β-TCP/HA双相骨修复材料的Ames试验研究  

Study for Ames test of β-TCP/HA Bone repair material

作　　者：陶剑[1] 袁博[1] 姜华[1] 

机构地区：[1]国家食品药品监督管理局天津医疗器械质量监督检验中心,天津300384

出　　处：《生物骨科材料与临床研究》2013年第5期1-4,共4页Orthopaedic Biomechanics Materials and Clinical Study

摘　　要：目的通过鼠伤寒沙门氏菌回复突变试验(Ames试验)探讨组分比例分别为3∶7和7∶3的磷酸三钙/羟基磷灰石(-TCP/HA)双相骨修复材料的遗传毒性特征,以评价该材料的潜在致突变性。方法采用生理盐水(SC)和二甲基亚砜(DMSO)两种介质对试验样品浸提,采用平板掺入法进行试验,计数TA97、TA98、TA100和TA102菌株在活化和非活化条件下的回变菌落数,以检测其致突变比值。结果阴性对照和阳性对照结果成立。两种比例的材料采用SC或DMSO浸提,浸提液均未引起试验菌株回变菌落数超过阴性对照的2倍,即致突变比值MR均<2。结论在本实验条件下,-TCP/HA样品SC浸提原液及DMSO浸提原液对标准试验菌株均无诱变性。Objective To evaluate the potential mutagenicity of β-TCP/HA bone repair material （3 ： 7, 7 ： 3） with Ames test. Methods Sodium Chloride solution and DMSO were used as extraction vehicle. The standard plate incorporation assay was taken. 4 standard tester strains ofTA97, TA98, TA100 and TA102 were used to detect the mutagenicity with or without S9 homogenate, and the mutagens rates （MR） of the strains were calculated. Results The experiment was valid because of the validity of negative control and positive control in the test. The mean number ofrevertants for the original extract liquid of SC and DMSO was not 2 times more than negative control, that is the MR 〈 2. Conclusion Under the conditions of this assay, the original extract liquid of SC and DMSO for 3 ： 7 and 7 ： 3 samples were considered to be nonmutagenic to the four tester strains.

关 键 词：β磷酸三钙 羟基磷灰石 AMES试验 生理盐水 二甲基亚砜 

分 类 号：R318.08[医药卫生—生物医学工程]