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: |
|
| 摘要点击次数: |
| 全文下载次数: |
| 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. |
|
查看全文
查看/发表评论 下载PDF阅读器 |
| 关闭 |
|
|
|
渝公网安备 50010702501716号