制药企业生产设备清洁后膜清洗剂残留检测研究  

Residue detection of cleaning solution after cleaning of production equipment in pharmaceutical enterprises

作　　者：丁安平 和燕玲 朱磊 卢静静 覃玉梅 郑晓鹤 张辉 邵伍军 周雪飞 DING Anping;HE Yanling;ZHU Lei;LU Jingjing;QIN Yumei;ZHENG Xiaohe;ZHANG Hui;SHAO Wujun;ZHOU Xuefei(Zhejiang Hisun Pharmaceutical Co.,Ltd.,Taizhou Zhejiang 318000,China;Taizhou Vocational College of Science&Technology,Taizhou Zhejiang 318000,China)

机构地区：[1]浙江海正药业股份有限公司,浙江台州318000 [2]台州科技职业学院,浙江台州318000

出　　处：《中兽医医药杂志》2023年第4期70-73,共4页Journal of Traditional Chinese Veterinary Medicine

基　　金：浙江省公益技术应用研究资助项目(LGN22B020002);台州市科技计划项目(21nya24)。

摘　　要：本文基于现有研究成果,运用科学合理的方法,解决膜清洗剂由于化学成分种类较多及残留分析方法开发困难的问题,有效避免交叉污染风险。采用高效液相色谱建立奇疏110膜清洗剂中主要成分异丙苯磺酸钠(SC40)和十二烷基苯磺酸钠(SDBS)残留检测方法。使用Agilent Eclipse AAA C18色谱柱进行分离,以0.2 mol/L三乙胺溶液(用磷酸调节pH值至5.3)和乙腈为流动相,梯度洗脱,流速为1.0 mL/min,紫外波长为225 nm,色谱柱柱温为30℃。该方法SDBS的定量限溶液限度为0.08μg/g,检出限溶液限度为0.03μg/g;SC40的定量限溶液限度为0.06μg/g,检出限溶液限度为0.02μg/g。本方法可以快速、简便、灵敏地测定清洗液中异丙苯磺酸钠和十二烷基苯磺酸钠的含量。Basing on the existing research results,this study use scientific and reasonable method to solve the problem that the residue analysis method was difficult to develop due to the variety of chemical components of membrane cleaning solution,so as to effectively avoid the risk of cross-contamination.HPLC was used to determine the main residue sodium cumenesulfonate(SC40)and sodium dodecyl benzene sulfonate(SDBS)in cleaning liquid.The separation was carried out on an Eclipse AAA C18 column with the gradient elution using 0.2 mol/L triethylamine solution(adjusted pH to 5.3 with phosphoric acid)and acetonitrile.The UV wavelength was maintained at 225 nm.The flow rate was set at 1.0 mL/min and the column temperature was maintained 30℃.This study showed that the limit of SDBS quantification was 0.08μg/g with the detection limit of 0.03μg/g,the limit of SC40 quantification was 0.06μg/g with the detection limit of 0.02μg/g.The method is rapid,simple and sensitive for the determination of SC40 and SDBS.

关 键 词：膜清洗剂 交叉污染 异丙苯磺酸钠 十二烷基苯磺酸钠 高效液相色谱 

分 类 号：S859.1[农业科学—临床兽医学]