樟脑薄荷柳酯乳膏处方改良及稳定性考察

Formulation Improvement and Stability of Camphor, Menthol and Methyl Salicylate Cream

针对樟脑薄荷柳酯乳膏在有效期内水杨酸甲酯含量下降的问题,以甘油聚乙二醇75硬脂酸酯(Gelot 64)用量、卡波姆(Carbopol 980)用量以及二丁基羟基甲苯(BHT)与依地酸二钠的比例为考察因素,以乳膏性状、黏度、水杨酸甲酯含量降幅的综合评分为指标,用正交试验优化产品处方,继而从性状、分层现象、含量以及有关物质4个方面考察了优化处方的加速稳定性。结果表明,最优处方为每100 g乳膏中含Gelot 64 12 g、单双硬脂酸甘油酯7.5 g、BHT 0.02 g、卡波姆0.8 g、三乙醇胺1 g、依地酸二钠0.02 g、羟苯乙酯0.1 g。改良后的乳膏与原处方制品相比,外观更加细腻,水杨酸甲酯含量的稳定性得到明显改善。

To solve the problem of methyl salicylate content decrease in camphor, menthol and methyl salicylate cream during the shelf life, the amounts of glyceryl stearate PEG-75 （Gelot 64） and carbomer （Carbopol 980） and the ratio of butylated hydroxytoluene （BHT） to edetate disodium were optimized by orthogonal design with appearance, viscosity of the cream and content decline of methyl salicylate as the indexes. The accelerated stability of the optimal product was investigated with appearance, delamination, contents and related substances as the indexes. The results showed that the optimal formulation should contain 12 g of Gelot 64, 7.5 g of mono- and di-stearin, 0.02 g of BHT, 0.8 g of Carbopol 980, 1 g of triethanolamine, 0.02 g of edetate disodium and 0.1 g of ethylparaben per 100 g of the cream.Compared with the original product, the improved cream was more smooth and the content of methyl salicylate were more stable.