中药注射剂的安全性评价进展

分析中药注射剂不良反应特点和发生原因,探讨其对策。通过查阅近年来有关中药注射剂不良反应文献资料,结合临床工作实践,总结归纳中药注射剂不良反应的特点、发生原因,提出对策和建议。中药注射剂的不良反应广泛复杂;引起不良反应的原因是多方面的,主要表现为:原料药质量不稳定、制剂工艺及质量控制不完善、临床使用不恰当等多方面。中药注射剂不良反应危害大,应引起高度重视,加强中药注射剂安全性再评价工作。

Revaluation the safety of Traditional Chinese Medicine injections

To analyse the adverse drug reactions's characteristic and cause of Traditional Chinese Medicine (TCM) injections and discuss countermeasure.To refer to recent years literature of TCM injec- tions about ADRs and combine with clinic practice,summarize the characteristic and cause of TCM injec- tions,put forward countermeasure and advice.The ADRs of TCM injections are widely and complex,the reasons include that drug substance material quality is instability,preparation techniques and quality con- trol are incomplete,the use is out of the way and so on.The ADRs of TCM injections have great harm on patients,the people should pay attention to the safety of TCM injections and strengthen revaluation works.