摘要
以HPMC和卡波姆为骨架缓释材料,采用正交实验设计方法,通过累积释放度综合评分进行评价,最终确定克林霉素磷酸酯阴道缓释片的处方组成为:克林霉素磷酸酯119 g(相当于克林霉素100 g),HPMC K4M 350 g,卡波姆934160 g,乳糖113.5 g,硬脂酸镁7.5 g。自研缓释片释放度符合中国药典要求,且体外释放行为符合Higuchi模型和Ritger-Peppas方程,表明药物释放机制是扩散与溶蚀并存的双重机制。
Using comprehensive score of the cumulate release rate as response value , orthogonal experimental design were used to determine the dosage of HPMC K 4 M with Carbomer 934 as matrix materials.The optimal formulation （1 000 units） was Clindamycin Phosphate 119 g （ Equivalent to Clindamycin 100 g）, HPMC K4M 350 g, Carbomer 934 160 g, Lactose 113.5 g and magnesium stearate 7.5 g.The dissolution rate of clindamycin phosphate vaginal sustained-release tablets met the requirements of CP 2010 and release behavior in vitro fitted to the Higuchi model and Ritger-Peppas equation , and the release mechanism in vitro was diffusion combined with corrosion.
出处
《广州化工》
CAS
2014年第14期56-59,共4页
GuangZhou Chemical Industry
基金
十二五国家"重大新药创制"科技重大专项项目
合肥医工医药创新药物孵化基地建设(No:2012ZX09401006)
