DDDC-乙酸丁酯联合萃取法制备~(201)TICI注射液

    • 摘要: 研究了二乙基二硫代氨基甲酸二乙铵(DDDC)对低浓度Pb、Tl(I)的萃取条件。在此基础上,发展了DDDC-乙酸丁酯联合萃取法,从能量为29-22MeV、流强≤20μA的质子束辐照后的金属铊靶中制备 ̄(201)TICI注射液。18批总量为3.18×10 ̄(10)Bq的制备工作表明,产品的质量满足美国药典要求。化学产率84%±2%,分离时间2.5-3h,还可用于 ̄(203)pb的制备。注射液的异常毒性合格,小鼠体内分布和家兔显像实验结果良好。完成了临床124例验证实验,心肌显像清晰,诊断效果良好,受试人无任何不良反应。产品已获得卫生部颁发的新药证书。

       

      Abstract: PRODUCTION OF ~(201)TICI INJECTION WITH DIETHYLAMMONIUM DIETHYLDITHIOCARBAMATE- BUTYLACETATATE EXTRACTION METHODFANG YIBING;FU YONGHANG;MIAO LIN ZHAO YONGJUN;PAN QIYUAN;LI BO LIU PEIHUA;WANG HAN;FENG JINGLING GUO XINMING;ZHANG SU;CHEN HONGTAO(Institute of High Energy Physics,Academia Sinica,Beijing,100039)ABSTRACT The extraction of Pb and Tl(Ⅰ)with butylacetate solution of diethylammonium di-ethyldithiocarbamate(DDDC)is studied.The DDDC-butylacetate extraction method for~(201)TlCI injection production from natural Tl target irradiated by 29-22 MeV proton beam isdeveloped.~(201) pb is separated from 0.3-0.4mol/l HNO_3 solution of Tl target with 0.2%DDDC-butylacetate and stripped into 4. 5mol/l HCl. The accumulated ~(201)Tl is then oxidatedto Tl(Ⅲ)with KBrO_3 and separated from Pb-activity with butylacetate extraction and final-ly ,is stripped back into diluted H2SO_3. The results of 18 production runs of total amount3.18 × 10~(10)Bq show that the quality of all injections meets the requirements of the UnitedStates Pharmacopeia. The chemical yield is 84%±2%, while the chemical separation time is2.5-3h. The method can also be used for production of ~(203)pb with the chemical yield of 84%±3%and nuclear purity of>99.9%。The results of safety test, biodistribution in mice andrabbit imaging of the injections are good. The clinical experiments of 124 cases are per-formed. The quality of myocardial images and the efficiency of diagnoses are satisfactory. Key words ~(201)TlCI injection ~(203)pb DDDC Butylacetate Solvent extrac- tion

       

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