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从中药注射剂的不良反应浅析中药注射剂研发中的若干问题
引用本文:黄芳华.从中药注射剂的不良反应浅析中药注射剂研发中的若干问题[J].世界科学技术,2004,6(3):9-13.
作者姓名:黄芳华
作者单位:国家食品药品监督管理局药品审评中心 北京100038
摘    要: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。

关 键 词:中药注射剂  不良反应  安全性评价  临床使用  质量控制

Briefly Analyzing Some Problems in Research and Development of TCM Injections from The Untoward Effects of Them
Huang Fanghua.Briefly Analyzing Some Problems in Research and Development of TCM Injections from The Untoward Effects of Them[J].World Science and Technology(Modernization of Traditional Chinese Medicine),2004,6(3):9-13.
Authors:Huang Fanghua
Abstract: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.
Keywords:TCM injection  untoword effect  assessment of safety
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