同种异体骨产品中有机溶剂残留分析

Determination of residual organic solvents in allogeneic bones

目的：采用气相色谱-质谱联用法（GC-MS）分析同种异体骨产品中有机溶剂残留的情况,最终建立GC-MS法定性和定量测定同种异体骨产品中溶剂残留量的方法。方法：采用GC-MS扫描（SCAN）模式对同种异体骨产品进行有机溶剂残留的定性分析,并采用GC-MS选择离子（SIM）模式对其中的10种残留溶剂进行了定量分析。结果：被测对象中检出多种有机溶剂残留,如甲醇、乙醇、二氯甲烷等,多份样品中检出了苯残留,溶剂残留总量最多达167.45μg/g。此方法对10种溶剂定量分析的线性相关系数均在0.99以上,平均加样回收率在90.5%~113.8%,相对标准偏差（RSD）在1.00%~3.19%。结论：所建立的检测方法准确、简便、快速,可用于同种异体骨产品中有机溶剂残留的检测与质量控制。

OBJECTIVE：To establish a GC-MS method for determination of residual organic solvents inallogeneic bones. METHODS：A SCAN mode of GC-MS was used to determine the presence of residual organic solventsin allogeneic bones and a SIM mode was used to quantify ten kinds of organic solvent residues. RESULTS：Severalorganic solvents were observed,including methanol,ethanol and dichloromethane,etc. Residual benzene was found inmany samples. The total residual organic solvents in allogeneic bones were up to 167.45 μg/g. The linear R of thequantitative method was above 0.99. The average recovery rate was between 90.5%-113.8% and the precision was between1.00%-3.19%. CONCLUSION：Our data show that the established GC-MS method was accurate and suitable for thedetermination of residual organic solvents in allogeneic bones.