| 摘要 |
A nerve growth factor composition and a powder injection. The composition consists of a nerve growth factor, a stabilizer, a pH buffer, and water. The stabilizer is one of sorbierite, dextran, trehalose, raffinose and mannitol. The use of saccharides or sugar alcohols as a stabilizer instead of albumin can avoid hidden risks caused by viruses or other unknown components carried in albumins. In addition to the nerve growth factor, the composition comprises only the stabilizer and the pH buffer and does not contain any common surfactant or supporting agent, and therefore is safer and can significantly reduce the incidence of adverse reactions. 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. The stabilizer not only can protect mNGF, but also enables hNGF and rhNGF to have good stability during preparation, transportation and storage, thereby ensuring safe clinical administration and good quality control. |
