乙酸丁酯萃取法制备枸橼酸镓~(67)Ga注射液
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摘要: 测定了示踪浓度下Ga(Ⅲ)在HCl-乙酸丁酯体系中的分配比D。实验表明,HCl浓度为6mol/l时,D值最高,达5×10 ̄2。当相比为1,HCl浓度为5.5-8.0mol/l时,萃取率E≥98%。在相同条件下,共存的ZnCl_2浓度<2mol/l时,E不低于96%。采用乙酸丁酯萃取法从质子束照射后的Zn靶中制备枸橼酸镓[ ̄(67)Ga]注射液。萃取酸度为6mol/lHCl,Zn离子浓度≤2mol/l,萃取前用TiCl_3还原痕量Fe(Ⅲ)为Fe(Ⅱ),Ga(Ⅲ)用水反萃。产品的核纯度~100%,放化纯度>90%,Zn、Ti、Fe、Cu、Cd、Pb的浓度低于或接近1mg/l,异常毒性检查合格,各项指标均符合中国药典和美国药典要求。化学产率为(92±2)%,制备时间<3h。Abstract: PKODUCTION OF ~(67)Ga CITRATE INJECTION LIQUID WITH BUTYLACETATE EXTRACTION METHODFANG YIBING;LI BO;LIU PENG;PAN QIYUAN;LIU PEIHUA;WANG HAN;FENG JINGLING(Institute of High Energy Physics,Chinese Academy of Sciences,P.O.Box 918(11-04),Beijing 100039)ABSTRACT The distribution ratios D for Ga(Ⅲ)at trace concentration in the HCl-butylacetate extrac-tion svstem are measured.It is showed that tHe D in 6 mol/l HCl 5×10~2 which is maximum in 3-8mol/l HCl.The extraction rates E in 5.5-8mol/l HCl at phase ratio of 1 are≥98%and≥96%respectively when the concentration of ZnCl_2 in the solution are 0 and≤2mol/l.A buty-lacetate extraction method for the production of ~(67)7Ga citrate injection liquid from Zn target irradi-ated by proton beam is developed.The optimal acidity of extraction is 6 mol/l HCl.The concen-tration of ZnCl_2 is adjusted to≤2.0mol/l and the impurity of Fe(Ⅲ)in solution is reduced toFe(Ⅱ)with 10%TiCl_3 before extraction.The ~(67)Ga in organic phase is then stripped with water.The radionuclidic purity of the product is 100%while the radiochemical purity > 90%.Theamounts of Zn,Ti,Fe,Cu,Cd and Pb in the injection are below or near 1mg/l.The test of abnor-mal toxicity is negative. The quality of the injection meets the requirements of both the ChinesePharmacopoeia and the United States Pharmacopoeia. The chemical yield is(92±2)%while thetime of operation is<3h.Key words ~(67)Ga citrate injection Butylacetate Solvent extraction