S. Colombo Serra , A. Fringuello Mingo , C. Incardona , A. Bergantin , E. Vurro , E. Bruno , F. Tedoldi
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引用次数: 0
摘要
导言碘化造影剂(ICM)暴露于 X 射线的情况并不少见,因为造影剂通常存放在靠近放射设备的地方。然而,文献中对 X 射线与碘化造影剂之间相互作用的研究并不多。本研究旨在调查两种常用于诊断成像的商用碘化 ICM--碘甲萘酚和碘帕米多在 X 射线照射下的化学稳定性。方法将碘帕米多和碘美醇的不同配方(碘浓度为 9 至 400 毫克碘/毫升,体积为 50 至 500 毫升)暴露在三种不同的 X 射线辐照条件下:(i) 在 CT 室中储存 1 个月(≈5 至 15 mGy);(ii) 低剂量方案(≈10 mGy);(ii) 高强度方案(≈100 mGy)。用高效液相色谱法测定未暴露和暴露溶液中的活性药物成分(API)、碘种类和副产品的浓度。此外,还检查了溶液的外观和颜色,并测量了 pH 值。结论高达 100 mGy 的 X 射线照射不会导致碘甲丙醇和碘帕米多制剂发生任何变化,也不会导致碘种类或副产品的浓度出现可检测到的增加。
Stability testing of iomeprol and iopamidol formulations subjected to X-ray radiation
Introduction
Exposure of iodinated contrast media (ICM) to X-rays is not uncommon, as contrast media are often stored in close proximity to radiological equipment. However, the interaction between X-rays and ICM is not widely investigated in literature. The present study aims to investigate the chemical stability of iomeprol and iopamidol, two commercial iodinated ICM commonly used in diagnostic imaging, under X-rays exposure.
Methods
Different formulations of iopamidol and iomeprol (iodine concentration 9 to 400 mgI/mL, volume 50–500 mL) were exposed to three different conditions of X-ray irradiation: i) 1 month storage in CT room (≈5–15 mGy); (ii) low-dose protocol (≈10 mGy); (ii) stressed protocol (≈100 mGy). Unexposed and exposed solutions were characterized by high-performance liquid chromatography in terms of concentration of active pharmaceutical ingredient (API), iodine species and by products. In addition, appearance and colour of the solutions were inspected and pH measured.
Results
API concentrations, appearance, colour and pH of the exposed formulations remained unaffected by X-rays. Measured concentrations of iodine species and by products were observed well within the acceptability criteria, i.e. values turned out to be lower than specifications limits established by the manufacturer, considering both release and shelf-life values.
Conclusions
Up to 100 mGy X-ray exposure did not induce any alteration of iomeprol and iopamidol formulation, nor a detectable increase in the concentration of iodine species or by-products.
Implications for practice
Our study strengthens the hypothesis that ICM are stable under X-rays exposure up to 100 mGy.
RadiographyRADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING-
CiteScore
4.70
自引率
34.60%
发文量
169
审稿时长
63 days
期刊介绍:
Radiography is an International, English language, peer-reviewed journal of diagnostic imaging and radiation therapy. Radiography is the official professional journal of the College of Radiographers and is published quarterly. Radiography aims to publish the highest quality material, both clinical and scientific, on all aspects of diagnostic imaging and radiation therapy and oncology.