复方润燥止痒乳膏的制备及皮肤刺激性评价  

Preparation and Skin Irritation Evaluation of Compound Moistening Dryness Antipruritic Creams

作　　者：龙雄初[1] 刘小虎 张玉平[3] 龙枚飞[1] 张立民[3] LONG Xiongchu;LIU Xiaohu;ZHANG Yuping;LONG Meifei;ZHANG Limin(Emergency Department of the 81st Army Hospital of the PLA,Zhangjiakou,Hebei 075000,China;Department of Pharmacy,Zhangjiakou Hospital of Traditional Chinese Medicine,Zhangjiakou,Hebei 075000,China;Department of Pathophysiology,Basic Medical College,Hebei North University,Zhangjiakou,Hebei 075000,China)

机构地区：[1]中国人民解放军陆军第八十一集团军医院急诊科,河北张家口075000 [2]张家口市中医院药剂科,河北张家口075000 [3]河北北方学院基础医学院病理生理教研室,河北张家口075000

出　　处：《药学与临床研究》2023年第2期132-135,共4页Pharmaceutical and Clinical Research

摘　　要：目的:探讨复方润燥止痒乳膏的制备,并对制剂的皮肤刺激性进行评价。方法:采用正交试验法,选取3个不同剂量的乳膏剂基质制成水包油(O/W)型乳膏剂,以制剂的外观性状、稳定性和保湿性为主要考察指标,优选出最佳处方;利用兔子完整皮肤评价乳膏剂对皮肤的刺激性。结果:优选出的最佳处方外观均匀细腻、有光泽、稠度适宜、稳定性和保湿性好,对完整皮肤无刺激性。最佳处方为1000 g乳膏中含维生素E 20 g、盐酸利多卡因20 g、马来酸氯苯那敏5 g、冰片20 g、荷荷巴油60 g、葡萄籽油60 g、甜杏仁油60 g、人参提取液100 g、甘草提取物10 g、苦参提取物10 g、马齿苋提取物10 g、甘油50 g、硬脂酸55 g、三乙醇胺25 g、聚山梨酯-8030 g、蒸馏水450 mL、95%酒精15 mL。结论:优选的复方润燥止痒乳膏处方合理,所得制剂的外观性状、稳定性、保湿性良好,符合临床应用要求。Objective:To investigate the preparation of compound moistening dryness antipruritic creams and evaluate the skin irritation of the preparation.Methods:Using an orthogonal test,three cream components at three dosage levels were used to produce oil-in-water(O/W)type creams at three temperature levels,with the appearance,stability and moisturity of the preparation as the main parameters for selection of the best prescription.Rabbit intact skins were applied to evaluate the skin irritation of the creams.Results:The compound moistening dryness antipruritic creams had uniform and delicate appearance,luster,appropriate consistency,good stability and moisturizing,and had no irritation to the intact skins.The best prescription of 1000 g compound moistening dryness antipruritic creams contained 20 g vitamin E,20 g lidocaine hydrochloride,5 g chlorphenamine maleate,20 g borneol,60 g jojoba oil,60 g grape seed oil,60 g sweet almond oil,100 g ginseng extract,10 g licorice extract,10 g sophora flavescens extract,10 g purslane extract,50 g glycerol,55 g stearic acid,25 g triethanolamine,30 g polysorbate-80,450 mL distilled water and 15 mL 95%alcohol.Conclusion:The prescription of the optimized compound moistening dryness antipruritic creams is reasonable,and the appearance,stability and moisture retention of the preparation are good,which meets the requirements of clinical application.

关 键 词：复方润燥止痒乳膏 瘙痒症 刺激性 

分 类 号：R943[医药卫生—药剂学]