盐酸普鲁卡因注射液在光和热同时作用下的稳定性

盐酸普鲁卡因注射液在光和热同时作用下的稳定性
林涛;李琳丽;詹先成;李开兰;李志毅;殷恭宽
【期刊名称】《北京大学学报（医学版）》
【年(卷),期】2001(033)003
【摘要】目的：以盐酸普鲁卡因注射液为例, 研究药物在光和热同时作用下的稳定性。

方法：先考察该注射液在高温避光条件下的降解规律, 求出热反应的降解速率常数 k dark,指前因子 A dark和活化能 Ea , dark,再在烘箱内上方分别安装荧光高压汞灯和紫外高压汞灯, 考察其在高温和光照同时作用下的降解规律, 求出光反应的降解速率常数 k light , 指前因子 A light和活化能 Ea , light。

结果：在高温光照试验中,该药物降解速率由两部分构成：d A total/d t = k d ark A dark n′+ k light A light n ,式中 A total为盐酸普鲁卡因注射液在440 nm处的总吸收度, A dark和 A light分别为该药在无光照时热作用下所产生的吸收度和光作用下所产生的吸收度(440 nm), n 为光化反应的级数, n′为热反应的级数。

光化反应速率仍与温度有关: k light= A light*exp(－ Ea ,light/ RT )* E , 式中 E 为光源的照度。

结论：由于 k light的表达式与Arrhenius方程形式类似,式中 Ea ,light可能为光化反应后继过程的表观活化能,由实验得出 Ea ,light值几乎与光源种类无关而支持了这一观点; 根据光和热同时对盐酸普鲁卡因注射液稳定性的影响规律,预测了该药物在室温、室内自然光照射下的贮存期。

%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.
【总页数】4页(P247-250)
【作者】林涛;李琳丽;詹先成;李开兰;李志毅;殷恭宽
【作者单位】四川大学华西药学院物理化学教研室,;四川大学华西药学院物理化学教研室,;四川大学华西药学院物理化学教研室,;四川大学华西药学院物理化学教研室,;四川大学华西药学院物理化学教研室,;四川大学华西药学院物理化学教研室,【正文语种】中文
【中图分类】R913
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