中药注射剂是我国急诊常备中药制剂,临床疗效确切,但因成分复杂、生产条件要求苛刻、现行质量可控性差、临床使用不当等问题,不良反应时有发生,严重影响其应用与发展。在常规检查、多组分测定、化学指纹图谱的基础上,重点从生物活性检定的角度开展了中药注射剂不良反应与质量波动早期预警方法的研究,建立"基于常规检查-化学分析-生物评价序贯检测的质量控制方法与模式",以保证注射剂质量的稳定性与一致性,解决由药物质量因素引发的中药注射剂不良反应问题。

Chinese materia medica injection(CMMI) is a particular modern preparation for the first-aid of common in China,which has definite and quick effect.However,the application and development of CMMI are also embarrassed by adverse drug reaction(ADR),the complex components,strict production conditions,imperfect quality standard,lacking in ways and means of quality control,improper application in clinic,and so on.Supported by the national fund correlated,the investigation of the early prediction on quality fluctuation and ADR by controlling the stability and consistency of quality has been explored,and some innovative thought and method have been proposed,so as to establish the mode of quality control based on the 'routine examination,chemical analysis,and biological assessment'.Then the safety and efficacy in CMMI might be guaranteed,furthermore,the CMMI might be getting sustainable development

国家杰出青年科学基金项目(30625042);国家中医药管理局中医药科学技术研究专项(06-07ZP58);“十一五”国家科技支撑计划重点项目(2006038076126)