Study On Digitized Fingerprints Of Raidix Scrophulariae And Qingrejiedu Injection

It is well known that the quality control (QC) of traditional Chinese medicine (TCM) is one of the key tasks of TCM modernization. Fingerprint of TCM, which is already internationally accepted as an efficient QC technique, is an integral expression of the constituents in TCM and thus can properly express their properties of complexity and interdependence. In this thesis, systemic studies on the fingerprint of Raidix Scrophulariae and Qingrejiedu injection (QRJDI) were carried out by HPLC and HPCE and the super-information characteristic digitized evaluations were presented. Methods such as blending, systematic quantified fingerprint method and the combined detection techniques of DAD-ELSD were further developed, which could be applied as new techniques for the QC of TCM.The main contents of the dissertation are as follows:(1) The index of chromatographic fingerprints (F) was used as quantitative evaluation parameter to choose the determining conditions. The HPLC digitized fingerprints of Raidix Scrophulariae under 280 nm were established and 27 common peaks were defined, taking the peak of harpagoside as referential peak. The chemical stability of common peaks was investigated by the degradation test. The qualitative similarities of crude drugs from 10 different resources were evaluated by the software of Digitized Evaluation System for Super-Information Characteristics of TCM Fingerprints 3.0. The quality of Raidix Scrophulariae was overall controlled by the systematic quantified fingerprint method which can evaluate the distribution characteristics of the chemical composition and contents.(2) The HPCE digitized fingerprints of Raidix Scrophulariae were established by CZE and the chemical stability of common peaks was investigated by the degradation test. The similarities between crude drugs and the referential fingerprint were estimated by the systematic quantified fingerprint method. The influence of some lost peaks on the double qualitative and double quantitative similarities (DQDQs) was also investigated. (3) The HPLC fingerprints of the percolate of Radix Scrophulariae and Radix Rehmannia, which is one of the intermediate of QRJDI, were established and evaluated by the software of Digitized Evaluation System for Super-Information Characteristics of TCM Fingerprints 3.0. According to the results of DQDQs, the blending technology was used to diminish the disparity in different batches.(4) The HPLC fingerprints of each single crude drug, the simulated sample and the market preparations were established under 254 nm. By using the quantified fingerprint method, we can accurately and objectively determine how high the contribution of single crude drug to the compound is, and quantitatively evaluate the process recovery of medicinal effectiveness components. It is a new feasible way to control the attribution ratio of chemical fingerprints quantitatively and optimize the technology of TCM compound.(5)According to the production process of ministry standard,10 batches of QRJDI were self-made. The fingerprints were established by the combined detection techniques of HPLC-DAD-ELSD. Through determining the quality of self-made samples and comparing them with the market preparations and the simulated sample, we can get the reason for the low content of the market preparations.