HPLC法同时测定医用橡胶中4种添加剂  

Simultaneous Determination of Four Additives in Medical Rubber Materials by HPLC

作　　者：翟小语 吴莹[1] 张毅兰[1] ZHAI Xiaoyu;WU Ying;ZHANG Yilan(CFDA Research and Inspection Center of Pharmaceutical Packaging Materials,Shanghai Institute of Pharmaceutical Industry,China State Institute of Pharmaceutical Industry,Shanghai 201203)

机构地区：[1]中国医药工业研究总院,上海医药工业研究院,国家食品药品监督管理总局药品包装材料科研检验中心,上海201203

出　　处：《中国医药工业杂志》2020年第9期1202-1207,共6页Chinese Journal of Pharmaceuticals

摘　　要：建立了 HPLC 法测定医用橡胶中 4 种添加剂 2-巯基苯并噻唑、2-巯基苯并咪唑、苯并噻唑、2-甲硫基苯并噻唑,考察了影响材料提取的不同因素,并研究了4种添加剂在不同模拟介质中的提取量。结果显示,4种添加剂分别在0.03~3.41 μg/ml、0.01~1.01 μg/ml、0.36~36.20 μg/ml、0.03~3.44 μg/ml内线性关系良好。材料提取回收率为119.4%~96.7%,RSD小于6.77%,在pH 3.0盐酸溶液、pH 6.0纯化水、pH 11.0氢氧化钠溶液、15%乙醇这4个模拟介质中的回收率为81.9%~114.7%,RSD小于3.77%,该方法专属性好、灵敏度高,可用于医用橡胶制品中4种添加剂的测定。An HPLC method was established for the determination of 2-mercaptobenzothiazole,2-mercapto-benzimidazole,benzothiazole,2-methylthiobenzothiazole in medical rubber.The different factors influencing the extraction efficiency of the materials were investigated,and the extraction amount of the four additives in different simulated media was studied.The results showed that it was linear for the four additives in the range of 0.03-3.41 μg/ml,0.01-1.01 μg/ml,0.36-36.20 μg/ml and 0.03-3.44 μg/ml.The recoveries in the extraction of materials ranged from 119.4% to 96.7%,and the RSD was less than 6.77%.The recoveries ranged from 81.9% to 114.7% in the simulated media including pH 3.0 hydrochloric acid solution,pH 6.0 purified water,pH 11.0 sodium hydroxide solution,and 15%ethanol,with the RSD was less than 3.77%.The method is specific and sensitive,which can be applied successfully to the determination of the four additives in medical rubber products.

关 键 词：医用胶塞 高效液相色谱法 橡胶添加剂 包材相容性 

分 类 号：O657.72[理学—分析化学] TQ336.6[理学—化学]