复方苦参水杨酸乳膏剂的制备及皮肤刺激性评价

Preparation and Irritations of Quality of Compound Sophora flavescens and Salicylic Acid Creams

目的制备复方苦参水杨酸乳膏剂,并对制剂皮肤刺激性进行评价。方法以释药速率为指标,采用凝胶扩散法确定乳膏剂的类型;在单因素考察的基础上,以稳定性为主要考察指标,采用正交设计法,优化乳膏剂的基质处方;选取兔子完整皮肤和破损皮肤,评价乳膏剂对皮肤的刺激性。结果琼脂扩散法表明,乳膏剂类型为O/W型,释药速率最快;当基质中三乙醇胺2g,十二烷基磺酸钠1g,甘油8.5ml时,乳膏剂外观细腻,稳定性最好;刺激性实验结果表明乳膏剂对完整皮肤和破损皮肤均无刺激性。结论复方苦参水杨酸乳膏剂未见报道和上市,该复方软膏制备可行,扩大了用于治疗足癣的制剂品种的选择范围。

Objective To prepare compound Sophora flavescens and salicylic acid ointment creams and evaluate quality of creams preliminarily.Methods Taking drug release rate as the indicator,the type of creams was confirmed by using gel diffusion methods;Based on single factors,prescriptions of matrix were optimized by orthogonal design,using stability as the index; skin irritations of creams were evaluated by choosing integral and broken skins of rabbits.Results Agar diffusion methods shows that drug release rate is fastest,when creams type is oil-in-wate; when triethanolamine is 2 g,sodium dodecyl sulfate is 1 g and glycerinum is 8.5 ml,the stability of creams is best; irritations test shows that creams have no irritations to integral and broken skins.Conclusion Compound Sophora flavescens and salicylic acid ointment creams aren＇t reported and appear.This preparation technology is feasible and enlarge selection range of preparations in order to treat tinea pedis.