320份中药说明书标注不良反应、禁忌及注意事项分析

目的 对520份中药说明书中与安全用药关系最直接的不良反应、禁忌、注意事项3项内容进行调查,评价分析目前中药说明书规范、完善的情况.方法 依据<中华人民共和国药品管理法>对药品说明书的规定,收集了5家医院的中药说明书;520份,按剂型分类对调查的5项内容进行统计.结果 在520份中药说明书中,同时注明3项内容的有54份,占总数10.6%;分别注明不良反应的有62份,占总数19.83%;注明禁忌的有82份,占总数25.65%;注明注意事项的有257份,占总数74.06%.结论 药品说明书是指导临床正确使用药品的技术性资料和依据,制药企业应按<药品管理法>对中药说明书的规定,规范、完善说明书的内容,保证药品质量,保障用药安全.

Analysis of adverse reactions, contraindications and notices labeled in 320 traditional Chinese medicine Instructions

Objective To investigate three items, i.e. adverse reactions, contraindications and notices of 320 traditional Chinese medicine instructions, which are directly related to the safe administration of medicines, and to evaluate and analyze the standardization and perfection of traditional Chinese medicine instructions. Method 320 traditional Chinese patent medicine instructions have been collected from three hospitals (Hospital of Henan University, Level A and Level B Affiliated Hospitals) according to the "Drug Administration Law of P. R. China"and statistically analyzed the three items according to their dosages. Results Among the 320 instructions, 34 (10.6%) have all the three items, 62(19.83%) have ADR, 82 (25.63%) have contraindication, and 237 (74.06%) are attached with notices. Conclusion Medicine instructions are the technical documents and legal basis for patients to use medicine reasonably in clinic, so the pharmaceutical enterprises should standardize and perfect the items of instructions of traditinal Chinese medicine, guarantee the medicine quality and assure the safe usage of the individuals in accordance with the" Drug Administration Law of P. R. China".