康肤霜制剂的稳定性考察  

Stability Study of Kangfu Cream

作　　者：陈兰 吴雪 CHEN Lan;WU Xue(Wuzhou Vocational College,Wuzhou 543000,China;不详)

机构地区：[1]梧州职业学院,广西梧州543000 [2]中国人民解放军联勤保障部队第九二四医院,广西桂林541002

出　　处：《中国处方药》2022年第3期31-33,共3页Journal of China Prescription Drug

摘　　要：目的对康肤霜制剂的稳定性进行考察。方法采用影响因素试验、加速试验和冷处储藏试验等考察方法,对康肤霜制剂进行稳定性考察,稳定性考察指标为制剂的外观性状及主药含量变化。康肤霜中氧化锌和醋酸氯己定的含量测定采用紫外分光光度法,测定波长分别为619 nm、259 nm。结果康肤霜在60℃条件下放置10 d明显变质,40℃条件下放置10 d相对稳定;在25℃、相对湿度(RH)(90±5)%的环境下放置10 d不稳定,样品吸湿增重<5%;加速试验放置1个月,氧化锌和醋酸氯己定的含量均略有下降;冷处储藏15个月样品外观有明显变化。结论本品在高温环境下存储极易变质;40℃条件下放置10 d稳定;高湿度条件下存储霜剂的均匀度及基质性质改变,不稳定;加速试验放置1个月样品稳定;样品外观性状在冷处储藏15个月环境下不稳定。Objective To investigate the stability of Kangfu Cream.Methods The stability of Kangfu Cream was investigated by means of influence factor test,accelerated test and cold storage test.The stability of the preparation was evaluated by its appearance and main drug content.The contents of zinc oxide and chlorhexidine acetate in Kangfu Cream were determined by ultraviolet Spectrophotometer at 619 nm and 259 nm,respectively.Results The Kangfu Cream was obviously deteriorated at 60℃for 10 days,and was relatively stable at 40℃for 10 days;After 10 days of exposure to relative humidity(RH)(90±5)%at 25℃,the samples were not stable and the hygroscopicity and weight gain were less than 5%.The contents of zinc oxide and chlorhexidine acetate decreased slightly after one month of accelerated test;The appearance of the samples changed obviously after 15 months storage in cold place.Conclusion This product is easy to deteriorate in high temperature storage environment;It was stable for 10 days at 40℃;Under the condition of high humidity,the uniformity of cream and the nature of the matrix change and become unstable;The sample was stabilized by accelerated test for one month;The appearance of the sample was unstable in cold storage for 15 months.

关 键 词：醋酸氯己定 氧化锌 紫外分光光度法 稳定性 

分 类 号：TQ460.72[医药卫生—药物分析学] O657.32[化学工程—制药化工]