19份中药注射剂说明书规范性调查

Investigation of 19 Directions of Traditional Chinese Medicine Injections

目的对我院门诊19份中药注射剂说明书进行调查分析,了解中药注射剂说明书现状,为临床合理用药提供参考。方法依据国家食品药品监督管理局颁布的规范,收集我院门诊药房所使用的、具有国药准字批准文号的19份中药注射剂说明书进行综合分析。结果在19份中药注射剂说明书中规定的14个项目标注率达100%,但对用药安全有重要影响的项目,如儿童用药、老年用药、临床试验、药理毒理、药代动力学仅部分药品有标注,标注率相对较低。结论中药注射剂说明书项目标注不全,不能充分发挥指导临床合理用药的作用。需要完善相关标注,规范中药注射剂说明书,促进临床安全、有效、合理用药。

Objective To investigate and analyze 19 directions of traditional Chinese medicine injections in outpatient service,to understand current traditional Chinese medicine injection,in order to provide references for clinical rational drug use.Methods According to a specification issued by the State Food and Drug Administration,and collection of hospital outpatient pharmacy use with the country medicine accurate,19 directions of traditional Chinese medicine injections were analyzed.Results In 19 traditional Chinese medicine injections specification specified in the 14 items marked rate reached 100%,but the drug safety has important implications for the project Olny some of Children,older drugs,clinical trials,pharmacology and toxicology,pharmacokinetics drugs have mark,and mark rate is relatively low.Conclusion Drug instructions project tagging is not complete,so that it can not give full play to the role of guide clinical rational drug use.Relative marking should be perfected,drug instructions be standardized,clinical safety,effective and rational drug use be promoted.