含铜宫内节育器铜丝和+铜套在模拟宫腔液中的腐蚀*☆

背景：含铜宫内节育器有较好的避孕效果是铜在宫腔内腐蚀而释放出铜离子的结果，因而铜的腐蚀行为直接关系到含铜宫内节育器能否安全、有效、长期使用。 目的：观察宫内节育器铜管与铜丝在模拟宫腔液中浸泡后的腐蚀形貌。 设计、时间及地点：体外观察实验，于2008-10/12在中国药品生物制品检定所与北京科技大学电镜室完成。 材料：实验使用天津医疗器械厂生产的健美牌宫内节育器，型号为TCu380A和TCu220C。 方法：分别将相同表面积的含铜宫内节育器铜丝及铜套浸在模拟宫腔液中，定期换液。取未浸泡前，浸泡10，30，60 d的样品，用扫描电镜观察表面形貌。 主要观察指标：样品表面形貌。 结果：未浸泡铜丝上有拉痕，腐蚀反应的产物沉积在铜丝表面，从而TCu380A开始浸泡阶段暴释效应明显；而铜套的腐蚀过程出现许多蚀坑，蚀坑刚出现时，增大铜表面积，随后腐蚀反应的产物沉积在表面，从而TCu220C的铜离子的释放速率开始时增加，后期下降。 结论：含铜宫内节育器的铜套与铜丝浸泡在模拟宫腔液中的初期，腐蚀形貌存在明显差异。铜丝表面为均一的、密集的小的蚀坑，而铜套表面为分布不规则的大的蚀坑。

Corrosion of wire and tube of copper-bearing intrauterine device in simulated uterine solution

BACKGROUND: Copper-bearing intrauterine device has a good contraception effect involving in release of copper ion in the simulated uterine solution. Therefore, the corrosion of copper directly relates to security, efficacy, and long-term application of copper-bearing intrauterine device. OBJECTIVE: To investigate the corrosion of tube and wire of copper-bearing intrauterine device in the simulated uterine solution. DESIGN, TIME AND SETTING: An in vitro observational study was performed at National Institute for the Control of Pharmaceutical and Biological Product and Electron Microscope Laboratory of Beijing University of Science and Technology from October to December 2008. MATERIALS: Copper-bearing intrauterine device (TCu380A and TCu220C) was provided by Tianjin Medical Apparatus and Instruments Factory. METHODS: Copper wire and copper tube of the same surface area were dipped in the simulated uterine solution which was changed in regularity. Surface morphology of samples was observed under scanning electron microscope before dipping, and at day 10, 30, and 60 after dipping. MAIN OUTCOME MEASURES: Surface morphology. RESULTS: Draw trace was observed on the surface of copper wire, which in some extent contributed to the burst release of copper-bearing intrauterine device (TCu380A). While in the initial immersion phase, pits appeared on the surface of copper tube and increased the copper surface area. So cupric ion release rate of copper-bearing intrauterine device (TCu220C) increased firstly and then decreased. CONCLUSION: There was significant different in surface morphology between copper tube and copper wire in the simulated uterine solution in an early phase. For example, uniformed and dense small pits were distributed on the surface of copper wire, but irregular and large pits were distributed on the surface of copper tube.