同种异体骨产品中有机溶剂残留分析

doi:10.3969/j.issn.1004-616x.2016.04.014

癌变·畸变·突变 ›› 2016, Vol. 28 ›› Issue (4): 314-316,331.doi: 10.3969/j.issn.1004-616x.2016.04.014

同种异体骨产品中有机溶剂残留分析

付步芳¹, 王丽²

1. 中国食品药品检定研究院, 北京 100050;
2. 河北省医疗器械与药品包装材料检验研究院, 河北石家庄 050061

收稿日期:2016-01-08 修回日期:2016-06-28 出版日期:2016-07-31 发布日期:2016-07-31
作者简介:付步芳,E-mail:fbf377@163.com;王丽,E-mail:wangli_0219@163.com

Determination of residual organic solvents in allogeneic bones

FU Bufang¹, WANG Li²

1. National Institutes for Food and Drug Control, Beijing 100050;
2. Hebei Province Testing Institute for Medical Devices and Pharmaceutical Packing, Shijiazhuang 050061, Hebei, China

Received:2016-01-08 Revised:2016-06-28 Online:2016-07-31 Published:2016-07-31

摘要/Abstract

摘要： 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。

关键词: 气相色谱-质谱联用, 同种异体骨, 有机溶剂, 残留

Abstract: OBJECTIVE: To establish a GC-MS method for determination of residual organic solvents in allogeneic bones. METHODS: A SCAN mode of GC-MS was used to determine the presence of residual organic solvents in allogeneic bones and a SIM mode was used to quantify ten kinds of organic solvent residues. RESULTS: Several organic solvents were observed, including methanol, ethanol and dichloromethane, etc. Residual benzene was found in many samples. The total residual organic solvents in allogeneic bones were up to 167.45 μg/g. The linear R of the quantitative method was above 0.99. The average recovery rate was between 90.5%-113.8% and the precision was between 1.00%-3.19%. CONCLUSION: Our data show that the established GC-MS method was accurate and suitable for the determination of residual organic solvents in allogeneic bones.

Key words: gas chromatography-mass spectrometry, allogeneic bone, organic solvent, residual

中图分类号:

R318.0

付步芳, 王丽. 同种异体骨产品中有机溶剂残留分析[J]. 癌变·畸变·突变, 2016, 28(4): 314-316,331.

FU Bufang, WANG Li. Determination of residual organic solvents in allogeneic bones [J]. Carcinogenesis, Teratogenesis & Mutagenesis, 2016, 28(4): 314-316,331.

[1]	付步芳, 王春仁. 医疗器械检测用DEHP标准物质的研究[J]. 癌变·畸变·突变, 2017, 29(4): 316-321,324.
[2]	周培一(综述);李维佳(审校). 黑色素瘤特异性抗原基因与血液恶性肿瘤[J]. , 2005, 17(4): 254-256.

同种异体骨产品中有机溶剂残留分析

Determination of residual organic solvents in allogeneic bones

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