康肤霜处方改良及稳定性考察  

Formulation Improvement and Stability Study of Kangfu Cream

作　　者：刘迪丰[1] 阳玉竹 蔡林[1] 

机构地区：[1]解放军第181医院药剂科,广西桂林541002 [2]河北联合大学冀唐学院,河北唐山063300

出　　处：《中国药房》2015年第34期4850-4852,共3页China Pharmacy

摘　　要：目的:改进康肤霜乳膏处方,以提高其稳定性。方法:针对康肤霜中氧化锌的破乳及乳膏稳定性差的问题,以油相比例(硬脂酸-白凡士林-单硬脂酸甘油酯)和聚山梨酯80、三乙醇胺、聚氧乙烯(10)硬脂酸酯(SG-10)的用量为因素,以乳膏的光泽度、细腻度、稠度、涂布性、分层现象的综合评分(满分10分)为指标,用正交试验优化乳膏处方,验证并考察其配伍、耐热、耐寒、光照等稳定性。结果:最优处方为每100 g乳膏中含硬脂酸8 g、白凡士林8 g、单硬脂酸甘油酯6 g、聚山梨酯80 4 g、三乙醇胺3 g、SG-10 2 g和水适量;所制乳膏的综合评分>9.5分(n=3)。与原处方成品比较,改良后新品外观无明显变化,未见破乳、分层现象,无颜色变化。结论:成功制得稳定性优于原处方的康肤霜乳膏。OBJECTIVE：To improve the formulation of Kangfu cream,in order to increase the stability of it. METHODS：According to the problem that demulsion of zinc oxide and poor stability of Kangfu cream,orthogonal test was used to optimize the formulation of cream matrix with oil phase ratio（stearic acid-white vaseline-glycerol monostearate）,with the amount of polysorbate 80,triethanolamine and SG-10 as factors,using comprehensive score of glossiness,delicacy,consistence,coating and stratification（10 points as full mark）as index. The stability of the cream was validated and investigated,such as compatibility,heat-resisting,cold-resistant,lighting. RESULTS：The formulation were as follows as 100 g cream containing stearic acid 8 g,white vaseline 8 g,glycerol monostearate 6 g,polysorbate 80 4 g,triethanolamine 3 g,SG-10 2 g and appropriate amount of water. The comprehensive scores of the cream were 〉9.5 points（n=3）. Compared with the cream prepared by previous formulation,the cream prepared by modified formulation had no significant change in appearance and color,and demulsion and layering hadn＇t been found. CONCLUSIONS：Kangfu cream with better stability than original formulation is successfully prepared.

关 键 词：康肤霜 处方改良 稳定性 正交试验 

分 类 号：R943[医药卫生—药剂学]