阿奇霉素分散片制备工艺研究.doc

阿奇霉素分散片制备工艺研究
摘要目的: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:%(w/w),黏合剂用量为45%(w/w),配制乙醇浓度30%(w/w),% (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。
关键词阿奇霉素分散片工艺优化
中图分类号: 文献标识码:A 文章编号:1006-1533(2013)21-0048-04
Preparation of azithromycin dispersible tablets
TAN Yueyao*, LIN Youmiao
(Shenzhen Salubris Pharmaceuticals Co., Ltd., Shenzhen 518102, China)
ABSTRACT 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 %(w/w), the amount of the binder at 45%(w/w), the ethanol at 30%(w/w) and the liquid essence of % (w/w). Conclusion: The quality indicators of the azithromycin dispersible tablets prepared by this process meet the requirements of Chinese pharmacopoeia and the p
rocess for their production is stable.
KEY WORDS azithromycin; dispersible tablets; process optimization
阿奇霉素属于大环内酯类抗生素,相比第一个大环内酯类抗生素红霉素,阿奇霉素增强了在酸中的稳定性,改善了口服给药的生物利用度[1],适用于敏感菌所致的呼吸道、皮肤软组织感染和衣原体所致的性传播性疾病。对流感嗜血杆菌、淋球菌的作用比红霉素增强4倍,且国外已有研究用于抗疟原虫感染[2]。分散片由于服用方便,崩解、溶出迅速和生物利用度高的特点而比一般片剂有明显的优越性,特别适用于吞服困难的患者,且口感好,能提高患者的依从性[3]。
由于传统的片剂辅料难以达到分散片快速崩解的要求,处方及崩解剂的选择很重要,文献报道的阿奇霉素分散片选择的辅料包括:微晶纤维素