【摘要】 目的　研究盐酸丁卡因注射液的稳定性及贮存期。方法　用HPLC测定盐酸丁卡因及分解产物对丁氨基苯甲酸的含量 ,将产品用加速实验法 ,经典恒温法和室温留样观察法进行实验。结果　盐酸丁卡因的含量随温度升高和时间延长逐渐下降 ,产品加速实验得出 :温度 40℃ ,湿度 75 %条件下 ,盐酸丁卡因放置 1个月含量为 98.6 8% ,2个月为 96 .33% ,3个月为94.37%。经典恒温法测得 2 5℃的贮存期为 15个月。室温留样观察实验证实 :盐酸丁卡因注射液放置 1年含量为 96 .6 7% ,放置 2年为 89.34%。结论　 3种实验方法测得的数据基本一致。盐酸丁卡因注射液的有效期可暂定为 1年更多还原

【Abstract】 OBJECTIVE To study the stability and expiration of tetracaine hydrochloride injection.METHODS The contents of tetracaine hydrochloride and its degradation product were determined by means of HPLC.The samples were tested by accelerating experiment,classical constant temperature experiment and room temperature storage,respectively.RESULTS The content of tetracaine hydrochloride was slowly reduced while temperature rising and time prolonging.Its content was 98.68%,96.33% and 94.37% at the end of the 1 st,2 nd and 3 rd month respectively at 40℃ and the humidity 75% with accelerating experiment.The expiration was found to be 15 months at 25℃ with classical constant temperature experiment.Its content was 96.67% for 1 year and 89.34% for 2 years under room temperature storage.CONCLUSION The data obtained from the three experiments were similar,so that this injection may be stored for 1 year at room temperature.更多还原