盐酸丁卡因注射液的稳定性研究

 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声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98.68%，2个月为96.33%，3个月为94.37%。经典恒温法测得25℃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96.67%，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。

Study on the stability of tetracaine hydrochloride injection

OBJECTIVE To study the stability and expiration of tetracaine hydrochloride injection. METHODSThe 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 l st,2nd and 3rd month respectively at 40C 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 the year and 89.34% for 2 years under room temperature storage.