丁酸氢化可的松乳膏原辅料相容性研究

Study on Compatibility of Raw Materials and Excipients of Hydrocortisone Butyrate Cream

目的:筛选丁酸氢化可的松(HB)外用乳膏制剂的辅料,以提高外用乳膏制剂的稳定性。方法:分别将HB和各种辅料按一定比例混合,并做平行对照实验,按稳定性影响因素试验方法,检查HB含量和有关物质前后的变化。结果:在光照4500 lx±500 lx、温度40℃±2℃、相对湿度65%±5%试验条件下,HB与二甲基亚砜、樟脑、平平加A-20、吐温80、枸橼酸-枸橼酸钠缓冲溶液(pH5.2)相容性较好;制剂稳定性试验表明杂质Ⅰ、杂质Ⅱ及主药HB含量无明显变化。结论:二甲基亚砜、樟脑;平平加A-20、吐温80;枸橼酸-枸橼酸钠缓冲溶液(pH5.2)可分别作为含HB的乳膏制剂的促透剂、乳化剂、稳定剂。

Objective:To study the compatibility of different excipient and hydrocortisone butyrate,for screening excipients of cream preparation containing hydrocortisone butyrate and improving the stability of cream containing hydrocortisone butyrate.Methods:According to the test method for the influence factors of stability,the hydrocortisone butyrate and different excipients were blended by a certain proportion.The changes of hydrocortisone butyrate and related excipients were measured by parallel controlled experiment.Results:Under the experimental conditions of high light(4500 lx±500 lx),high temperature(40℃±2℃)and high humidity(65%±5%),the compatibility of hydrocortisone butyrate and the related excipients dimethyl sulfoxide,camphor,Peregal A-20,Tween 80,citric acid-sodium citrate buffer solution(pH5.2)were good.Conclusion:Dimethyl sulfoxide,camphor,Peregal A-20,Tween 80,citric acid-sodium citrate buffer solution(pH5.2)can be used respectively as penetration enhancer,emulsifier and stabilizer of cream containing hydrocortisone butyrate.