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公开(公告)号：US20180104310A1
公开(公告)日：2018-04-19
申请号：US15568453
申请日：2016-04-18
申请人： STAIDSON (BEIJING) BIOPHARMACEUTICALS CO., LTD. , BEIJING STAIDSON MEDICAL TECHNOLOGY CO., LTD.
发明人： Jianping TAN , Bingzhang WANG
IPC分类号： A61K38/18 , A61P25/00 , A61K9/19 , A61K47/26 , A61K47/36 , A61K47/24 , A61K47/14 , A61K47/18
CPC分类号： A61K38/185 , A61K9/08 , A61K9/19 , A61K38/18 , A61K47/14 , A61K47/183 , A61K47/24 , A61K47/26 , A61K47/36 , A61P25/00
摘要： The present invention discloses a nerve growth factor composition and an injection powder comprising a nerve growth factor, a stabilizer, a pH buffer, and water, wherein the stabilizer is at least one of sorbitol, dextran, trehalose, raffinose and mannitol. By using a carbohydrate or sugar alcohol as a stabilizer, the present invention can avoid the potential risk resulting from the presence of viruses or other unknown components in albumin. In addition to the nerve growth factor, only the stabilizer and the pH buffer are contained, without conventional surfactant and supporting agent, increasing safety and significantly reducing incidence of the adverse reactions. The present invention not only provides a protective effect on mNGF, but also can ensure good stability of hNGF and rhNGF in the preparation, transportation and storage processes, and has better medication safety and quality control.
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公开(公告)号：US20180161436A1
公开(公告)日：2018-06-14
申请号：US15568455
申请日：2016-04-18
申请人： STAIDSON (BEIJING) BIOPHARMACEUTICALS CO., LTD. , BEIJING STAIDSON MEDICAL TECHNOLOGY CO., LTD.
发明人： Jianping TAN , Bingzhang WANG
CPC分类号： A61K47/26 , A61K9/0019 , A61K9/08 , A61K9/19 , A61K38/18 , A61K38/185 , A61K47/183 , A61K47/36 , A61P25/00
摘要： The present invention discloses nerve growth factor composition and an injection powder comprising the following components: 10 μg/mL-100 μg/mL of a nerve growth factor; 10 mg/mL-80 mg/mL of disaccharide stabilizer; 0 mg/mL-30 mg/mL of an amino acid stabilizer; 0.01 mg/mL-1 mg/mL of surfactant, 10 mg/mL-50 mg/mL of a supporting agent; a pH buffer for maintaining the nerve growth factor composition at 6.0-7.4, and solvent being water. The nerve growth factor composition and the injection powder can avoid the potential risk resulting from the virus of other unknown components carried in albumin by using a disaccharide or a combination of a disaccharide and an amino acid instead of albumin as a stabilizer; not only have protective effect on mNGF, but also can ensure the stability of hNGF and rhNGF in the preparation, transportation and storage processes, and have better medication safety and quality control.
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公开(公告)号：US20180110833A1
公开(公告)日：2018-04-26
申请号：US15568450
申请日：2016-04-18
申请人： STAIDSON (BEIJING) BIOPHARMACEUTICALS CO., LTD. , BEIJING STAIDSON MEDICAL TECHNOLOGY CO., LTD.
发明人： Jianping TAN , Bingzhang WANG
CPC分类号： A61K38/185 , A61K9/08 , A61K9/19 , A61K38/18 , A61K47/14 , A61K47/183 , A61K47/26 , A61K47/36 , A61P25/00
摘要： The present invention discloses a nerve growth factor composition and an injection powder comprising a nerve growth factor, a stabilizer, a supporting agent, a pH buffer, water and optionally a surfactant. The stabilizer may be selected from arginine, glutamic acid, glycine and isoleucine. By using an amino acid instead of albumin as a stabilizer, the nerve growth factor composition and the injection powder can avoid the potential risk of viral or other unknown components carried in albumin, ensuring the stability of hNGF and rhNGF during preparation, transportation and storage processes, and allowing for increased safety and quality control.
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