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目的采用星点设计-效应面法优化叶黄素温敏凝胶处方,并对其体外释放行为进行考察。方法以胶凝温度为评价指标,考察泊洛沙姆407(P407)和泊洛沙姆188(P188)用量对胶凝温度的影响,使用星点设计-效应面法进行优化,再通过无膜溶出法考察凝胶溶蚀及药物释放。结果 P407及P188用量两个影响因素与胶凝温度之间存在定量关系,最佳处方:P407质量浓度为0.21 g·m L-1,P188质量浓度为0.03 g·m L-1,凝胶溶蚀及药物释放符合零级动力学方程。结论所建立的模型预测性良好,可用于叶黄素原位凝胶处方的预测及优化。
OBJECTIVE: To optimize the prescription of lutein thermo-sensitive gel by using the star-point design-response surface method and investigate its in vitro release behavior. Methods The gelation temperature was used as an index to evaluate the effect of poloxamer 407 (P407) and poloxamer 188 (P188) on the gelation temperature. The method was optimized by apical design-response surface method Method to investigate gel dissolution and drug release. Results There was a quantitative relationship between P407 and P188 dosage and gel temperature. The best prescriptions were P407 concentration of 0.21 g · m L-1, P188 concentration of 0.03 g · m L-1, gel dissolution And drug release in line with zero-order kinetic equation. Conclusion The established model has good predictability and can be used to predict and optimize the prescription of lutein in situ gel.