医用脱脂棉及纱布中化学合成纤维的快速检测法
|
摘要
目的:建立铜氨溶液法对医用脱脂棉及纱布进行显微镜观测,以对非法添加的化学合成纤维进行快速鉴别和定性分析。方法:对湖南省医疗器械监督抽检样品中的30批医用脱脂棉和30批纱布采用铜氨溶液法观察纤维溶解的情况,取铜氨溶液法中不溶性纤维进行显微镜观察,并与标准品进行比较,确定不溶性纤维的种类。结果:检测的医用脱脂棉及纱布中,有30%的医用脱脂棉发现少量孤立外来纤维,有40%的医用纱布掺杂了化学合成纤维,其掺杂量均>10%。经过显微镜观测以及与标准品比较,确定医用脱脂棉和纱布中化学合成纤维大多数为涤纶纤维。结论:建立的铜氨溶液方法操作方便、快速、直观且准确,可作为医用脱脂棉和纱布中非法加入化学合成纤维的快速检测方法,为医用脱脂棉及纱布的监管提供技术支撑。
Objective: To establish cuprammonia method to implement microscope observation for medical degreasing cotton and gauze so as to quickly identify and qualitatively analyze chemical synthetic fibers illegally were added. Methods: The situations of fiber solution of 30 batches of medical degreasing cotton and 30 batches of gauze of the samples in supervision and casual inspection of medical device of Hunan province were observed by using cuprammonia method. And the insoluble fibers of cuprammonia method were selected to implement microexamination, and the results were compared with standard so as to determine the kinds of insoluble fibers. Results: In these tested medical degreasing cotton and gauze, 30% of medical degreasing cotton existed a few isolated and foreign fibers, and 40% of medical gauze were mingled with chemical synthetic fibers, and the mingled amount exceeding 10%. Through observation of microscope and the comparison with standards, the results determined that the most of chemical synthetic fibers of medical degreasing cotton and gauze were polyester fiber. Conclusion: The established cuprammonia method is convenient, quick, direct and accurate, and it can be used as a quick detection method for the illegal addition of chemical synthetic fibers in medical degreasing cotton and gauze, and it can provide technical support for supervision and management of medical degreasing cotton and gauze.
Objective: To establish cuprammonia method to implement microscope observation for medical degreasing cotton and gauze so as to quickly identify and qualitatively analyze chemical synthetic fibers illegally were added. Methods: The situations of fiber solution of 30 batches of medical degreasing cotton and 30 batches of gauze of the samples in supervision and casual inspection of medical device of Hunan province were observed by using cuprammonia method. And the insoluble fibers of cuprammonia method were selected to implement microexamination, and the results were compared with standard so as to determine the kinds of insoluble fibers. Results: In these tested medical degreasing cotton and gauze, 30% of medical degreasing cotton existed a few isolated and foreign fibers, and 40% of medical gauze were mingled with chemical synthetic fibers, and the mingled amount exceeding 10%. Through observation of microscope and the comparison with standards, the results determined that the most of chemical synthetic fibers of medical degreasing cotton and gauze were polyester fiber. Conclusion: The established cuprammonia method is convenient, quick, direct and accurate, and it can be used as a quick detection method for the illegal addition of chemical synthetic fibers in medical degreasing cotton and gauze, and it can provide technical support for supervision and management of medical degreasing cotton and gauze.
引文
[1]建国.欧美医用敷料市场的演进[N].中国医药报,2010-12-28(B08).
[2]姜德龙,迟安政,张启华.医用脱脂棉存在的问题及加强质量控制和监督的建议[J].法规与监管,2005,29(5):364-365.
[3]国家食品药品监督管理局.YY 0331-2006脱脂棉纱布、脱脂棉粘胶混纺纱布的性能要求和试验方法[S].国家食品药品监督管理局2006.
[4]国家食品药品监督管理局.医用脱脂棉:YY/T0330-2015[S].中国标准出版社,2015-03-02.
[5]胡松月.浅析红外光谱法鉴别纤维成分[J].天津纺织科技,2010(1):39-40.
[6]王华栋,冯晓明,汤晓阳.铜氨溶液溶解法快速分离测定生物医学工程材料医用纱布中纤维素与化学合成高分子纤维[J].药物分析杂志,2015(3):467-472.
[7]沈新元.化学纤维鉴别与检验[M].北京:中国纺织出版社,2013.
[8]国家发展和改革委员会.纺织纤维鉴别试验方法第4部分:溶解法:FZ/T01057.4-2007[S].国家发展和改革委员会,2007-05-29.
[9]张建祥,耿彩华,孟祥英.铜氨溶液法测定棉纤维聚合度[J].染整技术,2006(8):42-44.
[10]国家发展和改革委员会.纺织纤维鉴别试验方法第3部分:显微镜法:FZ/T01057.3-2007[S].国家发展和改革委员会,2007-05-29.
[2]姜德龙,迟安政,张启华.医用脱脂棉存在的问题及加强质量控制和监督的建议[J].法规与监管,2005,29(5):364-365.
[3]国家食品药品监督管理局.YY 0331-2006脱脂棉纱布、脱脂棉粘胶混纺纱布的性能要求和试验方法[S].国家食品药品监督管理局2006.
[4]国家食品药品监督管理局.医用脱脂棉:YY/T0330-2015[S].中国标准出版社,2015-03-02.
[5]胡松月.浅析红外光谱法鉴别纤维成分[J].天津纺织科技,2010(1):39-40.
[6]王华栋,冯晓明,汤晓阳.铜氨溶液溶解法快速分离测定生物医学工程材料医用纱布中纤维素与化学合成高分子纤维[J].药物分析杂志,2015(3):467-472.
[7]沈新元.化学纤维鉴别与检验[M].北京:中国纺织出版社,2013.
[8]国家发展和改革委员会.纺织纤维鉴别试验方法第4部分:溶解法:FZ/T01057.4-2007[S].国家发展和改革委员会,2007-05-29.
[9]张建祥,耿彩华,孟祥英.铜氨溶液法测定棉纤维聚合度[J].染整技术,2006(8):42-44.
[10]国家发展和改革委员会.纺织纤维鉴别试验方法第3部分:显微镜法:FZ/T01057.3-2007[S].国家发展和改革委员会,2007-05-29.