对经过X射线辐射的IOMEPROL和IOPAMIDOL配方进行稳定性测试
S Colombo Serra1, A Fringuello Mingo1, C Incardona1
1Centro Ricerche Bracco (Bracco Imaging SpA), Via Ribes 5 Colleretto Giacosa, TO, Italy.
Radiography (London, England : 1995)
|May 21, 2024
概括
离子对比剂 (ICM) 像iomeprol和iopamidol在暴露于X射线时保持化学稳定,高达100mGy. 这一发现证实了这些对比剂在放射设备附近储存和使用的安全性.
科学领域:
- 辐射科学 辐射科学
- 制药化学 制药化学 制药化学
背景情况:
- 化对比介质 (ICM) 经常用于诊断成像.
- 存储ICM在放射学设备附近引发了关于潜在的X射线暴露的问题.
- 关于ICM在X射线照射下化学稳定性的文献有限.
研究的目的:
- 在X射线照射下研究iomeprol和iopamidol的化学稳定性.
- 为了确定X射线照射是否会影响活性药物成分 (API) 度或导致降解产品.
主要方法:
- 约梅普罗尔和约帕米多尔的配方暴露于大约5-15mGy,10mGy和100mGy的X射线剂量.
- 使用高性能液态色谱 (HPLC) 来分析API度,物种和副产品.
- 还进行了外观和颜色的视觉检查,以及pH值测量.
主要成果:
- 暴露在高达100mGy的X射线中并没有改变iomeprol和iopamidol的API度.
- 没有发现物种或副产品的显著增加,所有值都符合制造商规格.
- ICM配方的外观,颜色和pH值在暴露后保持不变.
结论:
- 梅和胺醇在暴露于高达100mGy的X射线时表现出强大的化学稳定性.
- 这项研究支持了ICM在临床环境中遇到的典型X射线暴露条件下是稳定的假设.
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