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·药事管理·

全国医疗机构制剂现状调研及问题分析 Δ

蔡明远 1，2＊ ，张翠莲 ，周 亮 ，颜 青 ，左 玮 （1.中国医学科学院北京协和医学院药剂科/疑难重症及罕见病
3
3
1
1 #
国家重点实验室，北京 100730；2.天津中医药大学中药学院，天津 301617；3.国家卫生健康委医院管理研究
所药事管理研究部，北京 100044）

中图分类号 R952 文献标志码 A 文章编号 1001-0408（2022）05-0513-06
DOI 10.6039/j.issn.1001-0408.2022.05.01

摘 要 目的 了解我国医疗机构制剂的发展现况，促进医疗机构制剂持续健康发展。方法 在国家药事管理专业质控中心的组织
下，采用网络调查的形式，对各省（区、市）和新疆生产建设兵团的二级及以上综合医院填报的2019年全国医疗机构制剂相关指标
数据进行统计分析。结果 在全国4 639家医院中，具有制剂批准文号的医院占9.36％，设立制剂室的医院占8.15％。医疗机构制
剂生产/获批比（常规生产制剂品种数与具有制剂批准文号制剂品种数的比值）的平均值为0.72，有41.52％的医院该比值集中于
1～0.9。医疗机构制剂的主要生产方式为医院自产，且医院级别越高，其自产与委托加工相结合的生产方式占比越高，委托加工
的占比越低。在有制剂批准文号的医院中，拥有中药制剂的占比最高（73.66％），其次为普通化学制剂（69.93％）。从医疗机构制
剂年产值看，三级医院高于二级医院，民营医院高于公立医院，且其与医疗机构制剂生产方式、生产品种以及医院是否设立制剂室
有关。医疗机构制剂在区域发展上呈现出华中、华北、华南地区高于东北、西北、西南地区的趋势。结论 目前我国医疗机构制剂
以医院自产为主，制剂类型较单一，且存在各级别各地区医疗机构制剂发展不平衡、制剂规模缩小的问题。建议医院重视医疗机
构制剂创新，尤其是疗效确切的特色制剂的发展，充分发挥其“拾遗补缺”的作用；同时，要加强对制剂调拨的政策支持、重视区域
制剂中心的建立。
关键词 医疗机构制剂；制剂批文；公立医院；民营医院；制剂室；发展现状

Nationwide investigation and problems analysis of pharmaceutical preparations in medical institutions
CAI Mingyuan ，ZHANG Cuilian ，ZHOU Liang ，YAN Qing ，ZUO Wei（1. Dept. of Pharmacy/State Key
3
3
1
1
1，2
Laboratory of Complex Severe and Rare Diseases，Peking Union Medical College Hospital，Chinese Academy
of Medical Sciences，Beijing 100730，China；2. College of Traditional Chinese Medicine，Tianjin University of
Traditional Chinese Medicine，Tianjin 301617，China；3. Dept. of Pharmaceutical Administration Research，
National Institute of Hospital Administration，National Health Commission，Beijing 100044，China）
ABSTRACT OBJECTIVE To investigate the situation of pharmaceutical preparations in medical institutions（hereinafter refer to
hospital preparations），and to promote the sustained and healthy development of hospital preparations. METHODS Under the
organization of National Pharmacy Administration & Quality Control Center，internet survey was adopted to statistically analyze the
data of hospital preparations in 2019 that was completed and reported by the secondary general hospitals and above in provinces
（cities，districts） and Xinjiang Production and Construction Corps. RESULTS Among the 4 639 hospitals，9.36％ had drug
approval numbers and 8.15％ had preparation laboratories. The average ratio of the number of hospital preparations in production to
the number of preparations approved was 0.72，and that of 41.52％ hospital was concentrated in 1-0.9. Self-produced by hospital
was the main production mode of hospital preparations；the higher hospital level was，the higher the proportion of self-production
combined with commissioned processing，while the lower the proportion of commissioned processing only. In hospitals with
preparation approval numbers，the proportion of owning TCM preparations was the highest （73.66％），followed by common
chemical preparations（69.93％）. From perspective of annual output value of hospital preparations，tertiary hospitals were higher
than secondary hospitals，and private hospitals were higher than public hospitals；it was related to the production mode，varieties
of hospital preparations and the establishment of the preparation laboratories. There was a trend that the development of hospital
preparations in Central China，North China and South China
Δ 基金项目：国家自然科学基金面上项目（No.81974183）；吴阶平
was better than that in the Northeast China，Northwest China
医学基金会临床科研专项资助基金项目（No.320.6750.2020-04-06）；中
and Southwest China. CONCLUSIONS At present，hospital
央级公益性科研院所基本科研项目（No.2020-RW310-003）
preparations in China are mainly made in medical institutions，
＊本科生。研究方向：临床药学。E-mail：cmy18366784819@163.
com and the types are relatively limited. The regional development
# 通信作者：副主任药师，博士。研究方向：临床药学。E-mail： is unbalanced and the scale of hospital preparations is reduced.
eileenzuo@163.com It is suggested that medical institutions should pay attention to

中国药房 2022年第33卷第5期 China Pharmacy 2022 Vol. 33 No. 5 ·513 ·