地塞米松萘普生复方乳凝胶基质的处方优化

目的优化地塞米松萘普生复方乳凝胶基质处方。方法以外观评定、离心稳定性、耐热耐寒、热循环、光加速和留样观察等试验的综合加权评分作为考察指标,采用单因素试验设计法及正交试验设计法优化卡波姆、蓖麻油、甘油、吐温-80的配比。结果对于乳凝胶质量,蓖麻油的影响最大,其次是卡波姆和甘油,吐温-80的影响不大;优化的基质处方为卡波姆用量1.0%、蓖麻油用量10%、甘油用量10%、吐温-80用量1.0%。结论按优化后的基质处方制备的地塞米松萘普生复方乳凝胶基质兼有乳剂和凝胶的特性,质量稳定,符合药用标准。

Optimization of Matrix Formulation of Compound Dexamethasone Acetate and Naproxen Gel

Objective To optimize the matrix formulation of compound dexamethasone acetate and naproxen gel. Methods Asingle-factor experiment and orthogonal design were applied to optimize the optimum ratio of carbomer, castor oil, glycerin, tween-80 with the comprehensive weight score of appearance assessment, centrifugal stability, abilities to endure hotness and coldness, heat recycling, light acceleration and sample observation as an index. Results Castor oil had greatest effect on quality of gel, followed by carbomer and glycerin, while tween-80 had no evident effect. The optimum matrix formulation was 1.0% carbomer, 10% castor oil, 10% glycerin,and 1.0% tween-80. Condusion Compound dexamethasene acetate and naproxen gel produced by means of optimum matrix formulation is featured by specific characteristics of gel and emulsion, and its quality is stable, conforms to the criteria of medical use.