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目的优化尼美舒利乳膏剂的处方。方法选用L9B(3P4P)正交设计对尼美舒利乳膏的处方进行优化筛选,选氮酮、丙二醇和平平加O20为3个影响因素,每个因素各取3个水平,用药物透皮扩散试验仪,以离体小鼠腹部皮肤为屏障,pH 7.4磷酸盐缓冲液为接受介质,(37±1)℃恒温水浴,转速500 r/min,测定不同处方的渗透速率。结果氮酮是影响透皮吸收速率的主要因素,其次是平平加O20。最佳工艺条件是氮酮3%、丙二醇15%、平平加O20 1%。从累积渗透量–时间曲线方程可以看出,透皮吸收符合零级方程。结论尼美舒利乳膏剂的处方合理,制备工艺可行。
Objective To optimize the formulation of nimesulide cream. Methods Orthogonal design of L9B (3P4P) was used to optimize the prescription of nimesulide cream. Three factors, azone, propanediol and paclitaxel, were selected as the three influencing factors. Each factor was taken as 3 levels. Diffusion tester was used to screen the abdominal skin of mice in vitro. The pH 7.4 phosphate buffer solution was used as the mediator, and the speed was changed to 500 r / min at a constant temperature of 37 ± 1 ℃. The permeation rate of different prescriptions was determined. Results Azone is the main factor affecting transdermal absorption rate, followed by flat plus O20. The best conditions are azone 3%, propylene glycol 15%, flat plus O20 1%. It can be seen from the equation of cumulative infiltration-time curve that transdermal absorption conforms to the zero-order equation. Conclusion Nimesulide cream prescription is reasonable, the preparation process is feasible.