A kind of 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: 2022-06-28
HAINAN HAILING CHEMIPHARMA CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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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  • A kind of preparation method of ganciclovir sodium freeze-dried powder for injection
  • A kind of preparation method of ganciclovir sodium freeze-dried powder for injection
  • A kind of 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 in turn:

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

[0027] (2) adding activated carbon to the mannitol solution of step (1), stirring for 20min, standing for 15min, and then coarsely filtering and decarbonizing; passing the mannitol solution after coarsely filtering and decarbonizing through a 0.22 μm sterile mixed cellulose film to prepare A 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) adding ganciclovir sodium to the purified mannitol solution, and then passing a 0.22 μm sterile mixed cellulose film to prepare a ganciclovir sodium solution; the temperature of the ganciclovir sodium solution is contr...

Embodiment 2

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

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

[0034] (2) adding activated carbon to the mannitol solution of step (1), stirring for 30min, standing for 20min, and then coarsely filtering and decarbonizing; passing the mannitol solution after coarsely filtering and decarbonizing through a 0.22 μm sterile mixed cellulose film to prepare A 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) adding ganciclovir sodium to the purified mannitol solution, and then passing a 0.22 μm sterile mixed cellulose film to prepare a ganciclovir sodium solution; the temperature of the ganciclovir sodium solution is contro...

Embodiment 3

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

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

[0041] (2) adding activated carbon to the mannitol solution in step (1), stirring for 25 minutes, leaving it to stand for 18 minutes, and then coarsely filtering and decarbonizing; passing the mannitol solution after coarse filtering and decarbonizing through a 0.22 μm sterile mixed cellulose film to prepare A 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) adding ganciclovir sodium to the purified mannitol solution, and then passing a 0.22 μm sterile mixed cellulose film to prepare a ganciclovir sodium solution; the temperature of the ganciclovir sodiu...

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Abstract

The invention discloses a preparation method of ganciclovir sodium freeze-dried powder for injection, which comprises the following steps in sequence: adding mannitol into water for injection, adding activated carbon, stirring and standing still, and then decarbonizing by coarse filtration; The decarbonized mannitol solution is passed through a sterile mixed cellulose film to obtain a purified mannitol solution; adding ganciclovir sodium to the purified mannitol solution, and then passed through a sterile mixed cellulose film to obtain Ganciclovir sodium solution; Described Ganciclovir sodium solution is carried out temperature control, and with CO 2 Adjusting the pH value; putting the ganciclovir sodium solution in a bottle, half-tamping and then freeze-drying; after the freeze-drying is finished, pressing and re-pressing to obtain the ganciclovir sodium freeze-dried powder for injection. The mannitol of the present invention is more suitable for the storage of the ganciclovir sodium freeze-dried powder as the protective agent of the ganciclovir sodium freeze-dried powder, and can better ensure the purity of the ganciclovir sodium freeze-dried powder.

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 moisture absorption rate and impurities of the samples prepared by this method are far lower than the samples prepared by the freeze-drying method. In order to solve the problem of freeze-drying of ganciclovir sodium , This application focuses on ganciclovir sodium lyophilized powder to provide a low moistu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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