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Preparation method of ganciclovir sodium freeze-dried powder for injection

A technology of ganciclovir sodium and freeze-dried powder, which is applied in the field of medicine, can solve the problems of hygroscopicity and purity of ganciclovir or ganciclovir sodium freeze-dried powder, and achieve improved appearance and moisture absorption. Sexually low effect

Active Publication Date: 2021-10-08
HAINAN HAILING CHEMIPHARMA CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

And there is no study on hygroscopicity and purity of ganciclovir or ganciclovir sodium freeze-dried powder

Method used

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  • Preparation method of ganciclovir sodium freeze-dried powder for injection
  • Preparation method of ganciclovir sodium freeze-dried powder for injection
  • Preparation method of ganciclovir sodium freeze-dried powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A preparation method of ganciclovir sodium freeze-dried powder for injection, comprising the following steps successively:

[0026] (1) Add mannitol to water for injection to prepare a mannitol solution. The mass concentration of the mannitol solution is 5%.

[0027] (2) Add activated carbon to the mannitol solution in step (1), stir for 20 minutes, let stand for 15 minutes, and then coarsely filter and decarbonize; pass the mannitol solution after the coarse filtration and decarbonization through a 0.22 μm aseptic mixed cellulose film to prepare Purified mannitol solution was obtained. The mass concentration of the activated carbon in the mannitol solution is 0.05%. The weight ratio of the ganciclovir sodium to the mannitol solution is 0.010:1.

[0028] (3) Ganciclovir sodium is added in the purified mannitol solution, and then 0.22 μm aseptic mixed cellulose film is used to make Ganciclovir sodium solution; the Ganciclovir sodium solution temperature is controlled ...

Embodiment 2

[0032] A preparation method of ganciclovir sodium freeze-dried powder for injection, comprising the following steps successively:

[0033] (1) Add mannitol to water for injection to prepare a mannitol solution. The mass concentration of the mannitol solution is 2%.

[0034] (2) Add activated carbon to the mannitol solution in step (1), stir for 30 minutes, let stand for 20 minutes, and then coarsely filter and decarbonize; pass the mannitol solution after the coarse filtration and decarbonization through a 0.22 μm aseptic mixed cellulose film to prepare Purified mannitol solution was obtained. The mass concentration of the activated carbon in the mannitol solution is 0.1%. The weight ratio of the ganciclovir sodium to the mannitol solution is 0.020:1.

[0035] (3) Ganciclovir sodium is added in the purified mannitol solution, and then 0.22 μm aseptic mixed cellulose film is used to make Ganciclovir sodium solution; the Ganciclovir sodium solution temperature is controlled a...

Embodiment 3

[0039] A preparation method of ganciclovir sodium freeze-dried powder for injection, comprising the following steps successively:

[0040] (1) Add mannitol to water for injection to prepare a mannitol solution. The mass concentration of the mannitol solution is 4%.

[0041] (2) Add activated carbon to the mannitol solution in step (1), stir for 25 minutes, let stand for 18 minutes, and then coarsely filter and decarbonize; pass the mannitol solution after the coarse filtration and decarbonization through a 0.22 μm aseptic mixed cellulose film to prepare Purified mannitol solution was obtained. The mass concentration of the activated carbon in the mannitol solution is 0.07%. The weight ratio of the ganciclovir sodium to the mannitol solution is 0.015:1.

[0042] (3) Ganciclovir sodium is added in the purified mannitol solution, and then the 0.22 μm aseptic mixed cellulose film is used to make the Ganciclovir sodium solution; the temperature of the Ganciclovir sodium solution...

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Abstract

The invention discloses a preparation method of ganciclovir sodium freeze-dried powder for injection, which sequentially comprises the following steps: adding mannitol into water for injection, then adding activated carbon, stirring and standing, and then performing coarse filtering and decarburization; enabling the mannitol solution subjected to rough filtration and decarburization to pass through a sterile mixed cellulose film to prepare a purified mannitol solution; adding ganciclovir sodium into the purified mannitol solution, and then preparing a ganciclovir sodium solution through the sterile mixed cellulose film; carrying out temperature control on the ganciclovir sodium solution, and regulating a pH value with CO2; filling a bottle with the ganciclovir sodium solution, and carrying out freeze-drying after semi-plug pressing; and after the freeze-drying is finished, performing plug pressing and re-pressing to prepare the ganciclovir sodium freeze-dried powder for injection. As a protective agent of the ganciclovir sodium freeze-dried powder, the mannitol is more suitable for storage of the ganciclovir sodium freeze-dried powder, and the purity of the ganciclovir sodium freeze-dried powder can be better guaranteed.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a preparation method of ganciclovir sodium freeze-dried powder for injection. Background technique [0002] Ganciclovir sodium, also known as 9-(1,3-dihydroxy-2-propoxymethyl)-guanine sodium, the molecular formula is C 9 h 12 N 5 NaO 4 , prepared from ganciclovir. Compared with ganciclovir, ganciclovir sodium has better water solubility. At present, the research on ganciclovir sodium mainly focuses on the crystallization of ganciclovir sodium. [0003] [0004] CN01133524.6 discloses ganciclovir sodium hydrate and its preparation method and application. It is believed that the sample moisture absorption rate and impurities prepared by this method are far lower than those prepared by the freeze-drying method. In order to solve the problem of ganciclovir sodium freeze-drying , This application focuses on the lyophilized powder of ganciclovir sodium for injection, so as to provide a...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/522A61K47/26
CPCA61K9/19A61K9/0019A61K31/522A61K47/26
Inventor 路国荣陆一峰蔡亲
Owner HAINAN HAILING CHEMIPHARMA CORP
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