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作 者:田甜 江燕 李纲 谭静玲 柳艳云 TIAN Tian;JIA Yan;LI Gang;TAN Jingling;LIU Yanyun(Hubei Institute for Drug Control,Wuhan 430075,China;Hubei Engineering Research Center for Drug Quality Control,Wuhan 430075,China)
机构地区:[1]湖北省药品监督检验研究院,武汉430075 [2]湖北省药品质量检测与控制工程技术研究中心,武汉430075
出 处:《中国药品标准》2023年第5期529-533,共5页Drug Standards of China
基 金:国家药典委员会药用辅料标准提高任务(2023Y020);2021年药品国家评价性抽验任务。
摘 要:目的:测定十二烷基硫酸钠的表面张力,分析表面张力随溶液浓度变化的规律以及表面张力与其他功能相关指标之间的相关性。方法:采用吊片法测定十二烷基硫酸钠的表面张力,采用《中国药典》2020年版四部十二烷基硫酸钠品种标准项下方法测定氯化钠和硫酸钠以及脂肪醇组成。结果:十二烷基硫酸钠的表面张力随浓度的升高逐渐减小,到达一定浓度后,值变化较小趋于平稳。表面张力与十二醇含量在0.05水平上呈显著的正相关性。结论:十二烷基硫酸钠作为表面活性剂应用于药物制剂时,应对表面张力这一功能性指标予以关注,以便筛选出对制剂处方适用性良好的药用辅料。Objective:To determine the surface tension of sodium lauryl sulfate,analyze the change rule of surface tension with solution concentration and the correlation between surface tension and other functional related indicators.Methods:The surface tension of sodium lauryl sulfate was determined by the suspension method,and the composition of sodium chloride,sodium sulfate and fatty alcohol was determined by the method under the standard of sodium lauryl sulfate in the Chinese Pharmacopoeia 2020 volumeⅣ.Results:The surface tension of sodium lauryl sulfate gradually decreased with the increase of concentration,and the value changed slightly and became stable after reaching certain concentration.The surface tension was significantly positively correlated with the content of dodecanol at the level of 0.05.Conclusion:When sodium lauryl sulfate is used as surfactant in pharmaceutical preparations,attention should be paid to the functional index of surface tension so as to screen out pharmaceutical excipients with good compatibility on formulation prescription.
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