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.
出处
《中华核医学杂志》
CAS
CSCD
北大核心
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）
