对乙酰氨基酚口服溶液的处方改进  

Optimization on formulation of oral solution of paracetamol

作　　者：李海兵[1] 谢彦兵[1] 何杨虎 李宝国 刘永学[4] 

机构地区：[1]解放军第一八四医院药械科 [2]江西天施康中药股份有限公司技术部 [3]解放军96163部队 [4]军事医学科学院放射与辐射医学研究所药理毒理室

出　　处：《国际药学研究杂志》2013年第5期634-636,共3页Journal of International Pharmaceutical Research

摘　　要：目的改进对乙酰氨基酚口服溶液的处方,得到稳定、质量合格的制剂。方法优选对乙酰氨基酚口服溶液的溶媒、色素、矫味剂,及最佳配比。采用优化处方制备4批制剂,均澄清、质量合格。然后对其进行稳定性加速实验6个月,再进行质量检查。结果对乙酰氨基酚口服溶液的最佳制备处方为:丙二醇240 ml,甘油60 ml,组合玫瑰红天然色素0.05 ml,柠檬酸缓冲盐(pH=6)适量。结论该处方设计合理,所得制剂稳定且口感好,适合生产。Objective To obtain a stable and qualified oral solution of paracetamol by optimizing the formulation. Methods Firstly, the solvent, pigmentum, flavoring agent and the best proportion of oral liquid of paracetamol were optimized, then four batches of clear and good-quality preparation were obtained using the optimized formulation. At last, the quality of the four batches of preparation were tested after six months accelerated test. Results The optimized formulation of preparing the oral solution of paracetamol was 240 ml 1,2-propancdiol, 60 ml glycerol, 0. 05 ml combined pigment phloxine and appropriate amount of citric acid buffer salt（ pH = 6）. Conclusion The optimized formulation was reasonable and suitable for manufacture, and the preparation was stabilized and well-tasted.

关 键 词：对乙酰氨基酚口服溶液 处方 稳定性 含量 

分 类 号：R944[医药卫生—药剂学]