文章摘要
兰婉玲,蒲小聪,游延军,任锟,冯霞兰,成婕.药用复合硬片中甲苯二异氰酸酯单体残留检测[J].包装工程,2018,39(1):53-57.
LAN Wan-ling,PU Xiao-cong,YOU Yan-jun,REN Kun,FENG Xia-lan,CHENG Jie.2, 4-TDI Monomer Residue Detection of Drug Composite Sheet[J].Packaging Engineering,2018,39(1):53-57.
药用复合硬片中甲苯二异氰酸酯单体残留检测
2, 4-TDI Monomer Residue Detection of Drug Composite Sheet
投稿时间:2017-06-06  修订日期:2018-01-10
DOI:
中文关键词: 甲苯二异氰酸酯单体  1, 2-吡啶哌嗪  高效液相色谱法  药品包装材料  粘合剂
英文关键词: 2, 4-TDI monomer  1, 2-pyridine-piperazine  high performance liquid chromatography (HPLC)  drug packaging material  adhesive
基金项目:
作者单位
兰婉玲 四川省食品药品检验检测院成都 611731 
蒲小聪 1.四川省食品药品检验检测院成都 6117312.四川大学成都 610064 
游延军 四川省食品药品检验检测院成都 611731 
任锟 四川省食品药品检验检测院成都 611731 
冯霞兰 四川省食品药品检验检测院成都 611731 
成婕 四川省食品药品检验检测院成都 611731 
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中文摘要:
      目的 检测药品包装材料使用的粘合剂中甲苯二异氰酸酯(2, 4-TDI)单体的残留量。方法 用乙腈提取样品后,与衍生剂1, 2-吡啶哌嗪溶液进行衍生化反应,然后采用反相高效液相色谱法测定衍生物,从而计算2, 4-TDI单体残留量,并进行方法学考察。结果 衍生物的线性范围为0~1.2 μg/mL(线性相关系数R=0.9998, 线性拟合点数n=7);精密度的相对标准偏差为1.52%;24 h内稳定性的相对标准偏差为2.51%;回收率平均值为102.63%,回收率的相对标准偏差为1.79%。结论 建立的方法可靠、结果准确、稳定性好、专属性强,能够快速测定衍生物的含量,从而计算2, 4-TDI单体的残留量,为药品包装材料所使用的粘合剂中2, 4-TDI单体残留量的检测提供有力支持。
英文摘要:
      The work aims to test the 2, 4-TDI monomer residue of the adhesive used in the drug packaging materials. The sample was extracted with acetonitrile and derivatived with 1, 2-pyridyl piperazine. Then, the derived product was tested with RP-HPLC, thus calculating the 2, 4-TDI monomer residue and investigating the methodology. The linear range of derivative was 0~1.2 μg/mL (linearly dependent coefficient R=0.9998, and number of linear fitting points n=7). The relative standard deviation (RSD) of precision was 1.52%. RSD of stability in 24 h was 2.51%. The mean recovery was 102.63% and the RSD of recovery was 1.79%. The method established is reliable, accurate, stable and specific, and can be used to test the content of derived product rapidly, thus calculating 2, 4-TDI monomer residue, and providing powerful support for the test of 2, 4-TDI monomer residue in the adhesive used by the drug packaging materials.
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