【摘要】 目的:研究复方曲马多注射液的处方及制备工艺,并进行稳定性考察。方法:以曲马多、奈福泮含量、pH值为考察指标,筛选处方及制备工艺;并考察3批样品的稳定性。结果:最适pH值为5.0~6.0,制备的3批样品经加速试验6个月、室温留样24个月考察,质量稳定。结论:处方合理,工艺可行,质量稳定。更多还原

【Abstract】 Objective: To establish a reasonable formulation and preparing technique of compound tramadol injection and inspect its stability. Method: The content and pH value were served as the inspecting indexes to design the formulation and preparation technique.The stability of 3 batches of sample was inspected. Result: The optimum pH was 5.0～ 6.0 and the preparation was stable after 6 months of acceleration test and 24 months of storage at room temperature. Conclusion: The injection was rational in formulation, feasible in preparation technique,and stable in quality.更多还原