随着《中医药法》的出台，经典名方制剂的应用引起各家企业的重视。目前经典名方制剂相关研究主要集中于产业、专利、质量、临床等方面，缺乏对于普及应用方面的整体研究，其中制剂说明书方面的研究作为应用研究的一个环节也越来越受到关注。分析我国现有的关于中成药说明书研究的文献，多数研究以定性分析为主，缺乏具体样本的统计分析以及数据对比和具体建议。研究了128品目的日本汉方制剂说明书及相关用药指导，具体分析了日本汉方制剂和我国中成药在中药经典名方的选择、说明书内容以及目录索引和指导手册方面的差异，并进行了初步的分析探讨，提出了在经典名方目录的确立、用药说明书内容以及索引方式的改善、整体指导手册及应用数据库的确立3个方面的具体建议，以对我国中药经典名方的应用和发展提供参考依据。

With the promulgation of the "Chinese Medicine Act", the application of classic prescriptions has attracted the attention of various companies. At present, related researches mainly focus on industry, patents, quality, clinic and other aspects, lacking overall research on popularization and application, and the research on pharmaceutical instructions has received increasing attention as a link in applied research. Reviewing the existing literature on Chinese patent medicine specification research in China, we found that most studies are qualitative analysis, lack of targets, data comparison, and specific recommendations, so the specific improvement of the Chinese patent medicine specification is limited. In this paper, the 128-item Japanese Kampo preparation instructions and related medication instructions were studied. The specific differences between the Japanese Kampo preparations and Chinese patent medicines in the selection of traditional Chinese medicines, the contents of the specific manuals, and the contents of the index and guidance manual were analyzed. Preliminary analysis and suggestions were made on the establishment of the classic prescription name list, the contents of the drug instruction manual, the improvement of the indexing method, and the establishment of overall instruction manual and the application database, in order to provide references for the application and development of traditional Chinese medicine.

国家重点研发计划（2017YFC1704000）；国家自然科学基金资助项目（30800125）；中国科协委托课题；民族医药教育部重点实验室自主课题资助（KLEM-ZZ201805）