聚羟基烷酸酯可吸收骨钉和骨板细菌内毒素检查方法的研究
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摘要
目的:建立聚羟基烷酸酯可吸收骨钉、骨板细菌内毒素检查方法。方法:通过不同方法制备供试品浸提液,按《中国药典》2010年版(二部)细菌内毒素检查法进行试验。结果:聚羟基烷酸酯可吸收骨钉、骨板在0.2 g·m L~(-1)浓度37±1℃温度下浸提1 h对细菌内毒素检查无干扰。结论:采用细菌内毒素检查法检测聚羟基烷酸酯可吸收骨钉、骨板的细菌内毒素是可行的。
Objective: To establish bacterial endotoxin test for polyhydroxyalkanoates absorbable bone screws and bone plates. Methods: The samples were prepared by different methods and measured according to Ch P. 2010 VolumeⅡ. Results: There was no influence when the polyhydroxyalkanoates absorbable bone screws and bone plates were extracted with 1h at the concentration of 0.2 g˙m L-1 and in the temperature of 37±1℃ for bacterial endotoxin test. Conclusion: It is feasible to detect the polyhydroxyalkanoates absorbable bone screws and bone plates by the method of bacterial endotoxin test.
Objective: To establish bacterial endotoxin test for polyhydroxyalkanoates absorbable bone screws and bone plates. Methods: The samples were prepared by different methods and measured according to Ch P. 2010 VolumeⅡ. Results: There was no influence when the polyhydroxyalkanoates absorbable bone screws and bone plates were extracted with 1h at the concentration of 0.2 g˙m L-1 and in the temperature of 37±1℃ for bacterial endotoxin test. Conclusion: It is feasible to detect the polyhydroxyalkanoates absorbable bone screws and bone plates by the method of bacterial endotoxin test.
引文
[1]蔡彤,张国来,李波,等.84种注射用药品细菌内毒素检查法的方法学研究[J].中国药学杂志,2010,(02):150-155.
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[4]GB/T16886.12-2005/ISO10993-12:2002医疗器械生物学评价(第12部分):样品制备与参照样品[S].2005.
[5]陈丹丹,王春仁,段晓杰,等.浸提温度对细菌内毒素影响的初步研究[J].中国医疗器械信息,2011,(08):29-30.
[6]陈丹丹,黄清泉.浸提时间对医疗器械细菌内毒素检测影响的初步研究[J].中国药事,2014,(02):172-173+184.
[2]中国药典:二部[S].2010:附录XIE 99-101.
[3]中国药品检验标准操作规范[S].2010.
[4]GB/T16886.12-2005/ISO10993-12:2002医疗器械生物学评价(第12部分):样品制备与参照样品[S].2005.
[5]陈丹丹,王春仁,段晓杰,等.浸提温度对细菌内毒素影响的初步研究[J].中国医疗器械信息,2011,(08):29-30.
[6]陈丹丹,黄清泉.浸提时间对医疗器械细菌内毒素检测影响的初步研究[J].中国药事,2014,(02):172-173+184.