克班宁注射剂制备工艺的初步研究

Study on Optimum Preparation Process for Crebanine Injection

目的制备性质稳定的克班宁注射剂,优选最佳制备工艺。方法采用正交试验法,以可见分光光度法对其色泽变化进行考察。结果配制0.25%克班宁注射剂的最佳工艺为:以盐酸为成盐用酸,pH为4.4,NaHSO3为抗氧剂,熔封通CO2且避光保存。以该法配制的克班宁注射剂沸水加热6h,强光照射12h,色泽无变化。结论按上述方法配制的克班宁注射剂稳定性较好。

Objective To make stable crebanine injection. Methods The color change was determined by spectrophotometry. The optimum preparation process was selected with the L8(27) orthogonal design. Results The best preparation process to make 0.25% crebanine injection was obtained adding HCl to pH=4.4, adding NaHSO3 as antioxidant, and CO2 to protect crebanine from being oxidized, storing where could advoid light. The crebanine injection made in this way can stain the original color even had been heated in boiling water for 6 hours and been irradiated 12 hours by strong light. Conclusion The crebanine injection made in the way mentioned above can obtained better stability.