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[摘要]
目的 优化尼美舒利乳膏剂的处方。方法 选用L9(34)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。
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[Abstract]
Objective To optimize the prescription of Nimesulide Cream. Methods L9(34) orthogonal design was used to optimize the prescription of Nimesulide Cream. Azone, propylene glycol, and peregal O20 were selected as three factors, and each factor formed three levels. Permeation rates were determined with Franz diffusion device in isolated mouse abdominal skin as a barrier. Phosphate buffer (pH 7.4) was used as acceptable medium in (37 ± 1) ℃ water bath with speed of 500 r/min. Results Azone was the main factor affecting the rate of percutaneous absorption, and the following was peregal O20. The optimal conditions were determined by the experimental data, such as 3% azone, 15% propylene glycol, and 1% peregal O20. It could be conclude from the cumulative permeation quantity - time curve that transdermal absorption accorded with Zero order equation. Conclusion The prescription of Nimesulide Cream is reasonable, and the preparation technology is feasible.
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