多巴胺转运蛋白显像剂^99Tc^m—TRODAT-1药盒及注射液的质量控制  

Quality control of the kit and injection of ^99Tc^m-TRODAT-1 as a dopamine transporter imaging agent

作　　者：唐婕[1] 陈正平[1] 李晓敏[1] 刘春仪[1] 黄旭荃[1] 李卫一[1] 邹美芬[1] 徐希杰[1] 

机构地区：[1]江苏省原子医学研究所、卫生部核医学重点实验室、江苏省分子核医学重点实验室,江苏省无锡市214063

出　　处：《中华核医学杂志》2011年第6期414-416,共3页Chinese Journal of Nuclear Medicine

基　　金：国家自然科学基金（30970844）;江苏省自然科学基金（BK2010155）;江苏省高技术研究计划（BG2007603）

摘　　要：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^99Tc^m-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^99Tc^m-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10d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^99Tc^m-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。Objective To study the quality control methods for ^99Tc^m-TRODAT-1 kit and injec- tion. Methods The appearance, pH, contents of the bases, the labeling yield, asepsis and bacterial endotoxins of ^99Tc^m-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 ^99Tc^m-TRODAT-1 injection were tested. Results The ^99Tc^m-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 ^99Tc^m-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 ^99Tc^m-TRODAT-1 kit are simple and practical. The kit and injection are qualified and can be used for clinical application.

关 键 词：多巴胺 TRODAT-1 锝 质量控制 

分 类 号：R742.5[医药卫生—神经病学与精神病学]