摘要
Abstract
Objective The accelerated test and long-term test,properties of Entecavir Dispersible Tablets changes over time in the ef ect of dif erent environmental conditions under the law,for the production of drugs,packaging,storage, transport conditions and provide a scientific basis for the ef ective period to ensure the safety of clinical use.Methods Modeled on the Entecavir Dispersible Tablets listed packaging conditions,the accelerated test and long-term test according to the Pharmacopoeia appendix,"China"on their character,identification,dispersible uniformity,solubility,related substances,microbial limit examination and determination of content were investigated.Results In the study period,the indicators are in line with the provisions.Conclusion This product at a temperature of 40 ? C,relative humidity 75% placed under the conditions of 6 months or room temperature,relative humidity 60% placed under the conditions of 18 months,stable pharmaceutical formulations,which is valid for 18 months.关键词
恩替卡韦/抗病毒药/稳定性/有效期Key words
Entecavir dispersible tablets/Antiviral agents/Stability trial/Expiry date
