.85 was set up for the samples. By comparing the fingerprints of each herb decoction, intermediate and injection, the correlation of peaks among their fingerprints were found.Finally, the pharmacokinetics and pharmacology of injectio folii isatidis composita were studied. The concentration of chlorogenic acid in rat plasma after peritoneal administration of the injection was determined by the HPLC method. The pharmacokinetics of chlorogenic acid in rats was elucidated. The antibiotics, bacteriostasis, and anti-inflammatory activities of injectio folii isatidis composita were also studied. The results indicated that injectio folii isatidis composita have antibiotics effects not only to bacterial spectrum but also to some kinds of epiphyte and strong anti-inflammatory effects. The study of the activities of folii isatidis composite provide a scientific basis for the clinical usage of the formulation.In a word, by the combination of chemical TCM, analytical chemistry, statistics and computer technology, and the application of HPLC and HPLC/MS method to the quality control of raw herbal materials of Folium Isatidis, Flos Lonicerae Radix et Rhizoma, Rhizoma et Radix notopterygii and Rhizoma Bistortae and the injectio folii isatidis composita were developed and provided a significant exploration for quality assessment of TCMs based on chromatographic fingerprint. |
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