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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[0024] Example 1
[0025] A method for freeze-drying ganciclovir, including the following steps:
[0026] S1. Add the excipient dextran or mannitol to an appropriate amount of water for injection, heat to completely dissolved, and filter;
[0027] S2. Add cooled water for injection to the filtrate to 70% of the prescription amount in the process, and then slowly add the prescription amount of ganciclovir while stirring to dissolve;
[0028] S3. Use sodium hydroxide to adjust the pH to 12.0, then add water for injection to the prescription amount;
[0029] S4. Sterilize through a 0.22μm cartridge filter and filter the liquid medicine;
[0030] S5. Under the A-level laminar flow, fill the sterilized and filtered liquid medicine into the processed bottle according to the dosage of each bottle, and then semi-stopper;
[0031] S6. Put the filled liquid medicine into the freeze-drying box.
[0032] S7. Turn on the freeze-drying machine and perform freeze-drying. The freeze-drying procedure is as...
Example Embodiment
[0038] Example 2
[0039] A method for freeze-drying ganciclovir, including the following steps:
[0040] S1. Add the excipient dextran or mannitol to an appropriate amount of water for injection, heat to completely dissolved, and filter;
[0041] S2. Add cooled water for injection to the filtrate to 60% of the prescription amount in the process, and then slowly add the prescription amount of ganciclovir while stirring to dissolve;
[0042] S3. Use sodium hydroxide to adjust the pH to 11.0, then add water for injection to the prescription amount;
[0043] S4. Sterilize through a 0.22μm cartridge filter and filter the liquid medicine;
[0044] S5. Under the A-level laminar flow, fill the sterilized and filtered liquid medicine into the processed bottle according to the dosage of each bottle, and then semi-stopper;
[0045] S6. Put the filled liquid medicine into the freeze-drying box.
[0046] S7. Turn on the freeze-drying machine and perform freeze-drying. The freeze-drying procedure is as...
Example Embodiment
[0052] Example 3
[0053] A method for freeze-drying ganciclovir, including the following steps:
[0054] S1. Add the excipient dextran or mannitol to an appropriate amount of water for injection, heat to completely dissolved, and filter;
[0055] S2. Add cooled water for injection to the filtrate to 80% of the prescription amount in the process, and then slowly add the prescription amount of ganciclovir while stirring to dissolve;
[0056] S3. Use sodium hydroxide to adjust the pH to 13.0, and then add water for injection to the prescription amount;
[0057] S4. Sterilize through a 0.22μm cartridge filter and filter the liquid medicine;
[0058] S5. Under the A-level laminar flow, fill the sterilized and filtered liquid medicine into the processed bottle according to the dosage of each bottle, and then semi-stopper;
[0059] S6. Put the filled liquid medicine into the freeze-drying box.
[0060] S7. Turn on the freeze-drying machine and perform freeze-drying. The freeze-drying procedure i...
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