氢化可的松注射液在光作用下的稳定性研究

The Photostability of Hydrocortisone Injection

目的 用灯光为光源研究药物在自然光照射下的稳定性。方法 采用自制的光量累积仪 ,用脉冲计数法对自然光进行累积计量 ,研究氢化可的松注射液在灯光及自然光照射下的含量变化规律 ;探讨不同光源对该药物稳定性的影响 ;并预测该药物在室内自然光照射下的贮存期。结果 氢化可的松注射液在光照试验中的含量变化遵从零级动力学规律 :C=C0 - k Et;在无外包装条件下 ,室内自然光照射下的贮存期约为 36天 ,与留样测得的结果 35天基本一致。结论 采用灯光照射实验可研究药物在自然光照射下的稳定性。

Objective This experiment was designed to make known wether the photostability of drugs in daylight can be obtained from lamplight exposure. Methods A self made cumulative illuminometer via pulse counting method was used for measuring cumulative illuminance of daylight to investige the photodegradation of Hydrocortisone injection in various lamp light and daylight; the equivalent influences of different light sources on the photostability of the injection were obtained,and the shelf life in indoor daylight of the drug was predicted. Results The photodegradation of Hydrocortisone injection obeys zero order kinetics: C=C 0-kEt; the shelf life in indoor daylight of the injection in nude ampoules was predicted as 36 days and is comparable to 35 days in a long term storage test. Conclusion The photostability of drugs in daylight can be obtained from lamplight exposure experiment.