目的：对囊型宫内节育器避孕材料的细胞毒性的潜在性作出评价。方法：采用研制的硅橡胶材料与高密度聚乙烯材料作为对照，根据GBT 16886.5―2003医疗器械生物学评价第5部分标准，设立空白对照组、阴性对照（高密度聚乙烯）浸提液组、阳性对照液（含6.3 %苯酚的RPMI1640完全培养液）组、100 %、50 %和25 %材料（硅橡胶）浸提液组共6个组；用RPMI 1640完全培养液培养L-929细胞，每组加入100 μL的空白对照液、阴性对照浸提液和25 %、50 % 、100 %的材料浸提液及阳性对照液，观察细胞形态和增值率。结果：空白对照组、阴性对照浸提液组、阳性对照组、100 %、50 %和25 %浓度材料浸提液组的细胞毒性级别分别为：0级、1级、4级、2级、2级、1级。100 %、50 %和 25 %材料浸提液组培养72 h后细胞增值率分别是（66.2 ± 4.3） %、（72.4 ± 6.1） %、（81.1 ± 4.2 ） %；阴性对照浸提液组、100 %、50 %、25 %材料浸提液组和阳性对照浸提液组OD（optical density）值与空白对照组比较差异有统计学意义（P <0.05）；空白对照组、100 %、50 %材料浸提液和阳性对照液组OD值与阴性对照浸提液组差异有统计学意义（P <0.05）；25 %材料浸提液OD值和与阴性对照浸提液组差异无统计学意义（P >0.05）。结论：根据GBT 16886.5―2003医疗器械生物学评价第11部分标准，所测硅橡胶材料细胞毒性评价符合要求。

Objective: To evaluate the cytotoxicity of contraceptive materials of scrotiform Intrauterine Device (IUD). Method: Make a cytotoxicity experiment with the additional liquid silicone rubber newly developed (formula: vinyl silicone oil, hydrogen silicone oil, and 1- ethynylcyclohexanol) in accordance with Part 5 of GBT16886.5-2003 Biological Evaluation of Medical Devices. 6 groups in total including blank control group (with no RPMI1640 complete culture solution of the experimental material), negative control extract solution group (high Density Polyethylene material), positive control solution group (with RPMI1640 complete solution of 6.3% phenol), 100%, 50% and 25% material extract group were set. Cultivate L-929 cell with RPMI 1640 complete culture medium ; add 100 μL blank control solution, negative extract solution and 25%, 50% and 100% material extract solutions, and observe cellular morphology under the microscope; and measure OD value with a microplate reader and observe proliferation rate of the cells. Results: Blank control group, negative control extract solution group, positive control solution group, 100% ,50%,25% material extract group’s cell cytotoxicity of experimental materials are in level 0, 1, 4, 2, 2 and 1 respectively . After 72 hours, 25% ，50% and

1973年出生，女，贵州赤水市人，硕士，主任医师，主要从事计划生育、生殖内分泌和宫内节育器研制方面的工作