阿奇霉素分散片制备工艺研究

Preparation of azithromycin dispersible tablets

目的:优化阿奇霉素分散片制备工艺。方法:以片剂的硬度、溶出度、分散均匀度及外观为综合考察指标,建立了一个优化的处方工艺,并对其稳定性进行考察。结果:选用黏合剂浓度为6.0%(w/w),黏合剂用量为45%(w/w),配制乙醇浓度30%(w/w),液体香精为1.3%(w/w)的处方,效果最佳。结论:该工艺研制的阿奇霉素分散片质量指标符合药典要求,生产工艺稳定。

Objective： To optimize the process for the preparation of azithromycin dispersible tablets. Methods： In order to confirm the best formulation, we checked the hardness, dissolution, dispersible homogeneity and appearance of the tablets and their stability. Results： The best formula consisted of the binder at 6.0%（w/w）, the amount of the binder at 45%（w/w）, the ethanol at 30%（w/w） and the liquid essence of 1.3% （w/w）. Conclusion： The quality indicators of the azithromycin dispersible tablets prepared by this process meet the requirements of Chinese pharmacopoeia and the process for their production is stable.