Study On The Quality Evaluation Of Salvia Miltiorrhiza And Its Injection (Lyophilized Powder)

In recent years, increasing emphasis on quality control of Traditional Chinese Medicine(TMC) and its preparation. With the improvement of the modern analytical techniques and the progress of computer application technology, the characteristic components and comprehensive analysis of the fingerprint has become recognized as the TMC quality control mode. Fingerprinting technology based on the chemical composition and pharmacological studies, reflected three basic principles,reproducibility、systematic and characteristic. It can provide a full range of assurance from the cultivation of the crude drugs, proprietary TMC production processes optimization and standardize to the formulation of preparation quality standards. With the in-depth study of the world on natural medicine, fingerprinting technology become the most effective method for the control of TMC and natural crude drug.The study on fingerprinting in China is not perfect, its establish the fingerprint of TMC and preparation, digital process relevant information, so it can control the quality of TMC and preparation. Currently the study on fingerprint in abroad is establishment fingerprint and efficacy for new drug development.The first chapter introduces the active ingredient in Salvia miltiorrhiza and its preparations, pharmacological activity and fingerprint progress.The second chapter study on the best extraction process of Salvia miltiorrhiza water-soluble and fat-soluble ingredients by single factor experiments and orthogonal test. The detecting wave length was at280nm and the mobile phase consisted of methanol-0.2%phosphoric acid with a gradient elution.Used the HPLC method for simultaneous determination eleven kinds of active ingredient in Salvia miltiorrhiza. Using the principal component analysis and cluster analysis of the SPSS software for data.develop Shandong Salvia miltiorrhiza fingerprint. The results showed that there is no significant difference in10batches of Salvia miltiorrhiza and can successfully mapped the Shandong Salvia miltiorrhiza fingerprint, in line with national requirements similarity above0.98.To achieve a rapid and comprehensive quality control of Salvia miltiorrhiza..Chapter three study on the Salvia lyophilized water-soluble components were measured using high performance liquid chromatography, drawn28batches of freeze-dried powder fingerprint. It was found method that can simultaneous determination eight kinds of active ingredient in Salvia miltiorrhiz lyophilized powder, fingerprint similarity were above0.95, in line with national requirements for traditional Chinese medicine injections. To achieve a comprehensive, rapid and effective evaluation of Salvia miltiorrhiz Lyophilized quality control mode.