宫内节育器铜离子体外释放及其影响因素研究

Study on the release behavior of cupric ion in copper-bearing intrauterine devices

目的：考察10种含铜宫内节育器（IUD）中Cu2＋体外释放行为，研究影响Cu2＋体外释放因素。方法：模拟人体官腔内环境，采用原子火焰吸收法测定IUD中Cu2＋的释放量，绘制释放曲线并分析影响Cu2＋释放的因素。结果：10种IUD在60d内都呈现出不同的释放特性，“暴释型”IUD（如TCu380A）释放速率最高达28μg／d，最低至4μg／d，波动较大；“稳定型”IUD（如元宫II-300）释放速率维持在1-2μg／d，基本不存在突释现象。60d后所有IUD的Cu2＋释放均趋于平稳，释放速率恒定在1-2μg／d。对同-构型的IUDCu2＋释放曲线相似，且随着载铜面积的增加Cu2＋释放速率也越大；不同构型的IUD释放曲线不同，如HCu280和元宫II-300，虽然HCu280IUD的载铜面积稍小但其释放速率远大于元宫II-300IUD。元宫I-220（含10g吲哚美辛）IUD的释放速率比元宫II-300大（P〈0．05）。结论：各IUD的Cu2＋释放差异主要体现在初期60d内，之后都呈低速稳定的释放。开放式构型的IUD比封闭式构型IUD更易释放Cu2＋；对于同一构型的IUD，铜表面积的增加或吲哚美辛的加入均会促进Cu2＋的释放。

Objective： To investigate the release behavior of cupric ion of ten copper - bearing intrauterine devices （ Cu - IU- Ds） immersed in simulated uterine fluid and its influencing factors. Methods ： The concentration of cupric ion was determined by game atomic absorption spectrometer （FAAS）. Results： The release behavior of cupric ion of ten Cu -IUDs was varied during the first 60 days after insertion, including burst release pattern such as TCu380A with a fluctuation range from 28μg/d to 4 μg/d and stable release pattern like Yuangong II-300 with a steady release rate at 1 -2μg/d. After 60 days, all the IU- Ds had a stable release rate at 1 - 2μg/d. IUDs with the same shape had similar releasing curves of cupric ion and the larger the IUDs were, the faster they released. For different shaped IUDs, their release behaviors were different. For example, HCu280 was smaller than Yuangong II -300, but its release rate of cupric ion was much higher than that of the latter. Be- sides, Yuangong I - 220 （ with 10g indomethacin） released cupric ion faster than Yuangong II - 300 （ without indomethacin）, and there was a significant difference between them. Conclusion： The cupric ion release curves are varied mainly during the first 60 days, later, they show no significant difference. IUDs with open shape could release cupric ion easier than those with closed shape. For the same shape, both the increment in area surface of copper and the addition of indomethacin would pro- mote the release of cupric ion.