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目的 建立心肌灌注显像剂99TcmN 甲氧基异丁基异腈 (MIBI)的药盒法制备及其质量控制方法。方法 由条件实验确定药盒中各组分的最佳含量。参照《中国药典》(1995年版 )方法进行澄清度、pH值、无菌以及急性毒性检查。将药盒置于不同环境下存放不同时间 ,通过外观、主药含量及配合物标记率的变化来检查药盒的稳定性。结果 药盒的澄清度、pH值、无菌以及急性毒性检查合格 ,稳定性好。药盒法制备的配合物标记率大于 95 %。结论 药盒法制备99TcmN MIBI配合物简便易行 ,符合临床试用要求。
Objective To establish a kit for preparation of myocardial perfusion imaging agent 99TcmN methoxyisobutyl isonitrile (MIBI) and its quality control method. Methods The optimum conditions for each component of the kit were determined by the experimental conditions. Reference to “Chinese Pharmacopoeia” (1995 edition) method for clarity, pH, sterility and acute toxicity test. The kit was placed in different environments stored at different times, through the appearance, the main drug content and the change of complex labeling rate to check the stability of the kit. Results Kit clarity, pH, sterile and acute toxicity test qualified, good stability. Kits prepared by the kit labeling rate greater than 95%. Conclusion The kit of 99TcmN MIBI prepared by kit method is simple and convenient, which meets the requirements of clinical trial.