CAJ | 학술논문

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.
목적 대자제다파알전운단백현상제99Tcm-TRODAT-1약합급주사액진행질량공제연구.방법 대3비99 Tcm-TRODAT-1약합급주사액진행징청도、pH치、록화아석여TRODAT-1함량、표기솔、방화순、반쇠기측정,무균이급세균내독소검사,가견이물、불용성미립검사,병분석약합재불동존방배경하적은정성.결과 99Tcm-TRODAT-1약합징청도호,pH치위5.9±0.1,약합중록화아석여TRODAT-1함량은정,표기솔대우95％.약합재0～4℃하6개월、실온(20～25℃)하10 d내은정성호.주사액징청투명、pH치재5.5～7.0지간,방화순≥95％,실온(20 ～25℃)하8h내방화순＞90％.약합급주사액무균、세균내독소검사합격.결론 자제적99Tcm-TRODAT-1약합급주사액적질량공제방법간편역행,약합급주사액질량부합림상응용요구.
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.