伊维菌素光降解杂质的分离与鉴定  

Isolation and identification of photodegradation impurities in ivermectin

作　　者：李晓露[1] 任风芝[1] 高月麒 马志珺[1] 林旸[1] 张雪霞[1] 胡晓敏 Li Xiao-lu;Ren Feng-zhi;Gao Yue-qi;Ma Zhi-jun;Lin Yang;Zhang Xue-xia;Hu Xiao-min(New Drug Research&Development Company of NCPC,National Engineering Research Center of Microbial Drugs,Shijiazhuang 052165;North China Pharmaceutical Group Aino Co.Ltd,Shijiazhuang 052165)

机构地区：[1]华北制药集团新药研究开发有限责任公司,微生物药物国家工程研究中心,石家庄052165 [2]华北制药集团爱诺有限公司,石家庄052165

出　　处：《中国抗生素杂志》2021年第5期412-415,共4页Chinese Journal of Antibiotics

基　　金：河北省科技研发平台建设专项(No.199676154H)。

摘　　要：目的分离和鉴定伊维菌素光降解杂质,为其储存条件选择提供依据。方法伊维菌素精粉通过光降解试验得到高比例目标杂质,然后采用色谱纯化技术分离制备目标杂质化合物,再通过波谱分析鉴定杂质结构。结果伊维菌素精粉在(4500±500)Lx条件下放置120h,目标降解杂质占比大于5.0%。通过单体化合物的制备和波谱分析,确定目标杂质为8a-hydroperoxyivermectin B1a。结论建立了伊维菌素光降解杂质的制备方法,并通过杂质纯化和波谱分析,确定了杂质结构,为伊维菌素储存条件的选择提供了参考。Objective To isolate and identify the photodegradable impurities of ivermectin,and provide reference for the selection of storage conditions.Methods High proportion of target impurities was obtained by photodegradation test of ivermectin refined powder.The target impurity was isolated by chromatography purification technology,and the structure of the impurity was identified by spectral analysis.Results More than 5.0%of the target degradation impurities was obtaied in degraded sample that was placed at(4500±500)Lx for 120 hours.The target impurity compound was prepared and identified,and it was named as 8a-hydroperoxyivermectin B1a.Conclusion The method of preparing ivermectin photodegradation impurity was established.The structure of the target impurity was identified by purification and spectral analysis,which provided a reference for the selection of storage conditions of ivermectin.

关 键 词：伊维菌素 光降解杂质 制备色谱 分离纯化 结构鉴定 

分 类 号：R978.1[医药卫生—药品]