Prediagnostic methods for the hemolysis of herbal medicine injection

Ethnopharmacological relevance: The Xue-Sai-Tong injection, a traditional Chinese medicine injection with total saponins extracted from Sanchi Ginseng, has been used for more than half a hundred years to treat coronary artery disease. The study is to establish a prediagnostic method for the hemolytic adverse effect of herbal medicine injection by taking Xue-Sai-Tong injection as an example. Materials and methods: A new method named "fuzzy dissemination" was established to identify the hemolytic ginsenosides in Xue-Sai-Tong injection on the basis of fuzzy changes of individual ginsenosides in the injections altered by re-adding the fractions prepared from the total saponins and statistic analysis between hemolytic degrees and individual ginsenosides. Related substances test, safety tests and fingerprints of the injections in different batches were tested. Results: HD50, P-50 and interactions on hemolysis of individual ginsenosides were examined. Experiment indicated that the content of Rg(1), Rg(2), M-51 (an unknown ingredient with retention time at 51 min in HPLC) and M-70 in Xue-Sai-Tong injection showed a significant positive correlation with hemolytic degree, and the content of R-1, Re, Rb-1 and Rd showed a significant negative correlation with hemolytic activity. Furthermore HD50 of injection exhibits superiority to other tests for the hemolysis of injections. Abnormal hemolysis in some batches of injections was observed, but there were no significant differences among injections of different batches in related substances test, safety test and fingerprints. Conclusions: This is an original method to analyze active ingredients of a complicated integrity instead of studying on individual ingredients, it showed that the interactions of some individual ginsenosides and some unknown micro-ingredients in Xue-Sai-Tong injection were the major factors causing hemolysis, and this method could also be utilized in research of corresponding aspects. HD50 of injection can reflect the changes of hemolytic property of injections caused by not only the change of active constituents of injection, but also the auxiliary materials. Thus it was recommended as an index for the hemolytic prediagnosis of the injections in practice. (C) 2011 Elsevier Ireland Ltd. All rights reserved.