新生儿用地西泮栓剂的稳定性考察

Study on the Chemical Stability of Diazepam Suppositories of Neonats

目的 研究新生儿用地西泮栓剂的稳定性。方法 用反相高效液相色谱法测定地西泮含量 ,通过初均速法对地西泮栓剂作稳定性实验 ,并与留样观察作对照。结果 地西泮栓剂的热解反应活化能为 2 3 .0 75 kcal· mo L- 1 ,室温 (2 5℃ )贮存期为 3 43 d,与留样观察 3 60 d结果也基本相符。 结论 初均速法测定新生儿用地西泮栓剂的稳定性方便可行。

OBJECTIVE To study on the chemical stability of diazepam suppositories of neonats. METHODS The concentration of diazepam suppositories of neonats were determined with RP-HPLC. Initial average rate method was applied to test the stability of diazepam suppositories which was compared with samples reserved for observing .RESULTS The activation energy for pyrolytic reaction of diazepam suppositories of neonats was 23.075kcal·moL -1 ,the shelfifes of the drug at room temperature(25℃)was 343days , 360days determined by other method respectively.CONCLUSION Initail average rate method is a simple way to determine the stability of the drug.