中国药房2009,Vol.20Issue(31):2437-2439,3.
阿奇霉素缓释阴道栓的处方优化
Optimization of the Formulation of Azithromycin Sustained-release Vaginal Suppository
摘要
Abstract
OBJECTIVE: To optimize the formulation of azithromycin sustained-release vaginal suppository(ASVS). METHODS: The ASVS was prepared using S -40 as suppository base, HPMC as sustained-release material and glycerine as humectant. The formulation of ASVS was optimized by orthogonal design with accumulated release percentage and hardness as indexes and the amount of 8% HPMC and glycerol as factors; meanwhile, a verification test and the fitting of in vitro drug release model were performed. RESULTS: The optimized formulation ASVS was as follows: azithromycin 6 g, 8% HPMC 23.52 g,glycerol 29.40 g, ethanol absolute 3 g, ethylparaben 0.59 g, and S-40 294 g. Three batches of suppositories prepared under the optimized formulation reached a mean content of 99.5% , with hardness up to the standard, showing good repro-ducibility and homogenicity in drug release in vitro. The accumulative release rates of all samples were greater than 98% at 180 min, and the release dynamics in vitro were in line with Higuchi equations. CONCLUSION: The optimized ASVS is feasible in formulation, stable and reproducible in preparation technology and up to the standard for sustained-release preparation.关键词
阿奇霉素/缓释阴道栓/正交设计/处方优化/体外释药Key words
Azithromycin/ Sustained-release vaginal suppository/ Orthogonal design/ Optimization of formulation/ In vitro drug release分类
医药卫生引用本文复制引用
赵泉,梁延平,霍雪臣,程东升..阿奇霉素缓释阴道栓的处方优化[J].中国药房,2009,20(31):2437-2439,3.基金项目
烟台市科学技术发展计划项目(2008602) (2008602)