Investigation And Study On Adverse Drug Reaction Of Shuanghuanglian Injection

Traditional Chinese medicine injection (TCMI) is widely used in the treatment of acute and severe diseases, such as infection, cardiovascular disorder and cancer for the high bioavailability and rapid unset. At present, about 100 kinds of TCMI have been approved for manufacture. With the expansive use of TCMI in clinic, adverse drug reactions (ADRs), hypersensitive reactions especially, are reported more frequently. TCMI owns a wide range of indication, and many TCMIs are composed by multiple herbs. Each herb contains numbers of monomer ingredients, and each ingredient differs in activity. ADRs induced by TCMI could involve multiple organs, tissues and systems. Because of the ADRs, new drug development and application of TCMI in clinic are restricted. It is even possible that the TCMI be kicked out of the market at last.Shuang Huang Lian Injection (SHLI), one type of TCMI, has caused severe ADRs, even led to death due to anaphylactic shock. We searched the data base CNKI and obtained ADRs reports of SHLI from 1989 to 2008. Through analysis of these reports we concluded the status and challenges of SHLI and proposed several measurements. We also compared the quality of SHLI products of different lots from different companies, and investigated the quality control methods and standards in order to stabilize the quality and enhance the controllability. The results demonstrated that SHLI from different companies differed in components, while the deviation among different lots from the same company was smaller. We propose several measurements for quality development according to the results.The ADRs induced by SHLI are possibly attributed to complex components and various mechanisms of activity. On the condition of maintaining the activity, removing the unknown components could be an effective way to reduce the ADRs. In our study, various parts of SHLI were produced by developing the extracting methods, and screened to identify each one's activity in vitro, which could provide the basis for a second development of SHLI if more efficient parts are found. All parts of SHLI were observed to be effective in the screening tests for antivirus and antibacterial activity, among which part J1 from Flos lonicera, part L3 and L2 from Fructus forsythia, and part H1 from Scutellaria radix demonstrated good activity in vitro.