摘要
目的:探讨药品贮存条件规定中存在的问题,为完善药品贮藏条件规定提供参考。方法:研究药品标准,规范对药品贮存条件的相关规定,分析贮存条件术语、稳定性试验条件与贮藏条件规定的衔接等问题,提出相应的建议。结果与结论:现行标准或规范对药品贮藏条件的相关规定,在温度、湿度范围规定以及贮存条件与稳定性试验衔接关系等方面尚存在不足之处。建议完善药典贮藏条件术语的规定,完善稳定性试验条件与贮藏条件的衔接关系,完善稳定性试验设计方案。
Objective： To discuss the existing problems of drug storage conditions so as to provide some references for the improvement of storage conditions. Methods： Drug specifications and regulations for drug storage conditions were studied, the problems in cohesion of storage condition terminology, stability tests and requirements for storage condition were analyzed, and the corresponding advice was offered. Results and Conclusion： In the current specifications and guidelines for drug storage conditions, there are some deficiencies in the requirements of temperature and humidity and in the coherence of storage conditions and stability tests. It is necessary to improve the definitions of storage condition terms, the coherence of stability tests and storage conditions, and the protocols of stability test.
出处
《中国药事》
CAS
2015年第5期482-484,共3页
Chinese Pharmaceutical Affairs
关键词
药品贮藏
条件术语
标准规定
稳定性试验
标准讨论
drug storage
condition terminology
standards and regulations
stability test
standard discussion
