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Title:
NERVE GROWTH FACTOR COMPOSITION AND POWDER INJECTION
Document Type and Number:
WIPO Patent Application WO/2016/169454
Kind Code:
A1
Abstract:
A nerve growth factor composition and a powder injection. The nerve growth factor composition comprises the following components: 10μg/mL to 100μg/mL of nerve growth factor, 10mg/mL to 80mg/mL of disaccharide stabilizer, 0mg/mL to 30mg/mL amino acid stabilizer, 0.01mg/mL to 1mg/mL of surfactant, 10mg/mL to 50mg/mL of supporting agent, a pH buffer for maintaining the pH of the nerve growth factor composition at 6.0 to 7.4, and a solvent water. In the nerve growth factor composition and the powder injection, the use of disaccharide or a combination of the disaccharides and the amino acid as a stabilizer instead of albumin can avoid hidden risks due to viruses or other unknown components carried in the albumin. The stabilizer not only can protect mNGF, but also enables hNGF and rhNGF to have good stability during preparation, transportation and storage, thereby ensuring safer clinical administration and better quality control. The components of the composition are known and can be easily determined qualitatively and quantitatively. The stabilizer used has a high purity and has a wide range of sources, facilitating mass production in a long term and making it easy to control the costs and improve product quality.

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Inventors:
TAN JIANPING (CN)
WANG BINGZHANG (CN)
Application Number:
PCT/CN2016/079571
Publication Date:
October 27, 2016
Filing Date:
April 18, 2016
Export Citation:
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Assignee:
STAIDSON (BEIJING) BIOPHARMACEUTICALS CO LTD (CN)
BEIJING STAIDSON NEW PHARMACEUTICALS CO LTD (CN)
International Classes:
A61K9/08; A61K38/18; A61K9/19; A61P25/00
Domestic Patent References:
WO2007073035A12007-06-28
Foreign References:
CN1552440A2004-12-08
CN1133012A1996-10-09
CN1824297A2006-08-30
CN1857718A2006-11-08
CN101972224A2011-02-16
CN101461786A2009-06-24
Other References:
See also references of EP 3287140A4
Attorney, Agent or Firm:
JEEKAI & PARTNERS (CN)
北京纪凯知识产权代理有限公司 (CN)
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