宫形不锈钢宫内节育器支架包覆硅橡胶膜的性能研究

Performance study on a stainless steel intrauterine device coated with silicone rubber

目的:宫形不锈钢宫内节育器(IUD)包覆硅橡胶膜后,可减少IUD对子宫内膜的刺激性。本文探讨硅橡胶膜对Cu^(2+)的控释性能,为新型IUD的研制提供一条良好途径。方法:以宫型不锈钢含铜IUD为支架,对包膜加成型硅橡胶在子宫腔内模拟液、生理盐水中对Cu^(2+)的释放性能进行研究,利用原子吸收光谱测定Cu^(2+)在上述介质中的日释放浓度和累积释放浓度。结果:美国DOW CORNING公司生产的加成型硅橡胶具有较高的撕裂强度、较低的硬度,作为IUD包覆膜具有良好的弹性和成型工艺性。包覆硅橡胶的宫形IUD在宫内模拟液中,Cu^(2+)的累积释放量浓度不断增加,同时,较之包覆硅橡胶膜前,Cu^(2+)释放量大为降低(P<0.05)。结论:加成型硅橡胶对Cu^(2+)具有良好的控释和缓释性,为新型IUD的研制作了很好的探索。

Objective Coating with silicone rubber of the uterine-shaped stainless steel intrauterine device （IUD） reduces endometrial irritation by the IUD.This study was conducted to assess the effect of silicone rubber coating on sustained release of Cu^2＋ from the IUD and provide evidence for the development of a novel IUD.Methods The uterine-shaped stainless steel copper-containing IUD with addition-cured silicone rubber was tested for Cu^2＋ release properties in a simulated uterine fluid and physiological saline.The daily release and cumulative release of Cu^2＋ in different media were determined using atomic absorption spectroscopy.Results The addition-cured silicone rubber （DOW CORNING Co.,USA） had a good flexibility and plasticity for use as the coating of the IUD to provide a high tear strength and a low hardness.The uterine-shaped IUD coated with silicone rubber showed an increasing cumulative release of Cu^2＋ in the simulated uterine fluid.Cu^2＋ release from the coated IUD was significantly decreased compared with that from the IUD without silicone rubber coating （P〈0.05）.Conclusion Addition-cured silicone rubber coating is capable of controlled and sustained release of Cu^2＋ and can be used for the development of a novel IUD.