Freezing-drying powder injectiong contg. Xi-Duo-Fu-Wei

A technology for freeze-dried powder injection and injection, applied in the field of medicine, can solve problems such as single dosage form, and achieve the effects of facilitating storage and transportation, improving stability and ensuring quality

Inactive Publication Date: 2005-01-05
肖广常 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the dosage form of this drug is relatively sing

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Embodiment 1: cidofovir freeze-dried powder for injection, the components are as follows, all in percentage by weight:

[0019] Cidofovir 78.947%

[0020] Mannitol 21.053%

[0021] The preparation method is as follows:

[0022] Weigh 375g of cidofovir and add 2.4L of water for injection, stir to dissolve, add 100g of mannitol, stir to dissolve, adjust the pH value to 7.4, add water for injection to 3L, and stir well. Add 0.02% charcoal for needles, stir at room temperature for 30 minutes, filter and decarbonize with a titanium filter stick, filter through a double-layer 0.22μm microporous sterile filter, divide the filtrate into 3ml each, and put it in a vacuum freeze dryer , lower the temperature to -40°C, freeze for 5 hours, turn on the vacuum pump, turn off the vacuum freeze dryer, naturally raise the temperature to 20°C, continue vacuuming for 12 hours, control the temperature of the partition to rise to 50°C, continue vacuuming for 9 hours, press the plug out Bo...

Embodiment 2

[0023] Embodiment 2: cidofovir freeze-dried powder for injection, the components are as follows, all in percentage by weight:

[0024] Cidofovir 100%

[0025] The preparation method is as follows:

[0026] Weigh 375 g of cidofovir and add 2.4 L of water for injection, stir to dissolve, adjust the pH value to 7.0, add water for injection to 3 L, and stir well. Add 0.02% charcoal for needles, stir at room temperature for 30 minutes, filter and decarbonize with a titanium filter stick, filter through a double-layer 0.22μm microporous sterilizing filter, divide the filtrate into 3ml per tube, press half plug, and put it in vacuum freezer In the dryer, cool down to -40°C, freeze for 4 hours, turn on the vacuum pump, turn off the vacuum freeze dryer, naturally raise the temperature to 20°C, continue vacuuming for 12 hours, control the temperature of the partition to gradually increase to 50°C, and continue vacuuming for 9 hours , pressing the plug out of the box and rolling the ca...

Embodiment 3

[0027] Embodiment 3: cidofovir freeze-dried powder for injection, the components are as follows, all in percentage by weight:

[0028] Cidofovir 27.273%

[0029] Low Molecular Dextran 72.727%

[0030] The preparation method is as follows:

[0031] Weigh 187.5 g of cidofovir, add 4 L of water for injection, stir to dissolve, adjust the pH value to 7.5, add water for injection to 5 L, and stir well. Add 0.02% charcoal for needles, stir at room temperature for 30 minutes, filter and decarbonize with a titanium filter stick, filter through a double-layer 0.22μm microporous sterilizing filter, divide the filtrate into 5ml per tube, press half the stopper, and put it into vacuum freezing In the dryer, cool down to -45°C, freeze for 6 hours, turn on the vacuum pump, turn off the vacuum freeze dryer, naturally raise the temperature to 20°C, continue vacuuming for 22 hours, control the temperature of the partition to gradually increase to 50°C, and continue vacuuming for 15 hours , ...

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PUM

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Abstract

A Xiduofuwei injection in the form of freeze-dried powder for treating AIDS, cytomegalovirus infection of retina, hepes, simplex virus infection, variola virus infection, etc is prepared from Xiduofuwei, and excipient through proportional dissolving, regulating pH value, filter, quickly freezing, heatingand sublimation drying.

Description

(1) Technical field [0001] The invention relates to cidofovir freeze-dried powder for injection and belongs to the technical field of medicine. (2) Background technology [0002] Cytomegalovirus (CMV) is a pathogen that seriously endangers human health. People of all ages may be infected with CMV, especially newborns, organ transplant recipients, and immunocompromised persons such as HIV-infected persons and AIDS patients. After infection with CMV, it is generally asymptomatic and recessive infection. Once the immune function is impaired, it will lead to serious diseases. The clinical manifestations are fever, lethargy, leukopenia, thrombocytopenia, hepatitis, pneumonia, encephalitis, gastritis and other symptoms of systemic infection. ; 45% of AIDS patients develop acute retinitis with a high rate of blindness. The drugs used to treat CMV infection are ganciclovir and foscarnet. Ganciclovir is currently the drug of choice for the treatment of CMV infection. Due to drug re...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/7052A61P31/12A61P31/22
Inventor 肖广常张颖
Owner 肖广常
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