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医用热硫化硅橡胶安全性评价

Toxicological Studies on Medical Heat Vulcanizing Silicone Elastomer

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【作者】 卢琦华; 潘漪清; 刘桂明; 张瑞雯; 刘力敏; 孙皎; 孟爱英;

【Author】 Lu Qi-hua;Pan Yi-qing;Liu Gui-ming;Zhang Rui-wen;LiuLi-min;Sun Jiao;Meng Ai-ying Shanghai Institute of Planned Parenthood research Shanghai Second Medical University

【机构】 上海市计划生育科学研究所药理毒理室; 江西省卫生学校; 上海第二医科大学生物材料研究室; 上海第二医科大学生物材料研究室 进修教师;

【摘要】 我们对制造国产S-117型避孕宫颈帽的医用热硫化硅橡胶材料进行了急性毒性、细胞毒性、刺激性、致热原、体外溶血、过敏、肌肉内埋植等生物相容性试验,以及致畸胎、Ames试验。结果证明该材料无明显毒性作用。

【Abstract】 S-117 contraceptive cervical cap is a kind of barrier device for contraception.It ismade of silicone elastomer.In accordance with the Chinese National Standard of MedicalHeat Vulcanizing Silicone Elastomer as drafted by the Ministry of Public Health,PRC,some toxicity tests of this silicone elastomer have been carried out.These tests included:systemic toxicity of extracts in inice,intracutaneous and eye irritation of extracts in rab-bits,pyrogenicity of extracts in rabbits,in vitro hemolysis,allergic test of extracts inGuinea pigs,intramascular implantations in rabbits for 3,10,90 and 180 days,cell cul-ture cytoxicity test,teratogenic test in rats and Ames test.Results suggest that thiselastomer shows no marked toxicities in animals.

  • 【文献出处】 生殖与避孕 ,Reproduction and Contraception , 编辑部邮箱 ,1991年04期
  • 【被引频次】1
  • 【下载频次】54
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