• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验

大容量预填充注射器和小瓶中放射造影剂的质量评估。

Quality evaluation of radiographic contrast media in large-volume prefilled syringes and vials.

作者信息

Sendo T, Hirakawa M, Yaginuma M, Aoyama T, Oishi R

机构信息

Department of Hospital Pharmacy, Faculty of Medicine, Kyushu University, Fukuoka, Japan.

出版信息

Acad Radiol. 1998 Jun;5(6):444-7. doi: 10.1016/s1076-6332(98)80032-9.

DOI:10.1016/s1076-6332(98)80032-9
PMID:9615155
Abstract

RATIONALE AND OBJECTIVES

The authors compared the particle contaminations of radiographic contrast media packaged in large-volume prefilled syringes and vials.

MATERIALS AND METHODS

Particle counting was performed for four contrast media packaged in large-volume prefilled syringes (iohexol, ioversol, ioversol for angiography, and ioxaglate) and three contrast media packaged in vials (iohexol, ioversol, and ioxaglate). X-ray emission spectrometry was performed to characterize the individual particles. The amount of silicone oil in the syringe was quantified with infrared spectrophotometry.

RESULTS

The particle contamination in syringes containing ioversol was higher than that in syringes containing iohexol or ioxaglate. Particle contamination in the vials was relatively low, except with ioxaglate. X-ray emission spectrometry of the components of the syringe and vial showed that the source of particles was internal material released from the rubber stopper or inner surface.

CONCLUSION

The particle counts for contrast media packaged in syringes and vials varied considerably among the different contrast media and were related to the amount of silicone oil on the inner surface and rubber piston of the syringe.

摘要

原理与目的

作者比较了大容量预填充注射器和小瓶包装的放射造影剂的颗粒污染情况。

材料与方法

对四种大容量预填充注射器包装的造影剂(碘海醇、碘佛醇、血管造影用碘佛醇和碘克沙醇)和三种小瓶包装的造影剂(碘海醇、碘佛醇和碘克沙醇)进行颗粒计数。采用X射线发射光谱法对单个颗粒进行表征。用红外分光光度法定量注射器中的硅油含量。

结果

含碘佛醇的注射器中的颗粒污染高于含碘海醇或碘克沙醇的注射器。小瓶中的颗粒污染相对较低,但碘克沙醇除外。注射器和小瓶成分的X射线发射光谱显示,颗粒来源是从橡胶塞或内表面释放的内部材料。

结论

注射器和小瓶包装的造影剂的颗粒计数在不同造影剂之间差异很大,并且与注射器内表面和橡胶活塞上的硅油含量有关。

相似文献

1
Quality evaluation of radiographic contrast media in large-volume prefilled syringes and vials.大容量预填充注射器和小瓶中放射造影剂的质量评估。
Acad Radiol. 1998 Jun;5(6):444-7. doi: 10.1016/s1076-6332(98)80032-9.
2
Characterization of the initial level and migration of silicone oil lubricant in empty prefilled syringes for biologics using infrared spectroscopy.使用红外光谱法对生物制品预充式空注射器中硅油润滑剂的初始水平和迁移情况进行表征。
PDA J Pharm Sci Technol. 2014 Sep-Oct;68(5):494-503. doi: 10.5731/pdajpst.2014.00991.
3
CONTAMINATION OF ANTI-VEGF DRUGS FOR INTRAVITREAL INJECTION: How Do Repackaging and Newly Developed Syringes Affect the Amount of Silicone Oil Droplets and Protein Aggregates?抗血管内皮生长因子药物污染用于玻璃体内注射:重新包装和新开发的注射器如何影响硅油液滴和蛋白聚集体的量?
Retina. 2018 Oct;38(10):2088-2095. doi: 10.1097/IAE.0000000000001809.
4
Impact of Drug Formulation Variables on Silicone Oil Structure and Functionality of Prefilled Syringe System.药物制剂变量对预填充注射器系统硅油结构和功能的影响。
PDA J Pharm Sci Technol. 2018 Jan-Feb;72(1):50-61. doi: 10.5731/pdajpst.2017.008169. Epub 2017 Oct 12.
5
Analysis of Silicone Oil in Prefilled Syringes and Biopharmaceutical Drug Products Using High-Performance Liquid Chromatography.采用高效液相色谱法分析预充式注射器和生物制药产品中的硅油。
AAPS PharmSciTech. 2021 Feb 14;22(2):75. doi: 10.1208/s12249-021-01947-6.
6
Silicone oil droplets in repackaged anti-vascular endothelial growth factors for intravitreal injections: In search of the main source of contamination.用于玻璃体内注射的重新包装的抗血管内皮生长因子中的硅油滴:寻找主要污染源。
Eur J Ophthalmol. 2020 Jul;30(4):774-779. doi: 10.1177/1120672118823133. Epub 2019 Jan 15.
7
Occurrence of coring after needle insertion through a rubber stopper: study with prednisolone acetate.经橡胶塞行针芯插入后发生的芯针取出:醋酸泼尼松龙研究。
Eur Radiol. 2013 Feb;23(2):424-7. doi: 10.1007/s00330-012-2602-3. Epub 2012 Aug 4.
8
Evaluation of the effect of syringe surfaces on protein formulations.评价注射器表面对蛋白质配方的影响。
J Pharm Sci. 2011 Jul;100(7):2563-73. doi: 10.1002/jps.22515. Epub 2011 Feb 11.
9
Methods To Determine the Silicone Oil Layer Thickness in Sprayed-On Siliconized Syringes.测定喷涂硅化注射器中硅油层厚度的方法
PDA J Pharm Sci Technol. 2018 May-Jun;72(3):278-297. doi: 10.5731/pdajpst.2017.007997. Epub 2018 Jan 17.
10
Effect of Various Silicone Oil And Tungsten Levels on the Stability of a Monoclonal Antibody in Nine Commercially Available Prefilled Syringes.不同硅油和钨含量对九种市售预充式注射器中单克隆抗体稳定性的影响。
J Pharm Sci. 2023 Jun;112(6):1586-1594. doi: 10.1016/j.xphs.2023.03.009. Epub 2023 Mar 17.