通过鼠伤寒沙门氏菌回复突变试验(Ames试验)对TLE及TLM 2种β型医用钛合金的致突变作用进行生物学评价,试验分别设计5个剂量组、自然回变对照组、溶剂对照组以及阳性对照组,采用平板掺入法在加与不加S9混合液的条件下完成.统计学分析结果显示:2种β型医用钛合金每剂量组各菌株回变菌落数均与自然回变菌落数接近,未超过其2倍,而阳性对照组超过自然回变菌落数的2倍以上.说明TLE,TLM在检测剂量(0.16μl/皿~100 μl/皿)范围内反应结果为阴性,即不具有点突变诱变性.
参考文献
[1] | 吕宇鹏,朱瑞富,马泉生,李士同,李木森,雷廷权.医用钛及钛合金种植体材料的研究进展[J].中国口腔种植学杂志,2000(01):43-49. |
[2] | Kathy Wang .[J].Materials Science and Engineering,1996,A213:134. |
[3] | Daisuke Kuroda et al.[J].Materials Science and Engineering,1998,A243:244. |
[4] | Mitsuo Niinomi .[J].Materials Science and Engineering,1998,A243:231. |
[5] | GB/T 16886.3-1997.GB/T 16886.3-1997.Biological Evaluation of Medical Devices-Part 3:Tests for Genotoxocity,Carcinogenicity and Reproductive Toxicity[S].,1997. |
[6] | 郝和平.医疗器械生物学评价实施指南[M].北京:中国标准出版社,2000:16. |
[7] | Ames B N et al.[J].Mutation Research,1975,31:347. |
[8] | ANSI/ADA No41 a.American Dental Association[S].,1982. |
[9] | 孙皎 et al.[J].生物医学工程学杂志,1994,11(01):91. |
[10] | GB/T 16886.12-2000.GB/T 16886.12-2000.Biological Evaluation of Medical Devices-Part 12:Sample Preparation and Reference Materials[S].,2000. |
[11] | GB/T 16886.5-1997.GB/T 16886.5-1997.Biological Evaluation of Medical Devices-Part 5:Tests for Cytotoxicity:In Vitro Methods[S].,1997. |
上一张
下一张
上一张
下一张
计量
- 下载量()
- 访问量()
文章评分
- 您的评分:
-
10%
-
20%
-
30%
-
40%
-
50%