军队医疗机构应用传统工艺配制中药制剂备案管理的思考与建议  

File-making for Traditional Chinese Medicine Preparations Produced with Conventional Technologies in Military Healthcare Institutions

作　　者：龚伟玲 王伯阳 丁浩 管思梦 储藏 周苏萍 GONG Wei-ling;WANG Bo-yang;DING Hao;GUAN Si-meng;CHU Cang;ZHOU Su-ping(Administration for Drug and Instrument Supervision and Inspection of PLAJLSF,Beijing 100166,China)

机构地区：[1]联勤保障部队药品仪器监督检验总站,北京100166

出　　处：《解放军药学学报》2024年第3期247-250,共4页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的探讨在军队医疗机构实施传统工艺配制的中药制剂进行备案管理的可行性。方法通过对原国家食品药品监督管理总局发布的《关于对医疗机构应用传统工艺配制中药制剂实施备案管理的公告》(2018年第19号)和北京、天津、山东等省市出台的《传统工艺中药制剂备案细则》进行研究和梳理,分析总结在军队医疗机构实施传统工艺配制的中药制剂进行备案管理的优势。结果针对军队医疗机构制剂发展现状,提出推行应用传统工艺配制中药制剂备案管理的建议:明确备案品种剂型要求;严格执行制剂制备工艺要求;落实备案材料审查;加强备案品种监管。结论建议尽快出台军队医疗机构应用传统工艺配制中药制剂备案管理实施细则,促进军队医疗机构制剂创新发展。Objective To explore the feasibility of file-making for traditional Chinese medicine(TCM)preparations produced using traditional technologies in military medical institutions.Methods By consulting the Announcement on File-making for TCM Preparations Produced with Conventional Technologies in Medical Institutions issued by the State Food and Drug Administration and Specifications on File-making for TCM Preparations Produced with Conventional Technologies issued in Beijing,Tianjin and Shandong,the advantages enjoyed by military medical institutions in file-making for TCM preparations produced using traditional technologies were analyzed.Results In view of the current development of preparations in military medical institutions,this paper offered some recommendations.Conclusion The details of implementation of file-making for TCM preparations produced using traditional technologies in military medical institutions should be released as soon as possible to facilitate innovations of preparations in military medical institutions.

关 键 词：军队医疗机构 传统工艺 中药制剂 备案管理 

分 类 号：R95[医药卫生—药学]