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。
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关键词:
- 枸橼酸镓［￣（６７）Ｇａ］ /
- 乙酸丁酯 /
- 溶剂萃取
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 -
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[1] １ＨｕｐｆＨＢ，ＢｅａｖｅｒＪＥ．ＣｙｃｌｏｔｒｏｎＰｒｏｄｕｃｔｉｏｎｏｆＣａｒｒｉｅｒ－ＦｒｅｅＧａｌｌｉｕｍ－６７．ＩｎｔＪＡｐｐｌＲａｄｉａｔＩｓｏｔ，１９７０，２１（２）：７５．２ＢｒｏｗｎＬＣ．ＣｈｅｍｉｃａｌＰｒｏｃｅｓｓｉｎｇｏｆＣｙｃｌｏｔｒｏｎ－ｐｒｏｄｕｃｅｄ￣（６７）Ｇａ．ＩｎｔＪＡｐｐｌＲａｄｉａｔＩｓｏｔ，１９７１，２２（１１）：７１０．３陈声洋，张留芳，刘景芝，等．回旋加速器制备放射性枸橼酸镓[￣（６７）Ｇａ]注射液．核技术，１９８０，３（３）：１５．４王中央，范我，牛芳，等．锗－６－镓－６８同位素发生器，原子能科学技术，１９８０，１４（２）：１８３．５中华人民共和国卫生部药典委员会，中华人民共和国药典１９９０年版二部．北京：化学工业出版社和人民卫生出版社，１９９０．３４６．６ＤｅｂｅｒｔｉｎＫ，ＰｅｓｓａｒａＷ，ＳｃｈｏｔｚｉｇＵ，ｅｔａｌ．ＤｅｃａｙＤａｔａｏｆ￣（６７）Ｇａａｎｄ￣（２０１）Ｔｌ．ＩｎｔＪＡｐｐｌＲａｄｉａｔＩｓｏｔ，１９７９，３０（９）：５５１．７ＴｈｅＵｎｉｔｅｄＳｔａｔｅｓＰｈａｒｍａｃｏｐｅｉａ，２１Ｒｅｖｉｓｉｏｎ，ＴｈｅＮａｔｉｏｎａｌＦｏｒｍｕｌａｒｙ．１６ｅｄ．ＯｆｆｉｃｉａｌＦｒｏｍＪａｎｕａｒｙ１，１９８５．Ｒｏｃｋｖｉｌｌｅ：ＴｈｅＵｎｉｔｅｄＳｔａｔｅｓＰｈａｒｍａｃｏｐｅｉａｌＣｏｎｖｅｎｔｉｏｎ，Ｉｎｃ，１９８４．４５４．８ＩｓｈｉｍｏｒｉＴ．ＡｋａｔｓｕＥ，ＴｓｕｋｕｅｃｈｉＫ，ｅｔａｌ．ＤａｔａｏｆＩｎｏｒｇａｎｉｃＳｏｌｖｅｎｔＥｘｔｒａｃｔｉｏｎ：ＪＡＥＲＬＩ－１１０６．Ｔｏｋｙｏ：ＪａｐａｎＡｔｏｍｉｃＥｎｅｒｇｙＲｅｓｅａｒｃｈＩｎｓｔｉｔｕｔｅ，１９６６．２０．
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