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首页> 外文期刊>Journal of biomedical materials research. Part B, Applied biomaterials. >Improving risk assessment of color additives in medical device polymers
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Improving risk assessment of color additives in medical device polymers

机译：改善医疗器械聚合物中颜色添加剂的风险评估

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Many polymeric medical device materials contain color additives which could lead to adverse health effects. The potential health risk of color additives may be assessed by comparing the amount of color additive released over time to levels deemed to be safe based on available toxicity data. We propose a conservative model for exposure that requires only the diffusion coefficient of the additive in the polymer matrix, D, to be specified. The model is applied here using a model polymer (poly(ether-block-amide), PEBAX 2533) and color additive (quinizarin blue) system. Sorption experiments performed in an aqueous dispersion of quinizarin blue (QB) into neat PEBAX yielded a diffusivity D=4.8 x 10(-10) cm(2)s(-1), and solubility S=0.32 wt %. On the basis of these measurements, we validated the model by comparing predictions to the leaching profile of QB from a PEBAX matrix into physiologically representative media. Toxicity data are not available to estimate a safe level of exposure to QB, as a result, we used a Threshold of Toxicological Concern (TTC) value for QB of 90 mu g/adult/day. Because only 30% of the QB is released in the first day of leaching for our film thickness and calculated D, we demonstrate that a device may contain significantly more color additive than the TTC value without giving rise to a toxicological concern. The findings suggest that an initial screening-level risk assessment of color additives and other potentially toxic compounds found in device polymers can be improved. (c) 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 310-319, 2018.
机译：许多聚合物医疗器材含有颜色添加剂，可能导致健康的不利影响。可以通过比较随着时间的推移随着时间的推移释放的彩色添加剂量来评估颜色添加剂的潜在健康风险，这是基于可用毒性数据被认为是安全的水平。我们提出了一种保守模型，用于暴露，该模型仅需要在聚合物基质，D中的添加剂的扩散系数。这里使用模型聚合物（聚（醚嵌段），PeBax 2533）和颜色添加剂（喹硫嗪蓝）系统来应用该模型。在喹硫嗪蓝（QB）的水分散中进行的吸附实验进入纯Peax的扩散率D = 4.8×10（-10）cm（2）s（-1），溶解度S = 0.32wt％。在这些测量的基础上，我们通过将QB的浸出轮廓与PEBAX矩阵与生理学代表性介质进行比较来验证模型。结果，毒性数据无法估计QB的安全水平，因此我们使用了毒理学关注的阈值（TTC）值为90μg/成人/日的QB。因为只有30％的QB在浸出的薄膜厚度和计算的D浸出的第一天释放，所以我们证明了装置可以含有比TTC值更明显的颜色添加剂，而不会产生毒理学关注。结果表明，可以改善初始筛选水平风险评估和在装置聚合物中发现的其他潜在有毒化合物。 （c）2017 Wiley期刊，Inc。J生物保解率B：Appl Biomater，106B：310-319,2018。

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