角膜接触镜透氧系数参考材料的研究

Reference materials for calibrating oxygen permeability in contact lenses

目的 给出一套适合用于校准极谱法测量接触镜透氧系数的参考材料.方法 对照研究.通过库伦法测量硬性接触镜材料透氧系数值,并通过批材料透氧系数离散性分析,判定所选材料是否可作为参考材料.结果 Boston的ES、EO、XO和XO24种硬性接触镜材料,当选择同一生产批时,透氧系数的一致性较符合要求,在置信水平95％状况下用2倍标准差标示时,分别为2.10％、0.64％、1.48％和3.16％,符合GB/T11417.7-2012《眼科光学接触镜第7部分：理化性能试验方法》中关于透氧系数参考材料不超过±5％的要求,6个以上的样品的透氧系数测试值的平均值可作为参考材料的名义值.结论 Boston的4种硬性接触镜材料基本能满足目前市场上软性接触镜材料透氧系数的测试要求.

Objective To find a series of reference materials that can be used to calibrate the oxygen permeability （Dk） of contact lenses using polarographic analysis.Methods A control study was performed on two different production samples to create a reference for oxygen permeability coefficients.The Dk of a rigid contact lens material was first measured by a coulometric method, then selections from samples of material were analyzed for Dk values.On the basis of the results, the selected samples were verified for use as reference material.Results For the four Boston rigid contact lens materials, the consistency of oxygen permeability met the requirements when the same production sample was chosen.The Dks, expressed as 2 times the standard deviation at a 95% confidence level, were 2.10%, 0.64%, 1.48%, and 3.16%, respectively, which conformed to the requirement of GB/T11417.7-2012 《Ophthalmic optics.Contact lenses.Part 7： Physicochemical properties test methods》.That is, the Dk reference for the material shall be known within the range of ±5%.Therefore, the average values of the oxygen permeabilities obtained from more than 6 samples can be regarded as the nominal value for a reference material.Conclusion The four Boston rigid contact lens materials （ES, EO, XO and XO2） basically meet the test requirements of oxygen permeability for the soft contact lens material available on the market.