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中日两国医疗机构配制制剂对比研究
引用本文:李莹,李文君,卢梦情,席晓宇.中日两国医疗机构配制制剂对比研究[J].中国医院药学杂志,2020,40(7):831-834,822.
作者姓名:李莹  李文君  卢梦情  席晓宇
作者单位:中国药科大学国家药物政策与医药产业经济研究中心, 江苏 南京 211198
基金项目:中国药科大学"双一流"学科创新团队建设项目(CPU2018GY39);国家科技重大专项重大新药创制专项(2018ZX09721003)
摘    要:目的:对比中日医疗机构制剂的差异,总结日本实践探索的可借鉴经验,以改善医疗机构制剂的供应、安全性和有效性。方法:对比分析中日两国医疗机构制剂在相关概念、监管、配制和使用等方面的差异。结果:日本对院内制剂的监管、配制和使用具有非常丰富的实践探索,其实践经验对我国具有较高的借鉴价值。结论:我国应灵活调配适用于特殊人群的制剂,对不同的医疗机构制剂进行分类管理,建立统一的质量标准,注重医疗机构制剂使用环节,以改善医疗机构制剂的供应、安全性和有效性。

关 键 词:医疗机构制剂  中日  分类  监管  配制  使用
收稿时间:2019-11-20

Comparative Study onhospital preparations in China and Japan
LI Ying,LI Wen-jun,LU Meng-qing,XI Xiao-yu.Comparative Study onhospital preparations in China and Japan[J].Chinese Journal of Hospital Pharmacy,2020,40(7):831-834,822.
Authors:LI Ying  LI Wen-jun  LU Meng-qing  XI Xiao-yu
Affiliation:The Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University, Jiangsu Nanjing 211198, China
Abstract:OBJECTIVE To compare the differences of preparations between Chinese and Japanese medical institutions and summarize the reference experience of practical exploration in Japan in order to improve the supply, safety and efficacy of preparations in medical institutions.METHODS The differences in concept, supervision, preparation and use of preparations from medical institutions between China and Japan were compared and analyzed.RESULTS Japan has rich experience in supervision, preparation and use of hospital preparations, which has a high reference value for China.CONCLUSION In order to improve the supply, safety and effectiveness of hospital preparations, China should flexibly prepare hospital preparations suitable for special populations, classify and manage different kinds of hospital preparations, establish a unified quality standard and pay attention to the use of hospital preparations.
Keywords:hospital preparations  China and Japan  classification  supervision  preparation  usage  
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