中药注射剂的临床使用日趋广泛,在疾病的治疗中发挥了较好的作用,同时由其引起的不良反应也渐渐引起人们的注意。本文从中药注射剂的不良反应出发,评述了中药注射剂研发中值得注意的若干问题,主要从开发的立题依据、加强质量控制、注重非临床安全性评价和临床安全性评价等方面进行了讨论。

In recent years TCM injections have been widely used in clinical treatment day by day and played a considerable role in the treatment of diseases. Nevertheless people's attention is gradually aroused as to their untoward effects. Starting from the untoward effects of TCM injections this article comments on some problems which are worth attention in the research and development of such injections, for iusfance, the great attention paid to the basis of selecting development projects, the strengthening of quality control and the emphasis laid on the assessment of non-clinical and clinical safety.