正交试验设计法优选复方利多卡因乳膏的基质处方

Cream formulation optimization of compound lidocaine cream with orthogonal experimental design method

目的优选复方利多卡因乳膏的基质处方。方法采用预试验法确定乳化剂，采用正交试验设计法筛选基质处方，以单硬脂酸甘油酯、白凡士林、甘油、液体石蜡为考察因素，以乳膏的外观性状和稳定性为评价指标，以综合打分的方式确定乳膏的最佳基质处方并进行验证试验。结果复方利多卡因乳膏的最佳基质处方为1000g乳膏中含硬脂酸100g，三乙醇胺20g，单硬脂酸甘油酯50g，自凡士林50g，甘油80g，液体石蜡80g，验证试验综合得分均〉95分，考察指标结果达到要求。结论优选的复方利多卡因乳膏基质处方合理，制剂成品质量稳定。

Objective To optimize the cream formulation of compound lidocaine cream. Methods Preparative test was used to determine the emulsifier, and the cream formulation was optimized with orthogonal experimental design method, with glyc- erol monostearate, white vaseline, glycerol and liquid paraffin as investigating factors, with appearance and stability of the cream as evaluating index. Optimum cream formulation was determined with comprehensive scoring method and verifying test. Results The optimized cream formulation of compound lidocaine cream： in 1 000g cream containing stearic acid 100g, triethanolamine 20g, glycerol monostearate 50g, white vaseline 50g, glycerol 80g,liquid paraffin 80g, and all verifying test scores〉95 points, and the results met the requirements. Conclusion The optimized cream formulation of compound lidocaine cream is reasonable, and the product quality is stable.