樟脑薄荷柳酯乳膏处方改良及稳定性考察

发布时间：2018-02-27 15:22

本文关键词： 樟脑薄荷柳酯乳膏处方改良水杨酸甲酯稳定性有效期有关物质工艺优化　出处：《中国医药工业杂志》2017年06期 　论文类型：期刊论文

【摘要】：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。
[Abstract]:In view of the decrease of methyl salicylate content in camphor menthol ointment, the dosage of glycerol polyethylene glycol 75 stearate (Gelot 64), carbomer Carbopol 980) and the ratio of di#china_person0# hydroxyl toluene (BHT) to disodium idate were investigated. Based on the comprehensive score of the decline of cream properties, viscosity and methyl salicylate content, the formulation was optimized by orthogonal test, and then the phenomenon of stratification was studied. The accelerated stability of the optimized prescription was investigated from the four aspects of the content and the related substances. The optimum formulation was as follows: Gelot 64 12 g per 100g cream, carbomer 0.8 g, triethanolamine 1 g, disodium idate 0.02 g, hydroxyphenylethyl 0.1 g. Compared with the original prescription, the modified cream had a more delicate appearance. The stability of methyl salicylate content was obviously improved.
【作者单位】：广东华润顺峰药业有限公司;
【分类号】：R943

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