公开(公告)号：US20210387971A1

公开(公告)日：2021-12-16

申请号：US17291237

申请日：2018-11-06

申请人： Zhejiang Huahai Pharmaceutical Co., Ltd ,  Zhejiang Huahai Zhicheng Pharmaceutical Co., Ltd.

发明人： Jinsheng LIN ,  Xiaofei LIU ,  Dan LI ,  Jing WANG ,  Yue LI ,  Wenquan ZHU ,  Wenbin CHEN ,  Min LI

IPC分类号： C07D403/06

摘要： Provided are a pregabalin lactam methylene dimer and a preparation method therefor. The method comprises the following steps: dissolving pregabalin in a reaction solvent, reacting same with an aldehyde in an acidic system and isolating the obtained target product pregabalin lactam methylene dimer. The preparation method for pregabalin lactam methylene dimer provided by the present application has a simple operation, a high product yield, a good purity and a low cost.

公开(公告)号：US20200306245A1

公开(公告)日：2020-10-01

申请号：US16647847

申请日：2017-09-20

申请人： Zhejiang Huahai Pharmaceutical Co., Ltd

发明人： Jinsheng LIN ,  Tianpei HUANG ,  Feifei LAN ,  Xiaoyan XU ,  Libin HU ,  Dan LI ,  Wenquan ZHU ,  Min LI ,  Zhiyun WANG

IPC分类号： A61K31/4965 ,  A61K47/38

摘要： Disclosed is N-formyl vortioxetine, and also disclosed is a method for preparing the N-formyl vortioxetine and a stable solid preparation of vortioxetine.

公开(公告)号：US20210285920A1

公开(公告)日：2021-09-16

申请号：US17258226

申请日：2018-07-10

申请人： Zhejiang Huahai Pharmaceutical Co., Ltd

发明人： Tan XIAO ,  Tianpei HUANG ,  Jinsheng LIN ,  Qiang ZHOU ,  Tong WU ,  Danfeng YE ,  Hong CAI ,  Wenquan ZHU ,  Wenbin CHEN ,  Min LI

IPC分类号： G01N30/72 ,  G01N30/88

摘要： Disclosed is a detection method for N-nitrosodimethylamine (NDMA) impurities, comprising: (1) obtaining a test solution containing a sample to be tested; and (2) detecting the test solution by means of gas chromatography-mass spectrometry to determine the content of an N-nitrosodimethylamine impurity in the sample. The method provided in the present invention has a good separating effect, a wide linear range, a high sensitivity and a good method durability, and can detect the content of N-nitrosodimethylamine (NDMA) in the sample rapidly and effectively.

公开(公告)号：US20210269408A1

公开(公告)日：2021-09-02

申请号：US17259292

申请日：2018-07-17

申请人： Zhejiang Huahai Pharmaceutical Co., Ltd

发明人： Xiaohui ZHOU ,  Xiaoren ZHU ,  Yuanxun ZHU ,  Peng DONG ,  Peng WANG ,  Jinsheng LIN ,  Wenquan ZHU ,  Min LI

IPC分类号： C07D257/04

摘要： A method for synthesizing valsartan, comprising the steps of: synthesizing a valsartan methyl ester intermediate to obtain a reaction mixture of the valsartan methyl ester intermediate; diluting the reaction mixture by salt water or water, and then using a first extraction solvent to extract the valsartan methyl ester intermediate; adding alkali to an organic layer containing the valsartan methyl ester intermediate for hydrolyzing, removing the organic layer, regulating pH of a water layer to be acidic by using acid, using the first extraction solvent to extract, concentrating a part of solvent, or distilling the solvent to dryness, and then adding a new solvent; finally, crystallizing, filtering, and drying to obtain the valsartan.