中药注射剂，是现代药物制剂技术与传统中医药相结合的产物。[1]截止2009年，中药注射剂的市场规模已经达到200亿元以上。[1]但是，中药注射剂的不良反应事件极多，引发舆论关注。[2]2009年，国家食品药品监督管理局要求对中药注射剂安全性进行再评价。[1]
中药注射剂目前在中国大陆有多种定义，但内容大致相同：
中药注射剂始于1941年初太行山区八路军一二九师卫生部制成柴胡注射剂，这是中药第一次被制成注射剂并被用于临床。[2]
1954年武汉制药厂生产的柴胡注射剂上市，是中药注射剂的第一次工业化生产。[2]1980年代，注射剂作为中药新剂型相继研制的品种一度多达1400余种。历经淘汰，仍有近140种具备正式批准文号的注册上市品种。截止2009年，中药注射剂的市场规模已经达到200亿元以上。[1]
截至到2010年，中国大陆批准使用的中药注射液有120多种，占整个中药份额的3%，但药物不良反应的事件占整个中药不良反应的70%。[5]
國藥監2017年報告，中藥導致嚴重不良反應事件中，注射液佔了高達八成半。[6]
据国家药品不良反应监测中心统计，截止到2009年，中药注射剂的不良反应/事件病例报告占了整体中药病例报告的72.64%，其中严重不良反应/事件报告占了中药严重病例报告的76.57%。[1]
原国家中医药管理局副局长任德权认为，相比西药注射剂，中药注射剂内含物质多种，作用机制多样，研究难度高，同时其现代基础研究、生产技术与管理参差不齐。[2]
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