摘要
目的制备壬苯醇醚阴道用缓释凝胶并优化其处方与工艺。方法采用正交试验设计 ,考察了聚卡波菲用量、卡波沫用量、pH值、甘油用量、液体石蜡用量、山嵛酸甘油酯用量及不同工艺对释放度的影响 ,与国外产品进行残差平方和、拟合度、区分因子和相似因子比较 ,确定壬苯醇醚阴道用缓释凝胶的处方工艺 ,并考察了其初步稳定性。结果优化所得处方工艺为 :聚卡波菲用量0 5 % (w) ,卡波沫用量 1% (w) ,甘油用量为 5 % (w) ,液体石蜡用量为 5 % (w) ,山嵛酸甘油酯用量为 1% (w) ,pH值为 4 5 ,选用工艺 1。 结论按优化处方工艺制得的壬苯醇醚阴道用缓释凝胶稳定 ,与国外产品比较具有相似的释放度 ,且以复合模式释放。
Objective To optimize the preparation and formulation of nonoxynol-9 suatained-release gel for vagina.Method The orthogonal design was used to screen the preparation and formulation of nonoxynol-9 sustained-release gel for vagina which took SUM,r2,difference factor and similarity factor compared with a similar product as index on the base of the influence of pH,preparation and the amount of Polycarbophil,Carbopol,glycerol,liquid paraffin and Compritol 888 ATO on drug release.Result The optimal combination of preparation and formulation is 0.5%(w) polycarbophil,1.0%(w) carbopol,5%(w) glycerol,10%(w) liquid paraffin and 1%(w) Compritol 888 ATO,pH 4.5 and preparation method 1.Conclusions The optimized preparation and formulation of nonoxynol-9 sustained-release gel for vagina has the properties of preliminarily steady and similar release with a foreign product.
出处
《沈阳药科大学学报》
CAS
CSCD
2004年第4期245-249,共5页
Journal of Shenyang Pharmaceutical University
关键词
壬苯醇醚
凝胶剂
阴道给药系统
正交设计
释放度
nonoxynol-9
gels
vaginal drug delivery systems
orthogonal design
drug release in vitro
