A kind of ganciclovir composition for injection and preparation method thereof
A technology of ganciclovir and composition, applied in the field of ganciclovir composition for injection and its preparation, can solve the problems of no improvement and the like, and achieve the effects of good safety, uniform and stable quality, and thorough moisture drying
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Embodiment 1
[0087] prescription:
[0088] Ganciclovir 2.5Kg
[0089] Sodium hydroxide 368g
[0090] Add water for injection to 25Kg
[0091] Preparation: Weigh ganciclovir and sodium hydroxide, put them in a preparation tank, add water for injection, stir to dissolve completely and mix evenly;
[0092] Sterile filtration and sub-packaging: filter the medicinal solution into a sterile room with a 0.22 μm microporous filter, sub-package into vials at a volume of 2.5ml / bottle, and half-stopper;
[0093] Vacuum Freeze Drying:
[0094] a. Pre-freezing: Put the subpackaged ganciclovir liquid into the freeze dryer to quickly reduce the temperature of the product. When the temperature of the product is lower than -45°C, continue to freeze for 60 minutes to completely freeze the ganciclovir liquid ;
[0095] b. Cooling of the rear box: use the compressor to cool the cold trap of the rear box, so that the temperature of the cold trap of the rear box is lower than -70°C;
[0096] c. Vacuuming:...
Embodiment 2
[0101] prescription:
[0102] Ganciclovir 2.5Kg
[0103] Sodium hydroxide 357g
[0104] Add water for injection to 25Kg
[0105] Preparation: Weigh ganciclovir and sodium hydroxide, put them in a preparation tank, add water for injection, stir to dissolve completely and mix evenly;
[0106] Sterile filtration and sub-packaging: filter the medicinal solution into a sterile room with a 0.22 μm microporous filter, sub-package into vials at a volume of 2.5ml / bottle, and half-stopper;
[0107] Vacuum Freeze Drying:
[0108] a. Pre-freezing: Put the subpackaged ganciclovir liquid into the freeze dryer to quickly reduce the temperature of the product. When the temperature of the product is lower than -45°C, continue to freeze for 60 minutes to completely freeze the ganciclovir liquid ;
[0109] b. Cooling of the rear box: use the compressor to cool the cold trap of the rear box, so that the temperature of the cold trap of the rear box is lower than -70°C;
[0110] c. Vacuuming:...
Embodiment 3
[0115] prescription:
[0116] Ganciclovir 2.5Kg
[0117] Sodium hydroxide 379g
[0118] Add water for injection to 25Kg
[0119] Preparation: Weigh ganciclovir and sodium hydroxide, put them in a preparation tank, add water for injection, stir to dissolve completely and mix evenly;
[0120] Sterile filtration and sub-packaging: filter the medicinal solution into a sterile room with a 0.22 μm microporous filter, sub-package into vials at a volume of 2.5ml / bottle, and half-stopper;
[0121] Vacuum Freeze Drying:
[0122] a. Pre-freezing: Put the subpackaged ganciclovir liquid into the freeze dryer to quickly reduce the temperature of the product. When the temperature of the product is lower than -45°C, continue to freeze for 60 minutes to completely freeze the ganciclovir liquid ;
[0123] b. Cooling of the rear box: use the compressor to cool the cold trap of the rear box, so that the temperature of the cold trap of the rear box is lower than -70°C;
[0124] c. Vacuuming:...
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