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Ganciclovir powder-injection for injection

A technology of ganciclovir and water for injection, applied in the field of pharmaceutical preparations, can solve the problems of poor anti-cytomegalovirus effect, excessive doses, compliance problems of HIV patients, etc.

Active Publication Date: 2013-10-09
CHENGDU TIANTAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the disadvantage of acyclovir is that it may cause compliance problems in HIV patients who have been given combination therapy; in clinical treatment, acyclovir has poor anti-CMV effect, and can cause glomerulus in large doses. block
The biggest disadvantage is that the number of daily doses exceeds the regular dose

Method used

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  • Ganciclovir powder-injection for injection
  • Ganciclovir powder-injection for injection
  • Ganciclovir powder-injection for injection

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0108] Preparation example 1. Preparation of powder injection containing ganciclovir

[0109] formula:

[0110] Ganciclovir

250mg,

Sodium hydroxide

39mg,

Sodium chloride

l5mg,

1-deoxy-1-(methylamino)-D-sorbitol

l5mg,

pH regulator

To pH11.0,

Water for Injection

Add an appropriate amount to 2ml.

[0111] Preparation:

[0112] (1) Weigh the prescription amount of the main medicine and auxiliary materials (except sodium hydroxide and pH adjuster), place them in a stainless steel barrel, add about 80% of the prescription amount of water for injection, stir to disperse, and add the prescription amount of sodium hydroxide , Continue to stir to dissolve the components, then add 0.1% (w / v) activated carbon according to the volume of the solution, stir for 30 minutes, filter and decarbonize, and add water for injection to nearly the full amount of the prescription.

[0113] (2) Take a sample of the filtrate, measure the pH value, and adjust to the specified value with a ...

preparation example 2

[0118] Supplementary Preparation Example 2: Refer to the method of Preparation Example 1, except that the amount of 1-deoxy-1-(methylamino)-D-sorbitol is adjusted to 0mg, 2mg, 5mg, 7.5mg, 10mg, 12.5mg, 17.5mg, 20mg, 22.5mg, 25mg, 30mg, 50mg, the powder injection numbers obtained are Ex121, Ex122, Ex123, Ex124, Ex125, Ex126, Ex127, Ex128, Ex129, Ex130, Ex131, Ex132, respectively.

preparation example 3

[0119] Supplementary Preparation Example 3: Refer to the method of Preparation Example 1, except that the amount of 1-deoxy-1-(methylamino)-D-sorbitol is 10mg, and the amount of sodium chloride is 0mg, 5mg, 10mg, 15mg, 20mg, 25mg, or 50mg, the powder injection numbers obtained are Ex141, Ex142, Ex143, Ex144, Ex145, Ex146, Ex147 respectively.

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PUM

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Abstract

The invention relates to ganciclovir powder-injection for injection, and particularly relates to a medicine composition. The ganciclovir powder-injection comprises ganciclovir, sodium hydroxide, sodium chloride and an optional acidifying or alkalizing agent. The medicine composition serving as an excellent antivirus drug can be used for preventing and treating life or vision-threatening immunodeficiency patients infected with cytomegalovirus and cytomegalovirus infection-related organ grafting patients. The medicine composition has excellent pharmacy property.

Description

Technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to an excellent antiviral drug that can be used to prevent and treat life-threatening or vision-threatening immunodeficiency patients infected by cytomegalovirus, and prevent organ transplant patients related to cytomegalovirus infection, especially It relates to a ganciclovir powder injection for injection, which has good pharmaceutical properties. Background technique [0002] The ganciclovir involved in the present invention is an effective antiviral drug, which is usually used clinically to prevent and treat life-threatening or vision-threatening immunodeficiency patients infected with cytomegalovirus, and to prevent cytomegalovirus infections. Of organ transplant patients. The chemical name of ganciclovir is: 9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]guanine, and the chemical structure is: [0003] [0004] Molecular formula: C9H13N5O4, molecular weight: 255.21 ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/522A61P31/20
Inventor 赵东明贾红军余茹张莲莲董国明
Owner CHENGDU TIANTAISHAN PHARMA
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