摘要
目的:优选消痤乳膏的处方工艺并对其进行初步质量评价.方法:根据消痤方中药物的特点及乳膏基质的特点,筛选处方组成,研究制备工艺,考察乳膏的外观性状肤感和离心、高低温稳定性等指标,筛选最佳处方组成,制备消痤乳膏,进行初步质量评价.结果:优选制剂工艺为:油相中加入乳化剂2 g M68,3 g A165,水相中加入0.15 g卡波姆U20,于85℃将水相缓慢加入油相中,用乳化均质机25 000 r/min均质5 min,边均质边加入中药提取物粉末,40～50℃时加入0.5 g305乳化剂、祛痘复方精油和多元醇抗菌剂即得100 g乳膏.制得乳膏pH为5.5～6.5,粒度＜50 μm;乳膏中芍药苷、黄芩苷、盐酸小檗碱、丹皮酚在各自线性范围内与峰面积呈良好的线性关系,平均加样回收率分别为:100.13%(RSD=2.19%)、99.59%(RSD=1.98%)、98.62%(RSD=2.17%)、101.72%(RSD=2.41%).结论:制得的消痤乳膏,重现性好,乳膏色泽较纯正,均匀细腻,稠度适宜,易涂布、稳定性好,该工艺可作为最佳配比制备消痤乳膏.
Abstract
Objective:To optimize the preparation technology of acne-eliminating cream(Xiaocuo Rugao)and to conduct preliminary quality evalution.Methods:According to the characteristics of acne-eliminating prescription and cream matrix,the best prescription composition was established by screening the composition,studying the preparation process,and investigating the appearance,property,feeling,centrifugation,high and low temperature stability,thus preparing the cream,meanwhile,the preliminary quality evaluation was carried out.Results:The optimized preparation process is as follows:adding 2 g M68 and 3 g A165 emulsifiers to the oil phase,adding 0.15 g carbomer U20 to the water phase,slowly adding the water phase to the oil phase at 85℃,homo-genizing for 5 minutes with an emulsifier homogenizer at 25 000 r/min,and adding traditional Chinese medicine extract powder while homogenizing,At 40-50℃,mixing 0.5 g 305 emulsifier,acne reducing compound essential oil,and polyol antibacterial agent to obtain 100 g cream.The prepared cream has a pH of 5.5 to 6.5 and the particle size of<50 μm;baicalin,baicalin,berberine hydrochloride and paeonol in cream showed the good linear rela-tionship within peak area and their respective linear ranges,and their average recovery rates were 100.13%(RSD=2.19%),99.59%(RSD=1.98%),98.62%(RSD=2.17%),and 101.72%(RSD=2.41%).Conclusion:The prepared cream represents good reproducibility,pure color,fine uniformity,appropriate consistency,easy coating and good stability,and the process could be used as the optimal preparation of the cream.
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