摘要
目的:分析美国临方配制制剂对我国的借鉴意义,以弥补我国现有制剂的不足。方法:通过文献等分析美国临方配制制剂的基本情况、分类、调配过程、监管等现状。结果:美国关于临方配制制剂的法律体系建设较为完善,在调配和管理临方配制制剂方面积累了丰富的经验。结论:我国可借鉴美国关于临方配制制剂的经验,确定临方配制制剂的法律地位,建立相关的监管法规以及提供指导药剂师调配的指导和资源。
OBJECTIVE To analyze the reference significance of compounded drugs of America for China,in order to make up for the shortcomings of existing preparations in China.METHODS The basic conditions,classification,formulation process and supervision of compounded drugs in America were analyzed by literature.RESULTS The legal system for compounded drugs in the America is relatively complete,and America has accumulated rich experience in compounding and managing compounde ddrugs.CONCLUSION China should learn from the experience of compounded drugs in the United States to determine the legal status of compounded drugs,establish relevant regulatory regulations,and provide guidance as well as resources to guide pharmacist development.
作者
李莹
李文君
卢梦情
席晓宇
LI Ying;LI Wen-jun;LU Meng-qing;XI Xiao-yu(The Research Center of National Drug Policy&Ecosystem,China Pharmaceutical University,Jiangsu Nanjing 211198,China)
出处
《中国医院药学杂志》
CAS
北大核心
2020年第16期1776-1780,共5页
Chinese Journal of Hospital Pharmacy
基金
中国药科大学"双一流"学科创新团队建设项目(编号:CPU2018GY39)
国家科技重大专项重大新药创制专项(编号:2018ZX09721003)。
关键词
临方配制制剂
美国
分类
调配
监管
compounded drugs
US
classification
compounding
supervision
