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目的采用星点设计法以经皮累计渗透量为指标优化氟比洛芬纳米结构脂质载体凝胶剂的处方。方法以经皮累积渗透量为评价指标,考察了凝胶基质量(x1)、氮酮用量(x2)和丙二醇用量(x3)对氟比洛芬纳米结构脂质载体凝胶剂性质的影响。用多元线性方程和二次多项式描述经皮累积渗透量和3个影响因素之间的数学关系,根据经皮累积渗透量的最佳数学模型描绘效应面,选择最佳处方,并进行预测分析。结果三个影响因素和经皮累积渗透量之间存在定量关系。优选的最佳处方:卡波姆940为0.15 g、氮酮为0.70 g,丙二醇为1.50 g。优化处方各指标的预测值和目标值接近。结论所建立的模型预测性良好,可用于预测和优化氟比洛芬纳米结构脂质载体凝胶剂处方。
OBJECTIVE: To optimize the formulation of flurbiprofen nanostructured lipid carrier gel by the method of star point design using percutaneous cumulative permeation as an indicator. Methods Percutaneous cumulative osmolality was used as evaluation index to investigate the effect of gel permeation volume (x1), azone dosage (x2) and propylene glycol dosage (x3) on the gel properties of flurbiprofen nanostructured lipid carriers. Multivariate linear equations and quadratic polynomials were used to describe the percutaneous cumulative penetration and the mathematical relationship between the three influencing factors. The optimal mathematic model depicting percutaneous cumulative permeation was used to characterize the effect surface, select the best prescription and make predictive analysis. Results There was a quantitative relationship between the three influencing factors and percutaneous cumulative permeation. Preferred preferred prescriptions are: Carbopol 940 0.15 g, Azone 0.70 g, Propylene Glycol 1.50 g. The predicted value and the target value of each index of optimized prescription are close. Conclusion The established model has good predictability and can be used to predict and optimize the formulation of flurbiprofen nanostructured lipid carrier gel.