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作者:: 李永贵1; 2; 王大鹏1; 2; 马丽霞2; 王晶1; 2△; 1.山东省药学科学院山东省化学药物重点实验室，济南 250101；2.山东省药学科学院山东省医用高分子材料重点实验室，济南 250101

Author(s):: LI Yonggui1; 2; WANG Dapeng 1; 2; MA Lixia2; WANG Jing1; 2; 1.Shandong Academy of Pharmaceutical Sciences, Shandong Provincial Key Laboratory of Chemical Drug, Jinan 250101，China；2.Shandong Academy of Pharmaceutical Sciences, Shandong Provincial Key Laboratory of Biomedical Polymers，Jinan 250101

Keywords:: Disposable sterile syringes; Residual monomer ; DCPD; Gas chromatography; Detection

摘要:: 本研究建立了一次性使用无菌注射器中残留单体DCPD、TCD和MTF的气相检测方法。采用100%聚硅氧烷柱（30 m×0.32 mm×0.25 μm），柱温155℃，载气为氮气，氢火焰离子化器（FID），进样口温度240℃，检测器温度250℃，分流比5∶1，进样量1.0 μL。结果显示三种单体DCPD、TCD、MTF分离良好，在相应范围内线性关系良好，相关系数均大于0.999，平均加样回收率均在97%～102%，RSD值均小于2%。该方法专属性强、准确度高，可用于DCPD、TCD和MTF三种残留单体的检测。

Abstract:: We established a gas phase detection method for residual monomers DCPD, TCD and MTF in disposable sterile syringes; a 100% polysiloxane column (30 m×0.32 mm×0.25 um) was used with column temperature of 155℃. The carrier gas was nitrogen, the injection port temperature was 240℃, and the temperature of FID was 250℃, the split ratio was 5:1 and the sample volume was set at 1.0 μL. The results showed that the monomers DCPD, TCD and MTF were well separated. Each monomer had a good linear relationship in the appropriate concentration range, and the correlation coefficient was greater than 0.999, the average recoveries were 97%~102%, and the RSDs were less than 2%.The method has strong specificity and high accuracy and can be used in the detection of three residual monomers of DCPD, TCD and MTF.