Predicting expiration date of torasemide injection by classical constant-temperature experiment
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摘要: 目的 预测托拉塞米在室温下的有效期。 方法 采用HPLC法测定主药含量，用经典恒温法预测其有效期。 结果 托拉塞米的降解反应属一级反应，在室温（25℃）条件下的分解速度常数K25℃=5.1869×10-6，该注射液在25℃时的有效期t0.9=2.32年。 结论 自制的托拉塞米注射液的有效期暂定为2年。Abstract: Objective To investigate the stability of torasemide injection and predict its expiration date in room temperatue. Methods The contents of torasemide were determined by HPLC. The expiration date was predicted by classical constant-temperature experiment. Results The contents of torasemide degradation with time according to a first order reaction at room temperature (25℃). The disintegration rate constant K was K25℃=5.1869×10-6 h-1 and the expiration date of torasemide injection was t0.9=2.32 years. Conclusion The torasemide injection expiration date was tentatively scheduled for two years.
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Key words:
- torasemide /
- classical constant-temperature experiment /
- stability /
- expiration date
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[1] 胡瑞钺,田波,喻建勇.托拉塞米的临床应用与比较探讨[J].中国医药导报,2010,7(2):189-190. [2] 国家食品与药品监督管理局.托拉塞米质量标准(试行)YBH05982005[S]. 2005:1. [3] 美国药典委员会. 美国药典(第34修订版)[S]. 北京:化学工业出版社,2011:4474. -
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