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Pharmaceutical composition containing ganciclovir compound, and preparation method thereof

A technology of ganciclovir and its composition, which is applied in the field of antiviral drug preparations, can solve the problems of reduced dissolution rate of ganciclovir and failure to meet the requirements of ganciclovir injection, etc.

Inactive Publication Date: 2011-10-12
罗诚
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this invention, the dissolution rate of ganciclovir is reduced, which cannot meet the injection requirements of ganciclovir

Method used

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  • Pharmaceutical composition containing ganciclovir compound, and preparation method thereof
  • Pharmaceutical composition containing ganciclovir compound, and preparation method thereof
  • Pharmaceutical composition containing ganciclovir compound, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] 1. Formula (weight: mg): Ganciclovir 250, Dextran 50, Sodium Hydroxide 6.5 and Polysorbate 80 60.

[0042] 2. Preparation method:

[0043] 1) Add the prescribed amount of lactose and dextran into an appropriate amount of water for injection, and stir until completely dissolved to obtain solution 1);

[0044] 2) Dissolve sodium hydroxide in an appropriate amount of water for injection, add ganciclovir and stir, and control the pH value to 10.5 to obtain solution 2);

[0045] 3) Combine solutions 1) and 2), add activated carbon with a prepared volume of 0.5%, boil for 30 minutes, filter and decarbonize, add water for injection to the full amount, and then filter to the storage tank through a sterilizing filter. After the semi-finished product passes the inspection , to be filled;

[0046] 4) The semi-finished medicinal liquid is divided into 10ml control bottles according to 5ml per bottle, and the control bottles are placed on the product room plate of the freeze dryer...

Embodiment 2

[0048] 1. Formula (weight: mg): Ganciclovir 250, Dextran 50, Sodium Hydroxide 6.5 and Polysorbate 80 80.

[0049] 2. Preparation method:

[0050] 1) Add the prescribed amount of lactose and dextran into an appropriate amount of water for injection, and stir until completely dissolved to obtain solution 1);

[0051] 2) Dissolve sodium hydroxide in an appropriate amount of water for injection, add ganciclovir and stir, and control the pH value to 11.5 to obtain solution 2);

[0052] 3) Combine solutions 1) and 2), add activated carbon with a prepared volume of 0.5%, boil for 30 minutes, filter and decarbonize, add water for injection to the full amount, and then filter to the storage tank through a sterilizing filter. After the semi-finished product passes the inspection , to be filled;

[0053] 4) The semi-finished medicinal liquid is divided into 10ml control bottles according to 5ml per bottle, and the control bottles are placed on the product room plate of the freeze dryer...

Embodiment 3

[0055] 1. Formula (weight: mg): Ganciclovir 250, Dextran 50, Sodium Hydroxide 6.5 and Polysorbate 80 70.

[0056] 2. Preparation method:

[0057] 1) Add the prescribed amount of lactose and dextran into an appropriate amount of water for injection, and stir until completely dissolved to obtain solution 1);

[0058] 2) Dissolve sodium hydroxide in an appropriate amount of water for injection, add ganciclovir and stir, and control the pH value to 11.5 to obtain solution 2);

[0059] 3) Combine solutions 1) and 2), add activated carbon with a prepared volume of 0.5%, boil for 30 minutes, filter and decarbonize, add water for injection to the full amount, and then filter to the storage tank through a sterilizing filter. After the semi-finished product passes the inspection , to be filled;

[0060] 4) The semi-finished medicinal liquid is divided into 10ml control bottles according to 5ml per bottle, and the control bottles are placed on the product room plate of the freeze dryer...

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Abstract

The invention discloses a pharmaceutical composition containing a ganciclovir compound, and a preparation method thereof. The pharmaceutical composition is composed of ganciclovir, polysorbate 80, sodium hydroxide and dextran. The ganciclovir pharmaceutical composition overcomes the irritation of the existing ganciclovir lyophilized powder injections on an injection site, and improves the stability of the ganciclovir lyophilized powder injection and the compliance of patients.

Description

technical field [0001] The invention relates to a preparation of antiviral drugs, in particular to a pharmaceutical composition containing a ganciclovir compound and a preparation method thereof. Background technique [0002] Ganciclovir (ganciclovir), as shown in formula I, has a chemical name of 9-(1,3-dihydroxy-2-propoxymethyl)guanine. [0003] [0004] Formula I [0005] This product is white crystalline powder with molecular formula C 9 h 13 N 5 0 4 , with a molecular weight of 255.23, slightly soluble in water (the solubility in water at 25°C is 2.6mg / mL), almost insoluble in methanol, insoluble in dichloromethane; slightly soluble in hydrochloric acid solution or sodium hydroxide solution. The solubility of its monosodium salt in water at 25°C is 50 mg / mL. At physiological pH, ganciclovir sodium salt exists in a non-ionic form with a solubility of 6 mg / mL. [0006] Ganciclovir is an antiviral drug commonly used in clinical practice. It has broad-spectrum anti...

Claims

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Application Information

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IPC IPC(8): A61K31/522A61K9/19A61K47/02A61K47/38A61K47/34A61P31/12A61P31/22
Inventor 罗诚
Owner 罗诚
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