公开(公告)号：US20170298180A1

公开(公告)日：2017-10-19

申请号：US15513995

申请日：2015-11-26

申请人： HYBIO PHARMACEUTICAL CO., LTD.

发明人： Huixing YUAN ,  Guotao LI ,  Jian LIU ,  Yaping MA ,  Jiancheng YUAN

IPC分类号： C08G69/04 ,  C08G69/36

CPC分类号： C08G69/04 ,  C07K2/00 ,  C08G69/36

摘要： The present invention discloses a method for preparing glatiramer acetate, comprising: (1) dissolving L-alanine NCA, L-tyrosine NCA, L-glutamic acid-γ-benzyl ester NCA, and L-ε-trifluoroacetyl-lysine NCA in 1,4-dioxane as solvent, stirring until a clarified solution is formed; (2) adding diethylamine for catalysis, stirring at 20-25° C., then slowly pouring the reaction solution into water, collecting the produced white product; (3) adding the obtained product to a solution of hydrobromic acid in acetic acid, stirring at 23.0-25.0° C., pouring the reaction solution into purified water for quenching and stirring, subjecting the mixture to suction filtration to obtain a yellow solid, after repeating 3-5 times, subjecting the solid to blast drying to remove the moisture therein; and (4) dissolving the solid obtained in step (3) in a 1M piperidine aqueous solution at room temperature and stirring, subjecting the obtained solution to dialysis, adding glacial acetic acid to adjust the pH to 5.5-7.0, and lyophilizing.

公开(公告)号：US20180080909A1

公开(公告)日：2018-03-22

申请号：US15559428

申请日：2015-04-28

申请人： HYBIO PHARMACEUTICAL CO., LTD.

发明人： Yangming TANG ,  Gang HE ,  Guotao LI ,  Anjin TAO ,  Jiancheng YUAN

IPC分类号： G01N30/34 ,  G01N30/74 ,  G01N30/86 ,  G01N30/88 ,  G01N21/33 ,  G01N33/68 ,  B01D15/32 ,  B01D15/36 ,  A61K38/03

CPC分类号： G01N30/34 ,  A61K38/03 ,  B01D15/325 ,  B01D15/362 ,  B01D15/363 ,  C07K1/18 ,  C07K1/20 ,  C07K14/00 ,  G01N21/33 ,  G01N30/74 ,  G01N30/8631 ,  G01N30/88 ,  G01N33/6803 ,  G01N2030/8831

摘要： The present invention relates to a high performance liquid chromatography method for polypeptide mixtures. Specifically, the method including the following steps: step (1): preparing a solution of the glatiramer acetate to be tested; step (2): performing gradient elution on a sample to be tested with an anion exchange liquid chromatography, a cation exchange liquid chromatography, or a reversed-phase liquid chromatography; step (3): determining a peak area corresponding to each component of the glatiramer acetate, comparing the peak area with to a peak area of a reference substance to determine whether the content of each component of the sample to be tested is in a qualified range.