非诺贝特酸胆碱缓释胶囊生产设备的UV法清洁验证  

Validation of UV Cleaning of Manufacturing Equipment of Choline Fenofibrate Sustained-Release Capsules

作　　者：朱家乐 姜庆伟 金学军[1] ZHU Jiale;JIANG Qingwei;JIN Xuejun(College of Integration Science,Yanbian University,Yanji,Jilin Province,133002 China;Jilin Tianheng Pharmaceutical Co.,Ltd.,Meihekou,Jilin Province,135000 China)

机构地区：[1]延边大学融合学院,吉林延吉133002 [2]吉林天衡药业有限公司,吉林梅河口135000

出　　处：《科技资讯》2023年第7期64-68,共5页Science & Technology Information

摘　　要：为验证清洁操作完成后生产设备表面非诺贝特酸的残留量是否低于安全指标,建立了紫外可见分光光度法测定擦拭棉签的提取溶液中非诺贝特酸的含量。使用286 nm检测波长,1 cm吸收池,50%甲醇的溶剂。非诺贝特酸在0.95~14.25μg/mL浓度范围内线性关系良好。316不锈钢板、有机玻璃和硅胶的取样回收率分别为82.2%、75.8%、76.9%,RSD分别为9.47%、4.41%、4.06%。方法回收率为101.5%,RSD为1.05%。该UV法可用于生产设备上非诺贝特酸胆碱缓释胶囊残留物的清洁控制分析。In order to verify whether the residue of fenofibrate acid on the surface of manufacturing equipment is lower than the safety index after the cleaning operation is completed,Ultraviolet-visible(UV)spectrophotometry is established to determine the content of fenofibrate acid in swab extraction solution.A solvent with 286 nm detection wavelength,1 cm absorption cell and 50%methanol is used.Fenofibric acid shows a good linearity in the concentration range of 0.95~14.25μg/mL.The extraction recovery of 316 stainless steel plate,plexiglass and silica gel is 82.2%,75.8%and 76.9%,and RSD is 9.47%,4.41%and 4.06%,respectively.The recovery of the method is 101.5%and RSD is 1.05%.This UV method can be used for the analysis of cleaning control for the residue of Choline Fenofibrate Sustained-release Capsules on manufacturing equipment.

关 键 词：非诺贝特酸 清洁验证 紫外可见分光光度法 残留物 

分 类 号：R917[医药卫生—药物分析学]