京尼平苷乳膏的制备和稳定性考察

 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。

Preparation and Stability of geniposide Cream

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 stable and has good transdermal characteristics in vitro,which is a new dosage form for transdermal drug delivery.