摘要
目的:比较各省中药配方颗粒管理细则中医疗机构相关要求的异同,总结可借鉴经验。方法:收集各省细则对医疗机构的人员、采购、验收、保管、调剂、临床使用等方面的要求,横向比较差异,纵向对比国家政策文件。结果:北京的人员要求融合了《医院中药饮片管理规范》《药品经营质量管理规范》;浙江等明确了质量保证协议内容,天津等明确了对生产企业资质和药品质量的审核内容;浙江等鼓励包装标签标注辅料,山西等提出采用二维码标注;北京、浙江等围绕调剂设备及其计量校验、使用维护和清洁制度、调配专用包装、过程追溯等方面提出具体要求。结论:建议优化人员要求,推广信息化标签标注,加强调剂设备管理,并依托区域协同机制,提升医疗机构中药配方颗粒质量管理水平。
Objective:To compare the similarities and differences in requirements on medical institutions across provincial management rules for traditional Chinese medicine(TCM)formula granules and to analyze the aspects worth referencing.Methods:Provincial management rules regarding personnel,procurement,acceptance,storage,dispensing,and clinical use in medical institutions were collected to conduct horizontal comparisons of differences and vertical comparisons with national policy documents.Results:Beijing’s personnel requirements integrated the Standard for Management of Chinese Herbal Medicine in Hospitals with the Good Supply Practice for Pharmaceutical Products.Provinces like Zhejiang specified the content of quality assurance agreements,while Tianjin and others clarified the review criteria for manufacturer qualifications and drug quality.Zhejiang and other provinces encouraged labeling excipients on the package,while Shanxi and others proposed the use of QR codes for labeling.Beijing,Zhejiang,and other provinces put forward specific requirements regarding dispensing equipment,its calibration,usage,maintenance and cleaning protocols,dispensing-dedicated package,and process traceability.Conclusion:It is recommended to optimize personnel requirements,promote the use of informational labeling,strengthen dispensing equipment management,and leverage regional collaborative mechanisms for TCM formula granules quality management improvement in medical institutions.
作者
孔维崧
曹登焰
史雪敏
薛亚
贾婷婷
钱凤丹
徐燕丰
张立超
KONG Weisong;CAO Dengyan;SHI Xuemin;XUE Ya;JIA Tingting;QIAN Fengdan;XU Yanfeng;ZHANG Lichao(Department of Pharmacy,Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200071,China;Department of Pharmacy,Xishui Hospital of Traditional Chinese Medicine,Guizhou Zunyi 564600,China)
出处
《中国医药导刊》
2025年第9期960-966,共7页
Chinese Journal of Medicinal Guide
基金
上海中医药大学科技发展项目(24KFW13)。
关键词
中药配方颗粒
管理细则
医疗机构
药事管理
Traditional Chinese medicine formula granules
Management rules
Medical institutions
Pharmaceutical administration
