| abstract |
The present invention relates to the technical field of medicine preparation, and provides a preparation method for a sisomicin sulfate sterile powder injection for injection. The preparation method comprises: under the protection of inert gas, taking water for injection, adding an antioxidant for dissolution, then cooling down to 20°C or below, adding sisomicin sulfate for dissolution, adjusting a pH value to 5.0-5.5, then decoloring, sterilizing and filtering, cooling down to 0-5°C, slowly dropping ethanol for solvent crystallization, and drying obtained crystals to obtain the sisomicin sulfate sterile powder injection for injection. According to the present invention, the sisomicin sulfate sterile powder injection for injection is prepared by selecting proper process conditions and using a solvent crystallization method, and the obtained product is good in stability, low in impurity content, high in safety, excellent in resolubility, and beneficial to long-term storage. |