盐酸丁卡因注射液的贮存期探讨

Study on the Stability of Tetracaine Hydrochloride Injection

目的研究盐酸丁卡因的稳定性和贮存期。方法用HPLC测定盐酸丁卡因及分解产物对丁氨基基苯甲酸的含量,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%。经典恒温法测定得25℃的储存期为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贮存期可暂定1年。

OBJECTIVE To study the stability and expiration of tetracaine hydrochloride injection. METHODS THE contents of tetracaine, hydrochloride and its degradation product were determined by mears of HPLC. The samples were tested by accelerating experiment, classical constant-temperature experment and room temperature storage,respectively. RESULTS The content of tetracaine dydrochloride was slowly reduced while temperatuae 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 nd month respectively at 40℃ and the humidity 75% with accelerating experi ment. The expiration was found to be 15 months at 25℃ with classical constant-temper ature experiment. Its content was 96.67% for 1 year and 89. 34% for 2 year under room temperature storage. CONCLUSION The date obtained from the three experiments were similar, so that this injection may be stored for 1 year at room temperature.