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。
Abstract
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.
关键词
京尼平苷 /
乳膏 /
制备工艺 /
稳定性
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Key words
geniposide /
cream /
preparation technology /
stability
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中图分类号:
R944
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参考文献
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脚注
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