用体外释放度优选硝酸咪康唑缓释凝胶基质的研究

Optimization of the formulation of miconazole nitrate sustained-release gel by release rate in vitro

目的:优选硝酸咪康唑缓释凝胶剂的处方。方法:采用正交设计法,以聚卡波菲、甘油、山嵛酸甘油酯的用量为因素,以累积释放度作为考查指标,对硝酸咪康唑缓释凝胶剂的处方进行优选。结果:优选的凝胶剂最佳处方为聚卡波菲1.5 g、甘油5 mL、山嵛酸甘油酯2.0g。结论:体外累积释放试验筛选硝酸咪康唑凝胶剂处方可行,所得缓释凝胶的质量符合2015年版《中国药典》有关规定。

OBJECTIVE To optimize the formulation of miconazole nitrate sustained-release gel.METHODS The orthogonal design method was adopted.The amounts of polycarbophil,glycerin and compritol 888 ATO were used as analysis factors,and sustained-release was used as test index.RESULTS The optimal formulation of itraconazole gels was polycarbophil of 1.5 g,glycerin of 5 mL,and compritol 888 ATO of 2.0 g.CONCLUSION The method adopted for screening the formulation of the gels is feasible,and the quality meets the requirements of Pharmacopoeia 2015.