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    NOVEL PROINSULIN GLARGINE AND METHOD FOR PREPARING INSULIN GLARGINE THEREFROM
    1.
    发明公开
    NOVEL PROINSULIN GLARGINE AND METHOD FOR PREPARING INSULIN GLARGINE THEREFROM 审中-公开

    公开(公告)号：EP4206220A1

    公开(公告)日：2023-07-05

    申请号：EP20953153.2

    申请日：2020-12-24

    申请人： AMPHASTAR NANJING PHARMACEUTICALS, INC.

    发明人： TANG, Chuangen ,  WANG, Jing ,  PAN, Shangshu ,  FAN, Xiaoyang ,  LIU, Xiaorui ,  CHEN, Song ,  ZHANG, Haoning

    IPC分类号： C07K14/62 ,  C12N15/11

    摘要： The present invention discloses novel proinsulin glargine and a method for preparing insulin glargine therefrom, and belongs to the technical field of recombinant protein preparation. According to the present invention, a sequence of the proinsulin glargine containing SOD fusion peptide subjected to site-directed mutagenesis and "0 C peptide" is designed; recombinant Escherichia coli engineering bacteria for expressing insulin glargine are constructed; insulin glargine fusion protein in a form of an inclusion body is expressed by inducing the engineering bacteria; and denaturation, renaturation, modification, enzyme digestion, separation and purification are carried out to obtain a mature insulin glargine active pharmaceutical ingredient. According to the present invention, the SOD fusion peptide sequence is mutated to enhance the fermentation yield of the insulin glargine by 75%; and a "0 C peptide" strategy is adopted to avoid remaining of C-peptide residues and reduce the quality loss and miscleavage impurities in the enzyme digestion transformation. The purity of the insulin glargine active pharmaceutical ingredient prepared in the present invention is up to 99.9%, and the maximum single impurity content is controlled at 0.05%.

    METHODS OF RESOLVING RACEMIC MIXTURE TO OBTAIN (-)-HUPERZINE A
    2.
    发明公开
    METHODS OF RESOLVING RACEMIC MIXTURE TO OBTAIN (-)-HUPERZINE A 审中-公开
    方法解决混合混合获得（ - ） - HUPERZINE A

    公开(公告)号：EP3215492A1

    公开(公告)日：2017-09-13

    申请号：EP15846276.2

    申请日：2015-09-30

    申请人： Amphastar Nanjing Pharmaceuticals Inc.

    发明人： XU, Yonggang ,  WEI, Hao ,  CHEN, Song ,  ZHANG, Haoning

    IPC分类号： C07D221/22 ,  C07D221/06 ,  A61K31/439 ,  A61K31/4748

    CPC分类号： C07D221/22 ,  C07D471/12

    摘要： A method of resolving a racemic mixture of (±)-Huperzine A to (−)-Huperzine A includes: separating the (−)-Huperzine A from the racemic mixture of (±)-Huperzine A by chiral high performance liquid chromatography (HPLC), the chiral HPLC being performed utilizing a mobile phase including a solution including an alcohol and one selected from dichloromethane, trichloromethane, and a mixture thereof, and the chiral HPLC being performed utilizing a chiral stationary phase including a polysaccharide derivative.

    摘要翻译： （±） - 石杉碱甲至（ - ） - 石杉碱甲的外消旋混合物的拆分方法包括：通过手性高效液相色谱法（HPLC）从（±） - 石杉碱甲的外消旋混合物中分离（ - ） - 石杉碱甲 ），手性HPLC使用包括含有醇和选自二氯甲烷，三氯甲烷及其混合物的溶液的流动相进行，手性HPLC使用包含多糖衍生物的手性固定相进行。

    METHOD OF PURIFYING IDRAPARINUX SODIUM
    7.
    发明公开
    METHOD OF PURIFYING IDRAPARINUX SODIUM 审中-公开
    净化IDRAPARINUX SODIUM的方法

    公开(公告)号：EP3201210A2

    公开(公告)日：2017-08-09

    申请号：EP15846879.3

    申请日：2015-09-30

    申请人： Amphastar Nanjing Pharmaceuticals Inc.

    发明人： MENG, Jundong ,  XU, Yonggang ,  WANG, Wencun ,  CHEN, Song ,  WANG, Haoning

    IPC分类号： C07H15/04 ,  C07H15/18 ,  C07H15/14

    CPC分类号： C07H1/06 ,  C07H15/04

    摘要： A method for the purification of idraparinux sodium includes: passing a solution including a crude idraparinux sodium through a column including a sodium ion exchange resin to obtain a first mixture; passing a solution including the first mixture through a gel chromatogaphy column to obtain a second mixture; and precipitating a purified idraparinux sodium from a solution including the second mixture.

    摘要翻译： 用于精制伊达拉滨克斯钠的方法包括：使包含粗伊达令林钠的溶液通过包含钠离子交换树脂的柱以获得第一混合物; 将包含第一混合物的溶液通过凝胶色谱柱以获得第二混合物; 并从包含第二混合物的溶液中沉淀纯化的伊达肝素钠。

    METHOD OF PREPARING INTERMEDIATE OF SALMETEROL
    9.
    发明公开
    METHOD OF PREPARING INTERMEDIATE OF SALMETEROL 审中-公开
    制备中间体SALMETEROL的方法

    公开(公告)号：EP3201171A1

    公开(公告)日：2017-08-09

    申请号：EP15847357.9

    申请日：2015-09-30

    申请人： Amphastar Nanjing Pharmaceuticals Inc.

    发明人： QIU, Yinhua ,  WU, Zhengyuan ,  CHEN, Song ,  ZHANG, Haoning

    IPC分类号： C07C213/08 ,  C07C213/10 ,  C07C217/10 ,  C07C217/28 ,  C07C217/40

    CPC分类号： C07D319/08 ,  C07C213/00

    摘要： A method of preparing an intermediate of salmeterol (Compound 1, 2-amino-1-(2,2-dimethyl-4H-1,3-benzodioxin-6-yl)ethanol) includes: reacting compound 2 with 2-methoxypropene in a first organic solvent to produce a reaction solution including compound 3, compound 2 including a 2-bromo precursor of Compound 1; reacting compound 3 with a nitrogen source to produce compound 4; reacting compound 4 with sodium borohydride in a second organic solvent to produce compound 5; and debenzylating compound 5 by ammonium formate/palladium-carbon catalytic transfer hydrogenation in a third organic solvent to produce Compound 1. A method of preparing salmeterol includes preparing Compound 1, and reacting Compound 1 to prepare salmeterol.

    摘要翻译： 制备沙美特罗中间体（化合物1,2-氨基-1-（2,2-二甲基-4H-1,3-苯并二恶英-6-基）乙醇）的方法包括：使化合物2与2-甲氧基丙烯在 第一有机溶剂中以产生包含化合物3，化合物2（包括化合物1的2-溴前体）的反应溶液; 使化合物3与氮源反应以产生化合物4; 使化合物4与硼氢化钠在第二有机溶剂中反应以产生化合物5; 并在第三有机溶剂中通过甲酸铵/钯 - 碳催化转移氢化将化合物5去苄基化以产生化合物1.制备沙美特罗的方法包括制备化合物1，并使化合物1反应以制备沙美特罗。