Study On The Quality Evaluation Of Danshen Injection

Danshen injection is a common used traditional Chinese medicine injection, which is produced from Radix et Rhizoma Salviae Miltiorrhizae by several preparation process. The instructions of Danshen injection indicate that it can impove the blood circulational condition, clear the blood vessels and benefit the cardiovascular system. In resent years, more broadly clinical applications have been found and applicated for fighting with many other disease. For instance, Liver disease, nephritis, acute kidney injury, asthma, etc.To establish a more effective and complete quality standard for Danshen injection and control the internal quality of this preparation thoroughly, several reseachs which were targeted to the confusions and problems I found had done in this work. The confusions and problems mentioned above were based on the feedback from the questionnaires and the results of statistical analysis on the standard test data.The first chapter introduced the history of development of Danshen injection and its basic information such as indications, adverse effect, etc. The second chapter made a brief introducton of the current national standard and research progress of the preparation. The third chapter discripted the existing problems that based on the feedback from the questionnaires and the results of statistical analysis on the standard test data. The fourth chapter was the main chapter. In this chapter, the proposes, the methods, the results and the conclusions of4studies were discussed in detail one by one. The1st study established a HPLC method for simultaneous measurement of multi-component (sodium danshensu, protocatechuic acid, protocatechuic aldehyde, vanilla acid, ferulic acid, rosmarinic acid, salvianolic acid B) with single marker in Danshen injection. Seven main ingredients were evaluated and their relative correlation factors (RCF) were determined by HPLC-UV. The2nd study established the fingerprints of Danshen injection by HPLC method.16common peaks were found in the fingerprints of Danshen injection. The3rd study established an HPLC method to determine the content of5-(Hydroxymethy1)-2-furfural(5-HMF) in Danshen injection. The4th study researched on the changes of phenolic substances during the process of production of Danshen injection. Forther more, data from other reseach were quoted to analysis the correlations between the multi-component. The5th reseach briefly introduced the methods of determinating the Tween80and the antioxidants. Further discussions of the rationality of using these auxiliary materials in Danshen injection by statistical analysis were made in this chapter. The fifth chapter summarized the resluts of the researchs, formulate a draft standard for Danshen injection based on this research and made an outlook of the development of both the Danshen injecton and its national quality standard.furthermore, the future research directions of the preparatin were pointed out.