京尼平苷乳膏的制备和稳定性考察  

Preparation and Stability of geniposide Cream

作　　者：孙敏捷[1] 游伟良[1] 张杰[1] 曹维[2] 施华平[3] 

机构地区：[1]中国药科大学药学院药剂教研室,南京211198 [2]国家知识产权局专利局专利审查协作江苏中心,江苏苏州215011 [3]南京中医药大学基础医学院,南京210046

出　　处：《中国药学杂志》2013年第6期455-460,共6页Chinese Pharmaceutical Journal

基　　金：江苏省中医药管理局科研项目(LB09015)

摘　　要：目的制备京尼平苷乳膏并考察稳定性。方法利用正交试验设计法筛选适宜基质,筛选了不同的促渗剂、防腐剂制成o/w型的乳膏,采用Franz扩散池对纳米乳的体外透皮特性进行了考察,然后对乳膏的流变学和稳定性进行考察。结果最终处方结果是油相体积分数占33%、乳化剂用量为6%、防腐剂用量为0.3%、京尼平苷占0.5%,乳化温度为80℃。此条件制备的乳膏色泽均匀、质地细腻、渗透性良好、便于涂布;12 h累积渗透量为(212.73±22.76)μg·cm-2。药品在常温(25℃)下连续放置6个月,高温(40℃)和低温(4℃)放置3个月,京尼平苷含量和制剂pH值均符合规定。结论京尼平苷乳膏渗透性良好,性质稳定可靠,可以作为京尼平苷经皮给药新剂型。OBJECTIVE To prepare an o/w type geniposide cream and to investigate its stability. METHODS Appropriate base was selected by uniform design; suitable preservative and penetration enhancer were chosen according the characteristics of the cream. Franz diffusion cell was used to evaluate the transdermal characteristics in vitro; the stability and rheology of the cream were evaluated. RESULTS The optimum matrix was composed of oil phase of volume faction 33%, emulsifying agent 6%, and preservative 0. 3%. The content of geniposide was 0. 5%. The emulsifying temperature was 80 ℃. The cream was uniform in color, homogeneous, exquisite and easy to spread; 12 h cumulative penetration amount was （212.73 ±22.76）μg·cm^-2 The contents and pHs of three batches of samples were in accordance with the quality standard after storage at 40 ℃, 25 ℃ and 4 ℃ for 3 months. CONCLUSION Geniposide cream is very st＇able and has good transdermal characteristics in vitro, which is a new dosage form for transdermal drug delivery.

关 键 词：京尼平苷 乳膏 制备工艺 稳定性 

分 类 号：R944[医药卫生—药剂学]