伊曲康唑阴道用温度敏感原位凝胶的制备及性能研究

Central South Pharmacy(2014)

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Abstract
目的:研制伊曲康唑阴道用温度敏感原位凝胶并考察其性能。方法以伊曲康唑(ITZ)为模型药物,泊洛沙姆为基质采用冷溶法制备伊曲康唑阴道用温度敏感原位凝胶(TISG)。采用试管倒转法测定胶凝化温度(Tg),星点设计-效应面法优化ITZ-TISG处方工艺,旋转流变仪测定其流变学特性。并采用无膜溶出法考察ITZ-TISG溶蚀释药特性。结果通过星点设计-效应面法筛选出最佳处方为16.3%泊洛沙姆407、1.5%泊洛沙姆188、0.31%海藻酸钠。采用试管倒转法测得最优处方所制备的ITZ-TISG的Tg为25℃,经模拟阴道液稀释后的Tg为35℃,与流变仪测得的结果基本一致。在35℃时,ITZ-TISG经阴道模拟液稀释后仍具有较强的黏弹特性。ITZ-TISG的体外溶蚀释药符合零级动力学模型。结论星点设计-效应面法优化ITZ-TISG处方所建立的模型具有良好的预测性。所优化的ITZ-TISG在给药时流动性好,给药后可在阴道生理温度下快速胶凝形成原位凝胶,并具有缓慢溶蚀释放药物的特性,可满足阴道用药设计要求。
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Key words
itraconazole,poloxamer,thermosensitive in situ gel,central composite design-response surface method,rheology,gel erosion and drug release in vitro
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