对现行中成药说明书的调查和思考

目的:促进中成药说明书书写和印制规范化。方法:调查常用的5种剂型106份中成药说明书,按国家有关规定进行分析。结果:大部分中成药说明书均存在问题,如主要成分排序不正确,功能主治表述不规范,用法用量不详细,不良反应标注不客观,禁忌和注意事项混杂不清,药物相互作用、药理毒理、药动学缺乏研究资料。结论:中成药说明书书写和印制不规范应引起药品监督管理部门的重视,进一步加大监管力度。

Considerations on Package Inserts in Force of Chinese Traditional Patent Medicine

OBJECTIVE： To promote the standardization of the packing inserts of Chinese traditional patent medicine in the writing and printing. METHODS： A total of 106 package inserts of 5 common dosage forms of Chinese traditional patent medicine analyzed in accordance with the national standard. RESULTS： Problems were found in most of the package inserts of Chinese traditional patent medicine, which manifested as chaotic ranking of essential components, non- standard stating of actions and indications, unclear stating about dosage and administration, nonobjective in the labeling of adverse drug reactions, confusion between contraindication and precautions, lacking of research document on drug interactions, pharmacology ＆ toxicology and pharmacokinetics. CONCLUSION ： The drug surveilance agency should attach importance to and tighten control on the nonstandard writing and printing of packing inserts of Chinese traditional patent medicine .