我国兽用化学药品标准物质与国内外药品标准物质管理模式和研制技术的比较研究

Comparative Study of Management Mode and Development Technology on Chinese Veterinary Chemical Reference Standards and Domestic or Foreign Drug Reference Standards

关键词:  药品标准物质 兽用化学药品 管理模式 研制技术 比较

Key words:  drug reference standards  veterinary chemical drugs  management mode  development technology  comparison

摘要:

为进一步提高我国兽用化学药品标准物质管理水平和研制技术，对中国、美国、欧盟、国际药典药品标准物质和我国兽用化学药品标准物质的管理模式进行了比较归纳，对各国标准物质研制中涉及的原料筛选、结构确证、均匀性评估、定值、稳定性监测等研制技术进行了总结梳理，以期为我国兽用化学药品标准物质的管理与研制提供借鉴和参考。

Abstract:

In order to further improve the management level and development technology of Chinese veterinary chemical reference standards, the management mode of drug reference standards in China, the United States, the European Union, the international pharmacopoeia and our country"s veterinary chemical reference standards are compared and summarized. Raw material screening, structure confirmation, uniformity evaluation, determination, stability monitoring, etc. involved in the development technologies of reference standards are induced in order to provide reference for the management and development of our country"s veterinary chemical reference standards.