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人造玻璃纤维 (MMVF) 的溶解使用USP-4:第I部分. 闭环配置测试的流体选择

Denis V Okhrimenko¹, Léa Hiéronimus², John W Hoffman³

¹ROCKWOOL A/S, Hovedgaden 584, 2640 Hedehusene, Denmark.

Toxicology letters

|February 21, 2026

概括

这项研究使用美国药典装置4开发了一个人造玻璃纤维 (MMVF) 的体外溶解试验. 该方法成功区分了纤维溶解度,显示了生物溶解性测试的前景.

科学领域:

材料科学材料科学材料科学
毒理学毒理学毒理学
分析化学分析化学

背景情况:

人造玻璃纤维 (MMVF) 需要可靠的体外溶解测试来评估安全性.
现有的方法可能无法充分区分不同纤维类型的可溶性概况.

研究的目的:

开发和验证使用美国药典装置4 (USP-4) 开发和验证MMVF的体外非细胞溶解协议.
为了在玻璃纤维和石毛纤维之间实现强大的可溶性差异化.
为了在生理 (pH 7.4) 和解体 (pH 4.5) 条件下评估合成肺液.

主要方法:

使用USP-4闭环配置进行溶解实验.
在pH7.4和pH4.5下,在多个实验室与各种MMVF类型测试了合成肺液.
研究了pH值变化和有机成分对纤维溶解的影响.

主要成果:

使用候选液体,USP-4方法成功地区分了高和低可溶性纤维.
控制pH的变化和调整液体中的有机水平对于准确的溶解测量至关重要.
在体外非细胞生物溶性测试中证明了良好的实验室间可重复性.

结论:

开发的USP-4闭环协议为体外MMVF生物溶性评估提供了一个强大的方法.
建议在pH 7.4时使用酸盐基缓冲剂,在pH 4.5时使用酸盐或PSF+酸盐基缓冲剂.
这些发现支持使用USP-4进行标准化和可靠的纤维溶解测试.

关键词:

在体外无细胞溶解.人造玻璃纤维 (MMVF) 是一种人造玻璃纤维.新的替代方法 (NAM)合成玻璃纤维 (SVF) 是一种美国药典设备4 (USP-4)模拟的肺部液体

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