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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

Inactive Publication Date: 2019-12-27
WUXI KAIFU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The freeze-dried ganciclovir obtained through this patent is prone to shrinkage, which affects the quality and yield of the product

Method used

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Examples

Experimental program
Comparison scheme
Effect test

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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PUM

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Abstract

The invention discloses a freeze-drying method of ganciclovir. The condensation temperature is set as -30 to -20 DEG C in advance during freeze-drying, the vacuum degree is controlled as 0.1-0.3 mbar,the operation time is 2000-2200 min, then the temperature is set as 30-40 DEG C, the vacuum degree is controlled as 0.1-0.3 mbar, and the operation time is 100-300 min; and then heat preservation isconducted for 60-120 min at 30-40 DEG C. According to the freeze-drying method, a constant temperature gradient is adopted to conduct freeze drying in each freeze-drying stage, thus the number and size of crystal nucleus of a product solution reach the most appropriate degree, the phenomenon of product shrinkage is greatly reduced, the dried product is more loose and porous, and dissolving is easier after water is added.

Description

technical field [0001] The invention relates to a freeze-drying method for preparing ganciclovir. Background technique [0002] The ganciclovir composition comprises: ganciclovir and sodium hydroxide are formed into salt, and dextran or mannitol is added as an auxiliary material. Ganciclovir for injection is mainly used to prevent and treat life-threatening or vision-threatening immunodeficiency patients infected by cytomegalovirus, and to prevent organ transplant patients related to cytomegalovirus infection. Freeze-dried preparations are drugs that remove water from substances in a low-temperature, vacuum environment. Therefore, the production process of lyophilized preparations is generally carried out in three steps, namely pre-freezing, sublimation drying (or called first-stage drying), and analytical drying (or called second-stage drying). The dried product is loose and porous, in the form of a sponge, and dissolves quickly and completely after adding water. In addi...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/522A61K47/26A61P31/12F26B5/06
CPCA61K9/0019A61K9/19A61K31/522A61K47/26A61P31/12F26B5/06
Inventor 刘骞
Owner WUXI KAIFU PHARMA
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