半数溶血浓度测定在监测中药注射剂不良反应中的意义

ims] To study the significance of half hemolytic dosage in precontrolling adverse drug reaction of Chinese meteria medica injections. [Methods] Take Xuesaitong injections for example and determine half hemolytic dosage. Relavent substances test, in vivo hemolytic reaction, safety test as well as fingerprint chromotograms of TCM injections were examined for the injections with abnormal hemolytic phenomena. [Results] The results indicated that partial injections showed abnormal hemolytic phenomena in in-vitro test and hemolytic tendency in in-vivo hemolytic test with some individual showing stronger hemolysis. In the light of standard proposed by China's pharmacopeia, the relvent substance met the standard of China's pharmacopoeia. But pathology sections showed slight muscular irritant reaction and most rats only showed trend of slight hemolysis, few exhibited hemolysis. The result of safety test met the criterion in present China's pharmacopoeia. Moreover, the fingerprint chromotograms showed good similiarity between injections with normal and abnoraml hemolytic phenomena. [Conclusion] Half hemolytic dosage of TCM injections can be an index for the precontrolling their ADR not only in the hemolysis of TCM injections, but also for a reference to other ADR of TCM injection. It is better than the present methods used in China's Pharmacopoeia for the hemolytic evaluation test.