北京大学学报（医学版）2001，Vol.33Issue(3)：247-250,4.
盐酸普鲁卡因注射液在光和热同时作用下的稳定性
Effect of light and heat on the stability of procaine hydrochloride injection
林涛 1李琳丽 1詹先成 1李开兰 1李志毅 1殷恭宽1
作者信息
摘要
Abstract
Objective: To study the effect of both lig ht and heat on drug stability with procaine hydrochloride injection as a model. Methods: The degrada tion of the injection was studied at high temperatures in dark at first, and sub sequently in light. The degradation rate constants k dark, and k light; pre-exponent ial factors A dark, and A light; as well as the observed activation energies Ea ,dark and Ea ,light of the thermal rea ctions were obtained. The experiments in light were performed with a fluorescent mercury-arc lamp or a UV mercury-arc lamp installed at the top of the isothermal heating oven respectively. Results: Under the exposure to both light and hi gh temperatures, the degradation of procaine hydrochloride was caused by both th e rmal and photo reactions. The total degradation rate could be divided into two p ar ts: d A total/d t = k dark A dark n ′+ k light A light n , where A total is the total absorbance of procaine hydrochloride injection, A dark is the absorba nce caused by heat, A light, the one caused by light, all at 440 nm and n is the rate order of the pho to reaction, n ′ is the rate order of the thermal energy reaction. The k light can be expre ssed as: k light= A light*exp(－ Ea ,light/ RT )* E , where E is the illuminance of light． Conclusion: Since the k light equation is simil ar to the Arrhenius equation, it is suggested that Ea ,light be the observed activation energy of th e rate-det ermining step of the subsequent processes of the photochemical reaction. This v iewpoint is supported by the fact that the Ea ,light is independent of light sour ces. According to the rules observed, the shelf-life of procaine hydrochloride injection in indoor daylight at room temperature is predicted.
关键词
光/热/普鲁卡因/药物稳定性分类
医药卫生引用本文复制引用
林涛,李琳丽,詹先成,李开兰,李志毅,殷恭宽..盐酸普鲁卡因注射液在光和热同时作用下的稳定性[J].北京大学学报（医学版）,2001,33(3):247-250,4.
