Beijing Staidson Medical Technology Co., Ltd.;Staidson Beijing Biopharmaceuticals Co. Ltd.
发明人:
TAN, Jianping,WANG, Bingzhang
申请号：
EP16782601
公开号：
EP3287140A4
申请日:
2016.04.18
申请国别(地区):
EP
年份:
2018
代理人:
摘要：
The present invention discloses a nerve growth factor composition and an injection powder. The nerve growth factor composition comprises the following components: 10 µg/mL-100 µg/mL of a nerve growth factor； 10 mg/mL-80 mg/mL of a disaccharide stabilizer； 0 mg/mL-30 mg/mL of an amino acid stabilizer； 0.01 mg/mL-1 mg/mL of a surfactant； 10 mg/mL-50 mg/mL of a supporting agent； a pH buffer for maintaining said nerve growth factor composition at pH value of 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 or 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 good stability of hNGF and rhNGF in the preparation, transportation and storage processes, and have better clinical medication safety and quality controllability； have definite ingredients, are easily qualitative and quantitative and the stabilizer used therein has a high purity, a wide source and easy long-term mass production, which facilitate the cost control and the product quality improvement.
