Study On HPLC Fingerprints Of Herba Eupatorii And Shegan Kangbingdu Injection

Shegan Kangbingdu Injection is a new traditional Chinese medicine injection. In this thesis, fingerprints of Herba eupatorii and Shegan Kangbingdu Injection were established by HPLC, which were evaluated by a series of qualitative and quantitative parameters. An effective method was set up to evaluate the fingerprint attribution ratio and process recovery of effective medicinal components for Shegan Kangbingdu Injection by quantified fingerprint method. And also the HPLC method was established for determination of tectoridin, iridin, irigenin and irisflorentin. This study provided new methods for overall quality control of Herba eupatorii and Shegan Kangbingdu Injection.1. The index of chromatographic fingerprints (F) was used as quantitative evaluation parameter to choose determining conditions. The HPLC digitized fingerprint of Herba eupatorii under 265 nm was established and 27 common peaks were defined, taking the peak of coumarin as referential peak. The fingerprints were comprehensively evaluated by a series of qualitative and quantitative parameters using the software of "Digitized Evaluation System for Super-information Characteristics of the Traditional Chinese Medicine Fingerprints 3.0". This study provided new methods for overall quality control of Herba eupatorii and possessed guiding significance for manufacturing traditional Chinese medicine preparation with Herba eupatorii.2. Ten batches of self-made Shegan Kangbingdu injections were prepared according to prescription technology. The HPLC fingerprint of Shegan Kangbingdu injection under 265 nm was established and 47 co-possessing peaks were selected, taking the peak of iridin as referential peak. The fingerprints were evaluated by the software of "Digitized Evaluation System for Super-information Characteristics of the Traditional Chinese Medicine Fingerprints 3.0". It is a new method for the quality control of Shegan Kangbingdu injection. 3. The chromatographic fingerprints of the simulated sample, self-prepared Shegan Kangbingdu injections, each crude drugs and Shegan Kangbingdu injections in drug market were obtained with the chromatographic conditions of Shegan Kangbingdu injection. The fingerprint attribution ratio and process recovery of effective medicinal components for Shegan Kangbingdu Injection were evaluated by quantified fingerprint method. The values of macro qualitative similarity and macro quantitative similarity showed that Rhizoma belamcandae was the monarch drug in the injection and the process recovery of the effective medicinal components for nine batches of commercial Shegan Kangbingdu injections were far lower than that of self-made preparations.4. The content determination method of tectoridin, iridin, irigenin and irisflorentin in Shegan Kangbingdu injection was established. The contents of them in self-made and commercial preparations were determined respectively. Meanwhile, it was proved that the contents of these four components in self-prepared Shegan Kangbingdu injection were much higher than that in the commercial preparations.