药检机构留样库贮藏温度合理设置浅析  

Analysis on Reasonable Setting of Storage Temperature in Sample Retention Facility of Drug Testing Institutes

作　　者：董红环 杨玥莹 黄宝斌 梁静 高芳[1] 黄清泉[1] Dong Honghuan;Yang Yueying;Huang Baobin;Liang Jing;Gao Fang;Huang Qingquan(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药师》2020年第2期388-390,共3页China Pharmacist

摘　　要：目的:探讨药检机构留样库的合理贮藏温度,建立与国际接轨的留样库贮藏温度体系,以满足受理药品的贮藏要求,保证检验结果准确可靠,推动药检机构国际化发展。方法:对比国内外现行药典以及药品注册标准,探析国内药检机构留样库贮藏温度设置中可能存在的一些不合理之处,并提出建议。结果与结论:国内药检机构应参考受理样品的生产国药典和药品注册标准针对性、合理性设置留样库贮藏温度。同时,相关单位和机构也应进一步规范国内药品标准体系对贮藏温度表述,推进不同国家药品标准体系贮藏条件的"标准化",以此确保药检机构更加合理设置留样库贮藏温度。Objective:To explore the reasonable storage temperature in sample retention facility of drug testing institutes,establish a storage temperature system of the sample retention facility in line with international standards to meet the storage requirements of accepted drugs,ensure the accuracy and reliability of the test results,and promote the international development of the drug testing institutes.Methods:By comparing the current pharmacopoeias at home and abroad and drug registration standards,the author discussed the possible irrationality of storage temperature for sample retention facility and put forward some suggestions.Results and Conclusion:The drug testing institutes should refer to the domestic pharmacopoeia and drug registration standard to set storage temperature for sample retention facility.Meanwhile,in order to make storage temperature of sample retention facility in drug testing institutes more reasonable,the relevant departments should further standardize the expression of storage temperature and promote the"standardization"of storage conditions among different drug standard systems.

关 键 词：贮藏温度 留样库 药典 注册标准 药检机构 国际化 

分 类 号：R95[医药卫生—药学]