复方阿达帕林软膏的制备与稳定性研究

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英文篇名：Development and stability test of compound adapalene ointment 作者：陶春 ; 杨慧丹 ; 黄爱文 ; 陈珍珍 ; 张倩 ; 宋洪涛 英文作者：TAO Chun;YANG Huidan;HUANG Aiwen;CHEN Zhenzhen;ZHANG Qian;SONG Hongtao;Department of Pharmacy,Fuzong Clinical Medical College of Fujian Medical University (Fuzhou General Hospital);School of Pharmacy,Fujian Medical University; 关键词：阿达帕林 ; 莫匹罗星 ; 软膏 ; 稳定性 英文关键词：adapalene;;mupirocin;;ointment;;stability 中文刊名：YXSJ 英文刊名：Journal of Pharmaceutical Practice 机构：福建医科大学福总临床医学院(福州总医院)药学科;福建医科大学药学院; 出版日期：2019-01-25 出版单位：药学实践杂志 年：2019 期：v.37 基金：福建省自然科学基金项目(2017J01822,2018J01347);; 福建医科大学启航基金项目(2017XQ1202);; 福州总医院院立课题项目(2017Q06) 语种：中文; 页：YXSJ201901011 页数：6 CN：01 ISSN：31-1685/R 分类号：50-54+72

摘要

目的制备复方阿达帕林软膏并对其稳定性进行考察和优化。方法以PEG400和PEG3350为基质,制备含阿达帕林和莫匹罗星的复方软膏。采用影响因素试验考察和优化药物的稳定性,再经加速试验和长期试验做进一步评价。结果阿达帕林原料药在高温、高湿和强光照射下均有良好的稳定性,莫匹罗星原料药的含量在高温下快速降低,在高湿和强光照射下稳定性良好。在pH≤7时,阿达帕林和莫匹罗星有明显的降解现象,而在pH=7.5时稳定性最佳,10d时的含量>95%。PEG400和PEG3350的比例为2∶1时,软膏的黏度最佳,易于涂展,且采用0.2%三乙醇胺调节pH,显著改善了阿达帕林和莫匹罗星的稳定性。加速试验和长期试验(6个月)结果显示,软膏中阿达帕林和莫匹罗星的含量保持在95%以上。结论本实验成功制备了复方阿达帕林软膏,药物稳定性良好。
        Objective To prepare,investigate and optimize the drug stability of compound adapalene ointment.Methods The ointment containing adapalene and mupirocin were prepared with PEG400 and PEG3350as matrix.Stress test was used to evaluate and optimize the stability of drugs in the ointment.The drug stability was further tested by the acceleration test and long-term test.Results The raw adapalene was stable under high temperature,high humidity and strong light irradiation.The raw mupirocin was stable under high humidity and strong light irradiation,but was highly unstable under high temperature condition.Degradation of adapalene and mupirocin was found with pH≤7.At pH 7.5,the best stability was achieved,with over95% of the drugs remaining at day 10.Favorable ointment was prepared with PEG400∶PEG3350=2∶1.The drug stability was promoted by addition of 0.2%triethanolamine significantly.In the acceleration test and long-term test,the percentages of adapalene and mupirocin were above 95%.Conclusion The compound adapalene ointment was successfully prepared and the drug stability was excellent.

引文

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