摘要
目的:分析国家食品药品监督管理总局批准的药品补充检验方法所需对照品的可获得性,评估方法的可使用性,并思考改进对照品的保障供应思路。方法:收集并整理2003-2013年批准的药品补充检验方法,确定所需对照品的种类和数量,查阅国内法定药品标准物质供应机构的供应目录。结果:已批准的189个药品补充检验方法共需对照品167种。国内法定药品标准物质供应机构可供应157种,占94.0%;暂不能供应的是10种,都已经列入研制计划或正在研制中。结论:标准物质供应机构很好的满足了药品补充检验方法所需对照品的供应,确保了95.8%已批准方法的可使用性。针对暂不能提供对照品以及将来方法所需对照品供应的问题,一是需要供应机构考虑采用新技术及时研制;二是需要行政监管部门考虑扩大对照品的认可范围,借助其他标准物质供应平台,纳入溯源明确的对照试剂。
Objective： To investigate the feasibility of supplementary drug testing methods （STMs） ap- proved by S（C） FDA by reviewing the availability of corresponding reference substances. Methods： The investigation was conducted in a stepwise way as follows： collect and organize the STMs which had been approved by S（C） FDA between 2003 and 2013, identify the reference substances used for STM and then compare with catalog of ref- erences substances for drug testing by official provider in China. Results： In total, 189 STMs had been approved, and 167 kinds of reference substances were needed. Among them, 157 kinds could be provided by official domestic provider of reference substances, accounting for 94.0% ; eight STMs were impacted because of unavailability of ref- erence substances, which took up about 4.2% of the approved ones. Ten reference substances were unavailable. Conclusion ： The reference substances provided by domestic official provider to a large extent meet the needs of STMs. Regarding the provision of unavailable reference substances at present, the provider needs to speed up the preparation with new techniques; the administrative regulatory body should extend the scope of authorized reference substances with the help of other qualified providers.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2014年第16期1858-1860,共3页
Chinese Journal of New Drugs
基金
国家质量监督检验检疫总局<"双打"相关产品检验鉴定方法研究专项>基金(2012104008-1-08)
国家食品药品监督管理总局<食品药品应急检验中检验标准问题研究>基金(20131203)
关键词
掺杂掺假药品
补充检验方法
对照品
可获得性
标准物质供应机构
adulterated medicines
supplementary drug testing methods
reference substances
availability
provider of reference materials
