| Saussurea involucrata (Kar.et Kir.)Sch. - Bip.Linnaea. is a kind of folk medicine, possessing wide pharmacological activities. With the development of modern pharmacology study and clinic applications of its cure for rheumatic arthritis and rheumatoid arthritis and other activities, Saussurea involucrata ( Kar.et Kir.)Sch. -Bip.Linnaea. increasingly attracts the attention of pharmaceutical researchers all over the world. The purpose of this thesis is to develop methods for the quality control of Saussurea involucrata (Kar.et Kir.)Sch. - Bip.Linnaea. and its injection. An active constituent, chlorogenic acid, was isolated from Saussurea involucrata (Kar.et Kir.)Sch. -Bip.Linnaea. and identified by using UV, MS, 1H-NMR and 13C-NMR. High performance liquid chromatography fingerprint spectrum (HPLC-FPS) was developed for identification and quality evaluation of Saussurea involucrata (Kar.et Kir.)Sch. - Bip.Linnaea., the injection and its intermediate. The contents of chlorogenic acid and rutin in raw materials of Saussurea involucrata ( Kar.et Kir.)Sch. - Bip.Linnaea. from different sources were simultaneously determined. HPLC method for determination of chlorogenic acid, rutin and syringin in xuelian injection and its intermediate was developed.1. Isolation of chlorogenic acidActive constituents presenting in Saussurea involucrata ( Kar.et Kir.JSch. -Bip.Linnaea. include flavonoids, alkaloids, lignans and volatile oils. Chlorogenic acid is one of organic acids exhibiting anti-inflammatory and antipyretic activity. Its isolation from Saussurea involucrata (Kar.et Kir.)Sch. - Bip.Linnaea. and structure elucidation are reported in the paper. 2. Development of method for quality control of Saussurea involucrata (Kar.et Kir.)Sch.- Bip.Linnaea..With syringin as reference substance, an HPLC-FPS that can indicate substances existing in Saussurea involucrata (Karet Kir.)Sch.-Bip.Linnaea. was established with a BDS-C18 column, ultraviolet detection and CH3CN—50mmol·L-1KH2PO4 (pH3.6) as mobile phase for gradient elution. The method showed a satisfactory reproducibility. Analyzed by Computer Aided Similarity Evaluation System, the HPLC-FPS similarities of Saussurea involucrata (Kar.et Kir.)Sch. -Bip.Linnaea. of 21 batches were over 0.95.Rutin is an effective constituent of Saussurea involucrata (Kar.et Kir.)Sch.-Bip.Linnaea.. An RP-HPLC method was developed for simultaneous determination of chlorogenic acid and rutin in Saussurea involucrata (Kar.et Kir.)Sch.-Bip.Linnaea., and samples of 21 different batches were determined. The total flavonoid is the main effective constituent of Saussurea involucrata (Kar.et Kir.)Sch.-Bip.Linnaea.. The flavonoids in Saussurea involucrata (Kar.et Kir.)Sch.-Bip.Linnaea. was determined by UV spectrophotometry. The determination of flavonoids in Saussurea involucrata (Kar.et Kir.)Sch.-Bip.Linnaea. would be useful to the quality control of xuelian injection.3. Development of method for quality control of xuelian injectionUnder the same chromatography condition as in HPLC-FPS of Saussurea involucrata (Kar.et Kir.)Sch.-Bip.Linnaea., fingerprints of the intermediate and injection were determined. Syringin was choosed as the reference substance, 19 common peaks were achieved after analyzing 10 batches of the injection samples, and HPLC-FPS common pattern of the injection was developed. The similarities of 10 batches of injection samples were all over 0.90. There is a good correaltionship among injection, intermediate and Saussurea involucrata (Kar.et Kir.)Sch. -Bip.Linnaea.. The method offers guarantee for the stability of the preparation technics and final products of xuelian injection.An RP-HPLC method was developed in this paper for the determination of chlorogenic acid,rutin and syringin in the injection for the first time. This method is simple, accurate and robust. The flavonoid in xuelian injection was determined by UV spectrophotometry. |