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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。
Objective: To study the prescription and preparation process of compound tramadol injection and to investigate its stability. Methods: The contents of tramadol, nefopam and pH value were used as screening indexes to screen prescription and preparation process. The stability of three batches of samples was also investigated. Results: The optimal pH value was 5.0-6.0. Three batches of samples were tested for six months after accelerated test. Samples were taken at room temperature for 24 months and were of stable quality. Conclusion: The prescription is reasonable, the technology is feasible and the quality is stable.