A kind of ganciclovir composition for injection and preparation method thereof

A technology of ganciclovir and composition, applied in the field of ganciclovir composition for injection and its preparation, can solve the problems of no improvement and the like, and achieve the effects of good safety, uniform and stable quality, and thorough moisture drying

Active Publication Date: 2011-12-14
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0026] None of the existing known technologi

Method used

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  • A kind of ganciclovir composition for injection and preparation method thereof
  • A kind of ganciclovir composition for injection and preparation method thereof
  • A kind of ganciclovir composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0087] prescription:

[0088] Ganciclovir 2.5Kg

[0089] Sodium hydroxide 368g

[0090] Add water for injection to 25Kg

[0091] Preparation: Weigh ganciclovir and sodium hydroxide, put them in a preparation tank, add water for injection, stir to dissolve completely and mix evenly;

[0092] Sterile filtration and sub-packaging: filter the medicinal solution into a sterile room with a 0.22 μm microporous filter, sub-package into vials at a volume of 2.5ml / bottle, and half-stopper;

[0093] Vacuum Freeze Drying:

[0094] a. Pre-freezing: Put the subpackaged ganciclovir liquid into the freeze dryer to quickly reduce the temperature of the product. When the temperature of the product is lower than -45°C, continue to freeze for 60 minutes to completely freeze the ganciclovir liquid ;

[0095] b. Cooling of the rear box: use the compressor to cool the cold trap of the rear box, so that the temperature of the cold trap of the rear box is lower than -70°C;

[0096] c. Vacuuming:...

Embodiment 2

[0101] prescription:

[0102] Ganciclovir 2.5Kg

[0103] Sodium hydroxide 357g

[0104] Add water for injection to 25Kg

[0105] Preparation: Weigh ganciclovir and sodium hydroxide, put them in a preparation tank, add water for injection, stir to dissolve completely and mix evenly;

[0106] Sterile filtration and sub-packaging: filter the medicinal solution into a sterile room with a 0.22 μm microporous filter, sub-package into vials at a volume of 2.5ml / bottle, and half-stopper;

[0107] Vacuum Freeze Drying:

[0108] a. Pre-freezing: Put the subpackaged ganciclovir liquid into the freeze dryer to quickly reduce the temperature of the product. When the temperature of the product is lower than -45°C, continue to freeze for 60 minutes to completely freeze the ganciclovir liquid ;

[0109] b. Cooling of the rear box: use the compressor to cool the cold trap of the rear box, so that the temperature of the cold trap of the rear box is lower than -70°C;

[0110] c. Vacuuming:...

Embodiment 3

[0115] prescription:

[0116] Ganciclovir 2.5Kg

[0117] Sodium hydroxide 379g

[0118] Add water for injection to 25Kg

[0119] Preparation: Weigh ganciclovir and sodium hydroxide, put them in a preparation tank, add water for injection, stir to dissolve completely and mix evenly;

[0120] Sterile filtration and sub-packaging: filter the medicinal solution into a sterile room with a 0.22 μm microporous filter, sub-package into vials at a volume of 2.5ml / bottle, and half-stopper;

[0121] Vacuum Freeze Drying:

[0122] a. Pre-freezing: Put the subpackaged ganciclovir liquid into the freeze dryer to quickly reduce the temperature of the product. When the temperature of the product is lower than -45°C, continue to freeze for 60 minutes to completely freeze the ganciclovir liquid ;

[0123] b. Cooling of the rear box: use the compressor to cool the cold trap of the rear box, so that the temperature of the cold trap of the rear box is lower than -70°C;

[0124] c. Vacuuming:...

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Abstract

The invention relates to a ganciclovir composition for injection, which is freeze-dried powder composed of ganciclovir and sodium hydroxide, wherein the weight ratio of the ganciclovir to the sodium hydroxide is (6.6-7.0):1, the average particle size of the freeze-dried powder is 80-100nm, and the porosity is 94-98%. The preparation method comprises the following steps: 1) preparation: weighing ganciclovir and sodium hydroxide, putting the ganciclovir and sodium hydroxide into a preparation tank, adding water for injection, and stirring until the ganciclovir and sodium hydroxide are completely dissolved and evenly mixed; 2) sterile filtration and packaging; and 3) vacuum freeze drying. The invention has the advantages of simple formula, advanced technique, uniform quality and high stability, and has higher redissolution performance and clinical application safety.

Description

technical field [0001] The present invention relates to a ganciclovir composition for injection and a preparation method thereof, and the ganciclovir composition for injection prepared by the method is used for treating giant cell retinitis and bone marrow or organ transplantation with immunodeficiency The receptor protects against CMV infection. Background technique [0002] The chemical name of Ganciclovir is 9-(1,3-dihydroxy-2-propoxymethyl)-guanine. [0003] Its structural formula is: [0004] [0005] Molecular formula: C 9 h 13 N 5 o 4 [0006] Molecular weight: 255.23 [0007] Cytomegalovirus (CMV) is a double-helical DNA virus of the genus Herpesvirus β, which can cause a variety of different infectious syndromes: CMV syndrome in newborns; mononucleosis in normal healthy people; In immunocompromised patients, such as immature newborns, organ transplant recipients or AIDS (AIDS) patients, CMV can cause severe disease syndrome. It can invade all tissues and...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/522A61K47/02A61P31/12
Inventor 戴建国叶东王孝雯
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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