多巴胺转运蛋白显像剂99Tcm -TRODAT-1药盒及注射液的质量控制

摘要

Objective To study the quality control methods for 99Tcm-TRODAT-1 kit and injection.Methods The appearance,pH,contents of the bases,the labeling yield,asepsis and bacterial endotoxins of 99Tcm-TRODAT-1 kits from three different batches were examined.The kit stability was estimated under different conditions.The transparence,pH,radiochemical purity,half-life,asepsis and bacterial endotoxins of 99Tcm-TRODAT-1 injection were tested.Results The 99Tcm-TRODAT-1 kit and injection were both achromous and transparent,with pH values being 5.9 ± 0.1 and 5.5 - 7.0 respectively.The contents of stannous chloride and TRODAT-1 were stable.The labeling yield of the kit and the radiochemical purity of the injection were both ≥95％.The asepsis test demonstrated that the characters of 99Tcm-TRODAT-1 kit and injection were qualified.TRODAT-1 kit was stable at 0 -4 ℃ for 6 months or at room temperature (20 -25 ℃ )for 10 days,and the radiochemical purity of the injection was still ＞ 90％ at room temperature for 8 hours.Conclusions The quality control methods for 99Tcm-TRODAT-1 kit are simple and practical.The kit and injection are qualified and can be used for clinical application.%目的 对自制多巴胺转运蛋白显像剂99Tcm-TRODAT-1药盒及注射液进行质量控制研究.方法 对3批99 Tcm-TRODAT-1药盒及注射液进行澄清度、pH值、氯化亚锡与TRODAT-1含量、标记率、放化纯、半衰期测定,无菌以及细菌内毒素检查,可见异物、不溶性微粒检查,并分析药盒在不同存放环境下的稳定性.结果 99Tcm-TRODAT-1药盒澄清度好,pH值为5.9±0.1,药盒中氯化亚锡与TRODAT-1含量稳定,标记率大于95％.药盒在0～4℃下6个月、室温(20～25℃)下10 d内稳定性好.注射液澄清透明、pH值在5.5～7.0之间,放化纯≥95％,室温(20 ～25℃)下8h内放化纯＞90％.药盒及注射液无菌、细菌内毒素检查合格.结论 自制的99Tcm-TRODAT-1药盒及注射液的质量控制方法简便易行,药盒及注射液质量符合临床应用要求.