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Ganciclovir powder-injection for injection

A technology of ganciclovir and water for injection, which is applied in the field of pharmaceutical preparations and can solve the problems of poor anti-CMV effect, excessive taking times, and compliance problems of HIV patients

Active Publication Date: 2015-04-29
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

39 mg,

Sodium chloride

l5mg,

1-Deoxy-1-(methylamino)-D-sorbitol

l5mg,

pH regulator

to pH11.0,

Water for Injection

Appropriate amount, add to 2ml.

[0111] Preparation:

[0112] (1) Weigh the main drug and auxiliary materials (except sodium hydroxide and pH regulator) of the prescribed amount, place them in a stainless steel bucket, add about 80% of the prescribed amount of water for injection, stir to disperse, and add the prescribed amount of sodium hydroxide , continue to stir to dissolve each component, 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 ...

preparation example 2

[0118] Supplementary Preparation Example 2: Referring to the method of Preparation Example 1 above, the difference is 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 obtained powder injection numbers are respectively Ex121, Ex122, Ex123, Ex124, Ex125, Ex126, Ex127, Ex128, Ex129, Ex130, Ex131, Ex132.

preparation example 3

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

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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 for the prevention and treatment of life-threatening or vision-threatening immunodeficiency patients infected by cytomegalovirus, as well as the prevention of organ transplantation patients related to cytomegalovirus infection, especially The invention relates to a ganciclovir powder injection for injection, and the powder injection has good pharmaceutical properties. Background technique [0002] The ganciclovir involved in the present invention is an effective antiviral drug, which is usually clinically used to prevent and treat life-threatening or vision-threatening immunodeficiency patients infected by cytomegalovirus, and to prevent of organ transplant patients. The chemical name of ganciclovir is: 9-[[2-hydroxyl-1-(hydroxymethyl)ethoxy]methyl]guanine, and the chemical structural formula is: [0003] [0004...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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