处方因素对黄体酮缓释凝胶体外释放性质和黏度的影响  

Effect of composition and preparation procedure of sustained-release progesterone gel on its in vitro release rate and viscosity

作　　者：李鸿滨[1] 丁平田[2] 徐晖[2] 董英杰 艾莉 

机构地区：[1]沈阳药科大学集琦药业有限责任公司,沈阳110016 [2]沈阳药科大学药剂系,沈阳110016 [3]辽宁省医药工业研究院,沈阳110015

出　　处：《中国新药杂志》2004年第2期133-136,共4页Chinese Journal of New Drugs

摘　　要：目的:研究处方的组成和制备工艺对黄体酮阴道凝胶体外释放性质和黏度的影响。方法:用旋转黏度计测定凝胶的动态黏度,凝胶的体外释放度采用自制样品池和标准的药物溶出度仪测定。结果:黄体酮的释放为一级过程;随着聚卡波菲含量增加,凝胶的黏度增大,药物释放速率稍降低;液体石蜡含量增加,凝胶的黏度出现最小值,但药物释放速率无明显变化;凝胶的混合方法和水化时间对黏度和药物释放无明显影响。结论:改变处方组成和药物含量,可以获得具有适宜黏度和药物释放速率的黄体酮缓释凝胶。Objective:To study the effect of composition and preparation procedure of sustained-release progesterone gel on its in vitro release rate and viscosity. Methods:Dynamic viscosity was measured by rotation viscometer and in vitro release rate was measured by standard dissolution apparatus using self-made sample cells. Results: Sustained-release progesterone gel followed first-order drug release model and it was found that the higher the polycarbophil content in the gel the higher the viscosity and the lower the release rate and that increasing paraffin content in the gel can minimize the gel's viscosity but did not affect significantly its release rate. Mixing procedure and hydration time had no significant effect on the gel's viscosity and release rate.Conclusion:Sustained-release progesterone gels with appropriate viscosity and release rate can be obtained through modulating the gel' s composition and progesterone content.

关 键 词：黄体酮 阴道凝胶 药物释放 黏度 

分 类 号：R944.9[医药卫生—药剂学] R977.12[医药卫生—药学]