药学学报, 2011, 46(5): 586-591
引用本文:
肖 璐 易 涛 刘 颖 宦 娣 何吉奎. 效应面法优化新型自微乳化口腔速溶膜[J]. 药学学报, 2011, 46(5): 586-591.
XIAO Lu, Yi- Chao, Liu- Ying, Huan- Di, He-Ji-Kui. Optimization of novel self-microemulsifying mouth dissolving films by response surface methodology[J]. Acta Pharmaceutica Sinica, 2011, 46(5): 586-591.

效应面法优化新型自微乳化口腔速溶膜
肖 璐1, 易 涛1, 2*, 刘 颖1, 宦 娣1, 何吉奎1
(1. 西南大学药学院, 重庆 400715; 2. 澳门科技大学澳门药物及健康应用研究所, 澳门 000853)
摘要:

本文研制了一种顺应性强且可提高水难溶性药物口服生物利用度的新剂型——自微乳化口腔速溶膜。采用Box-Behnken设计效应面法对其处方进行优化, 考察处方中固体载体微晶纤维素、低取代羟丙基纤维素、羟丙甲基纤维素的用量对体外崩解时间、体外释放度、形成微乳后的粒径及抗拉伸性的影响。筛选最优处方制得的口腔速溶膜崩解时间为 (17.09 ± 0.72) s, 形成微乳粒径为 (28.81 ± 3.26) nm, 体外2 min时释放率为(66.18 ± 1.94)%。本剂型服用方便, 口腔中迅速自微乳化, 药物释放快速, 抗拉伸性强, 具有广阔的应用前景。

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Optimization of novel self-microemulsifying mouth dissolving films by response surface methodology
Abstract:

This paper report the development of a new dosage form self-microemulsifying mouth dissolving films, which can improve the oral bioavailability of water insoluble drugs and have good compliance.  A three factor, three-level Box-Behnken design was used for optimizing formulation, investigated the effect of amounts of microcrystalline cellulose, low-substituted hydroxypropyl cellulose and hypromellose on the weight, disintegration time, cumulative release of indomethacin after 2 min, microemulsified particle size and stretchability.  Optimized self-microemulsifying mouth dissolving films could fast disintegrate in (17.09 ± 0.72) s; obtain microemulsified particle size at (28.81 ± 3.26) nm; and release in vitro at 2 min to (66.18 ± 1.94)%.  Self-microemulsifying mouth dissolving films with broad application prospects have good compliance, strong tensile and can be released rapidly in the mouth through fast self-microemulsifying.

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