Ganciclovir composition for injection and freeze drying process of ganciclovir composition
A technology of ganciclovir and drying process, applied in the field of ganciclovir composition for injection and its freeze-drying process, can solve the problems such as difficult removal of water, easy collapse and shrinkage of structure, prolonged freeze-drying cycle, etc. It is not easy to remove, the prescription is simple and reasonable, and the effect of prolonging the freeze-drying cycle
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Embodiment 1
[0028] (1) Prepare 80% water for injection in the container; add 40.3g sodium hydroxide and stir to dissolve; add 250g (166.7mg / ml) ganciclovir and stir to dissolve; add 10% hydrochloric acid solution to adjust the pH value to 11.2, and then Add water for injection to 1.5 L, stir evenly to obtain Ganciclovir liquid medicine, and liquid medicine obtains Ganciclovir sample after aseptic filtration and canning (1.5mL / bottle).
[0029] (2) The ganciclovir samples were pre-frozen. During pre-freezing, the plate layer was rapidly cooled from room temperature to -45°C and kept for 1.5 hours, with a cooling rate of 75°C / h. The pre-frozen ganciclovir samples were subjected to sublimation drying. During sublimation drying, the plate layer was heated from -45°C to -30°C and kept for 9 hours. environment. The ganciclovir after sublimation drying is analyzed and dried. During the analysis and drying, the temperature of the plate layer is raised from -30°C to 50°C and kept for 4 hours. in...
Embodiment 2
[0031] (1) Prepare 80% water for injection in the container; add 37.1g sodium hydroxide and stir to dissolve; add 230g (153.3mg / ml) ganciclovir and stir to dissolve; add 10% hydrochloric acid solution to adjust the pH value to 11.3, then Add water for injection to 1.5 L, stir evenly to obtain Ganciclovir liquid medicine, and liquid medicine obtains Ganciclovir sample after aseptic filtration and canning (1.5mL / bottle).
[0032] (2) The ganciclovir samples were pre-frozen. During pre-freezing, the plate layer was rapidly cooled from room temperature to -45°C and kept for 1 hour, with a cooling rate of 70°C / h. The pre-frozen ganciclovir samples were subjected to sublimation drying. During sublimation drying, the plate layer was heated from -45°C to -30°C and kept for 10 hours. environment. The ganciclovir after sublimation drying is analyzed and dried. During the analysis and drying, the temperature of the plate layer is raised from -30°C to 50°C and kept for 3 hours. in progr...
Embodiment 3
[0034] (1) Prepare 80% water for injection in the container; add 41.9g sodium hydroxide and stir to dissolve; add 260g (173.3mg / ml) ganciclovir and stir to dissolve; add 10% hydrochloric acid solution to adjust the pH value to 11.5, then Add water for injection to 1.5 L, stir evenly to obtain Ganciclovir liquid medicine, and liquid medicine obtains Ganciclovir sample after aseptic filtration and canning (1.5mL / bottle).
[0035] (2) The ganciclovir samples were pre-frozen. During pre-freezing, the plate layer was rapidly cooled from room temperature to -45°C and kept for 2 hours, with a cooling rate of 80°C / h. The pre-frozen ganciclovir samples were subjected to sublimation drying. During sublimation drying, the plate layer was heated from -45°C to -30°C and kept for 8 hours. The heating rate was 5°C / h. environment. The ganciclovir after sublimation drying is analyzed and dried. During the analysis and drying, the temperature of the plate layer is raised from -30°C to 50°C and...
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