Freeze-drying method for preparing ganciclovir
A ganciclovir and freeze-drying technology, which is applied in the field of freeze-drying for preparing ganciclovir, can solve the problems that freeze-dried ganciclovir is prone to shrinkage, affects product quality and yield, and achieves easy dissolution and reduced atrophy effect
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Embodiment 1
[0025] A kind of lyophilization method of ganciclovir, comprises the following steps:
[0026] S1. Add the excipient dextran or mannitol into an appropriate amount of water for injection, heat until completely dissolved, and filter;
[0027] S2, add cooling water for injection in the filtrate to 70% of the prescription amount in the process, then slowly add the ganciclovir of the prescription amount while stirring to dissolve;
[0028] S3, using sodium hydroxide to adjust the pH value to 12.0, and adding water for injection to the prescribed amount;
[0029] S4. Sterilize the medicinal solution through a 0.22 μm cartridge filter;
[0030] S5. Under A-level laminar flow, the sterilized and filtered medicinal solution is filled in the treated bottle according to the dose of each bottle for half stoppering;
[0031] S6. Put the filled medicinal solution into a freeze-drying box.
[0032] S7, open freeze-drying machine, carry out freeze-drying, freeze-drying program is as follo...
Embodiment 2
[0039] A kind of lyophilization method of ganciclovir, comprises the following steps:
[0040] S1. Add the excipient dextran or mannitol into an appropriate amount of water for injection, heat until completely dissolved, and filter;
[0041] S2, add cooled water for injection to the filtrate to 60% of the prescription amount in the process, then slowly add the ganciclovir of the prescription amount while stirring to dissolve;
[0042] S3, using sodium hydroxide to adjust the pH value to 11.0, and adding water for injection to the prescribed amount;
[0043] S4. Sterilize the medicinal solution through a 0.22 μm cartridge filter;
[0044] S5. Under A-level laminar flow, the sterilized and filtered medicinal solution is filled in the treated bottle according to the dose of each bottle for half stoppering;
[0045] S6. Put the filled medicinal solution into a freeze-drying box.
[0046] S7, open freeze-drying machine, carry out freeze-drying, freeze-drying program is as follow...
Embodiment 3
[0053] A kind of lyophilization method of ganciclovir, comprises the following steps:
[0054] S1. Add the excipient dextran or mannitol into an appropriate amount of water for injection, heat until completely dissolved, and filter;
[0055] S2, add cooled water for injection to the filtrate to 80% of the prescription amount in the process, then slowly add the ganciclovir of the prescription amount while stirring to dissolve;
[0056] S3, using sodium hydroxide to adjust the pH value to 13.0, and adding water for injection to the prescription amount;
[0057] S4. Sterilize the medicinal solution through a 0.22 μm cartridge filter;
[0058] S5. Under A-level laminar flow, the sterilized and filtered medicinal solution is filled in the treated bottle according to the dose of each bottle for half stoppering;
[0059] S6. Put the filled medicinal solution into a freeze-drying box.
[0060] S7, open freeze-drying machine, carry out freeze-drying, freeze-drying program is as foll...
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