盐酸特比萘芬与硬脂酸的原辅料相容性研究  

Compatibility of raw and excipient between terbinafine hydrochloride and stearic acid

作　　者：周颖 谢莹莹 郑金凤 刘雁鸣 ZHOU Ying;XIE Yingying;ZHENG Jinfeng;LIU Yanming(Hunan Institute for Drug Control,NMPA Key Laboratory for Pharmaceutical Excipients Engineering Technology Research,Changsha 410001,China)

机构地区：[1]湖南省药品检验检测研究院,国家药品监督管理局药用辅料工程技术研究重点实验室,长沙410001

出　　处：《中国药品标准》2022年第5期461-466,共6页Drug Standards of China

基　　金：湖南省自然科学基金-科药联合基金项目(No.2021JJ80042)。

摘　　要：目的:考察盐酸特比萘芬与硬脂酸的化学相容性。方法:将原料药盐酸特比萘芬与辅料硬脂酸混合后,通过稳定性影响因素实验,采用高效液相色谱法,考察有关物质的变化。结果:在高温60℃和照度4500lx条件下,盐酸特比萘芬与硬脂酸配伍后,特比萘芬杂质A、特比萘芬杂质B及杂质总量均有不同程度的增长,并新增1个未知杂质,且不同型号的硬脂酸对盐酸特比萘芬有关物质的影响有差异。结论:盐酸特比萘芬和硬脂酸在高温和光照条件下存在相容性风险,提示生产企业应优化处方,选择质量更优的辅料,提升产品安全性和质量。Objective:To investigate the chemical compatibility of terbinafine hydrochloride with stearic acid.Methods:After mixing the bulk drug terbinafine hydrochloride with the excipient stearic acid,the changes of related substances were investigated by using high performance liquid chromatography through the stability influencing factor experiment.Results:Under the conditions of high temperature 60℃and light 4500 lx,after terbinafine hydrochloride is mixed with stearic acid,terbinafine impurity A,terbinafine impurity B and the total amount of impurities all increase to varying degrees,and an increase of one unknown impurity,and different types of stearic acid have different effects on related substances of terbinafine hydrochloride.Conclusion:There is a risk of compatibility between terbinafine hydrochloride and stearic acid under high temperature and light conditions,suggesting that manufacturers should optimize the prescription and choose excipients with better quality to improve product safety and quality.

关 键 词：盐酸特比萘芬 硬脂酸 药用辅料 相容性 高效液相色谱法 

分 类 号：R921.2[医药卫生—药学]