摘要
目的研究肝得宁水蜜丸在加速试验和长期试验条件下的稳定性并测算其有效期。方法根据《新药临床前研究指导原则汇编》,在模拟市售包装条件下,通过加速试验和室温贮存24个月,对其性状、含量测定等项指标进行考察。结果在考察期内,各项指标均符合规定。结论本品常温放置24个月,其质量稳定,故有效期定为24个月。
Objective To determine the expiry date of Gandening pills based on accelerating and long-term stability experiments. Methods According to the collection of preclinical guidelines for new drugs and under market packing conditions, quality indexes, such as content determination, shape and properties, were regularly determined in accelerating tests and after 24 months of storage. Results All the detectable results conformed to quali.ty standards. Conclusion The shelf life of these pills is defined as 24 months. The quality is stable after they are kept for 24 months in room temperature.
出处
《解放军药学学报》
CAS
2012年第5期426-427,450,共3页
Pharmaceutical Journal of Chinese People's Liberation Army
基金
解放军302医院自制制剂研发基金
No.434510Z0F1
关键词
肝得宁水蜜丸
稳定性
有效期
Gandening pills
stability test
expiry date
