Progress of non-clinic safety re-evaluation for traditional Chinese medicine injection
As an innovative dosage of traditional Chinese medicine(TCM),traditional Chinese medicine injection(TCMI)has been widely used in clinical practice since it has the advantage of fast absorption and high bioavailability.However,it also aroused a series of adverse reactions in clinical practice,which could be life-threatening.Consequently,it is crucial to establish a standardised and comprehensive non-clinical safety re-evaluation system for TCMI to guarantee the safety of its clinical medication and advance its progress.Herein,the research outlined the clinical adverse reaction/event(ADR/ADE)situation,manifestations and potential causes of TCMI,summarized the current research methods and progress of non-clinical safety re-evaluation in terms of general toxicity study,allergic reaction study,irritation and hemolytic test study,and safety pharmacology study.And the recommendations of non-clinical safety re-evaluation of TCMI for the continuation of future research were put forward,which will provide a reference for the continuation of relevant studies in the future.
traditional Chinese medicine injectionsafety re-evaluationadverse drug reactionallergic responsenon-clinical safety re-evaluation
NETL
NSTL
万方数据
