目的 确定阿司匹林软膏剂的最佳处方。方法 以6 h累积渗透量和皮肤刺激性为考察指标,选择阿司匹林软膏处方中对指标影响较显著的3个因素:十二烷基硫酸钠、枸橼酸三钠、三乙醇胺为考察对象,采用中心组合设计法对阿司匹林软膏处方进行优化。结果 阿司匹林软膏的最佳处方是:十二烷基硫酸钠1.41%,枸橼酸三钠3.50%,三乙醇胺3.00%。按照优化处方制备了3批阿司匹林软膏样品,其6 h平均累积渗透量为990.18 μg·cm-2,产品无明显刺激性。结论 中心组合设计法应用简便、预测性好,制备的阿司匹林软膏符合设计要求。
Abstract
OBJECTIVE To optimize the formulation of aspirin ointment. METHODS With cumulative permeation quantity within 6 h and shin irritation as indexes, the method of central composite design was used to optimize the formulation of aspirin ointment, taking the most important three ingredients including sodium lauryl sulfate(X1), sodium citrate (X2)and triethanolamine(X3)as the study subjects. RESULTS The optimized formulation of aspirin ointment was composed of 1.41% sodium lauryl sulfate, 3.5% sodium citrate and 3.0% triethanolamine. Three batches of aspirin ointment were prepared using the optimized formulation, for which the average cumulative permeation quantity within 6 h was 990.18 μg·cm-2, and no obvious shin irritation was observed. CONCLUSION Central composite design is successfully used to optimize the formulation of aspirin ointment.
关键词
阿司匹林软膏 /
中心组合设计法 /
处方优化
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Key words
aspirin ointment /
central composite design /
prescription optimization
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中图分类号：
R944
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参考文献
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脚注
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基金
国家自然科学基金资助项目(81202479);教育部重点项目(212148);泸州医学院重点项目
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