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目的分析影响中药注射剂安全性的因素,探讨防范其不良反应的对策。方法通过查阅近年来有关中药注射剂不良反应文献资料,总结归纳中药注射剂不良反应的发生原因,提出对策和建议。引起中药注射剂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、质量标准不完善、临床使用不恰当等多方面。结果与结论中药注射剂安全性应引起高度重视,加强中药注射剂安全性再评价工作。
Objective To analyze the factors affecting the safety of traditional Chinese medicine injections and to explore the countermeasures against its adverse reactions. Methods Through reviewing the literature on the adverse reactions of traditional Chinese medicine injections in recent years, the causes of the adverse reactions of traditional Chinese medicine injections were summarized and the countermeasures and suggestions were proposed. There are many reasons for the adverse reactions of TCM injections. The main manifestations are: unstable quality of APIs, imperfect quality standards, and inappropriate clinical use. Results and conclusions The safety of traditional Chinese medicine injections should be highly valued and the safety reevaluation of Chinese medicine injections should be strengthened.