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    Direct solid sample analytical technology for determining a content and a uniformity thereof in a lyophilized kit of a sulfur-containing chelator with a stable complex capacity for radiotechnetium (Tc-99M) and radiorhenium (Re-186, Re-188)
    1.
    发明授权
    Direct solid sample analytical technology for determining a content and a uniformity thereof in a lyophilized kit of a sulfur-containing chelator with a stable complex capacity for radiotechnetium (Tc-99M) and radiorhenium (Re-186, Re-188) 有权
    用于确定具有稳定的放射性核磁共振能力（Tc-99M）和镭（Re-186，Re-188）的含硫螯合剂的冻干试剂盒中的含量和均匀性的直接固体样品分析技术，

    公开(公告)号：US08831891B2

    公开(公告)日：2014-09-09

    申请号：US13273346

    申请日：2011-10-14

    申请人： Kung-Tien Liu ,  Ming-Yu Chao ,  Yi-Chih Hsia ,  Shih-Woei Yeh ,  Mei-Hsiu Liao ,  Lee-Chung Men ,  Lie-Hang Shen

    发明人： Kung-Tien Liu ,  Ming-Yu Chao ,  Yi-Chih Hsia ,  Shih-Woei Yeh ,  Mei-Hsiu Liao ,  Lee-Chung Men ,  Lie-Hang Shen

    IPC分类号： A61K51/04

    CPC分类号： A61K51/0478

    摘要： The present invention is related to a direct solid sample analytical technology for determining a content and a uniformity thereof in a lyophilized kit of a sulfur-containing chelator with a stable complex capacity for radiotechnetium (Tc-99m) and radiorhenium (Re-186, Re-188). An economical, stable and easily accessible coal standard is used herein as a contrast substance to construct a sulfur calibration curve, followed by obtaining the sulfur content and the uniformity thereof in the solid lyophilized sample by interpolating the foregoing result into the sulfur calibration curve. Then, the weight content percent is converted to get the content and the uniformity of the chelator in the lyophilized kit. The quality control of active pharmaceutical ingredients (API) in the lyophilized kit during key production processes and clinical applications is thus assured.

    摘要翻译： 本发明涉及一种直接固体样品分析技术，用于确定具有稳定的放射性核磁共振能力（Tc-99m）和镭（Re-186，Re）的含硫螯合剂的冻干试剂盒中的含量和均匀性 -188）。 本文中使用经济，稳定且易于获得的煤标准作为对比物质来构建硫校准曲线，随后通过将上述结果内插到硫校准曲线中来获得固体冻干样品中的硫含量及其均匀性。 然后，将重量含量百分比转化为获得冻干试剂盒中螯合剂的含量和均匀性。 因此，确保了关键生产过程和临床应用中冻干试剂盒中活性药物成分（API）的质量控制。

    DIRECT SOLID SAMPLE ANALYTICAL TECHNOLOGY FOR DETERMINING A CONTENT AND A UNIFORMITY THEREOF IN A LYOPHILIZED KIT OF A SULFUR-CONTAINING CHELATOR WITH A STABLE COMPLEX CAPACITY FOR RADIOTECHNETIUM (TC-99M) AND RADIORHENIUM (RE-186, RE-188)
    2.
    发明申请
    DIRECT SOLID SAMPLE ANALYTICAL TECHNOLOGY FOR DETERMINING A CONTENT AND A UNIFORMITY THEREOF IN A LYOPHILIZED KIT OF A SULFUR-CONTAINING CHELATOR WITH A STABLE COMPLEX CAPACITY FOR RADIOTECHNETIUM (TC-99M) AND RADIORHENIUM (RE-186, RE-188) 有权
    用于确定具有稳定的放射性复合容量（TC-99M）和放射性阳离子（RE-186，RE-188）的具有稳定复合容量的含硫化合物的LYOPHILIZED试剂盒中的内容物和其均匀性的直接固体样品分析技术

    公开(公告)号：US20120101741A1

    公开(公告)日：2012-04-26

    申请号：US13273346

    申请日：2011-10-14

    申请人： KUNG-TIEN LIU ,  Ming-Yu Chao ,  Yi-Chih Hsia ,  Shih-Woei Yeh ,  Mei-Hsiu Liao ,  Lee-Chung Men ,  Lie-Hang Shen

    发明人： KUNG-TIEN LIU ,  Ming-Yu Chao ,  Yi-Chih Hsia ,  Shih-Woei Yeh ,  Mei-Hsiu Liao ,  Lee-Chung Men ,  Lie-Hang Shen

    IPC分类号： G06F19/00

    CPC分类号： A61K51/0478

    摘要： The present invention is related to a direct solid sample analytical technology for determining a content and a uniformity thereof in a lyophilized kit of a sulfur-containing chelator with a stable complex capacity for radiotechnetium (Tc-99m) and radiorhenium (Re-186, Re-188). An economical, stable and easily accessible coal standard is used herein as a contrast substance to construct a sulfur calibration curve, followed by obtaining the sulfur content and the uniformity thereof in the solid lyophilized sample by interpolating the foregoing result into the sulfur calibration curve. Then, the weight content percent is converted to get the content and the uniformity of the chelator in the lyophilized kit. The quality control of active pharmaceutical ingredients (API) in the lyophilized kit during key production processes and clinical applications is thus assured.

    摘要翻译： 本发明涉及一种直接固体样品分析技术，用于确定具有稳定的放射性核磁共振能力（Tc-99m）和镭（Re-186，Re）的含硫螯合剂的冻干试剂盒中的含量和均匀性 -188）。 本文中使用经济，稳定且易于获得的煤标准作为对比物质来构建硫校准曲线，随后通过将上述结果内插到硫校准曲线中来获得固体冻干样品中的硫含量及其均匀性。 然后，将重量含量百分比转化为获得冻干试剂盒中螯合剂的含量和均匀性。 因此，确保了关键生产过程和临床应用中冻干试剂盒中活性药物成分（API）的质量控制。