Parenteral preparation containing active entecavir and preparation method thereof

A technology of entecavir and active ingredients, which is applied in the field of preparations administered by injection and its preparation, and can solve problems such as prone to medical disputes

Inactive Publication Date: 2010-06-30
TIANJIN PACIFIC PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, it is known that diabetic patients have acute complications, urgently need to supplement energy and infusion medication, and when infusion of glucose solution is not suitable, medical disputes are prone to occur

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Take 3g of entecavir and 0.3g of xylitol, put them in a container, add 0.1g of polyvinylpyrrolidone as a solubilizing agent, 80ml of water for injection, add 0.2g of sodium hydroxide, stir to dissolve, add 1mol / L of citric acid to adjust the pH to 7-9.0, add 28g of mannitol, stir to dissolve, add water to 100ml. Add 0.5g of activated carbon, stir at 30°C for 20 minutes, decarburize, filter and sterilize with a microporous membrane, divide the filtrate into 1ml tubes, pre-freeze for 2 hours, and dry under reduced pressure for 12 hours until After the temperature of the sample reached room temperature, it was dried for another 5 hours to obtain a white loose block, which was sealed to obtain the entecavir freeze-dried powder injection.

Embodiment 2

[0030]Take 50g of entecavir and 3g of xylitol, put them in a container, add 2g of PEG-6000, 180ml of water for injection, stir to dissolve, adjust the pH to 5.0-9.0 with 1mol / L hydrochloric acid or sodium hydroxide, add 80g of mannitol, Sorbitol 20g, stir to dissolve, add water to 2000ml. Add 0.5g of activated carbon, stir at 30°C for 20 minutes, decarburize, filter and sterilize with a microporous membrane, divide the filtrate into 2ml tubes, pre-freeze for 2 hours, and dry under reduced pressure for 18 hours until After the temperature of the sample reached room temperature, it was dried for another 5 hours to obtain a white loose block, which was sealed to obtain the entecavir freeze-dried powder injection.

Embodiment 3

[0032] Take 10g of entecavir and 0.3g of xylitol, add it to 440ml of water for injection in which 5g of sodium lauryl sulfate has been dissolved, add 2g of sodium thiosulfate and stir to dissolve, add sodium bicarbonate to adjust the pH to 5.5-8.5, add 0.5g Activated carbon, stirred and adsorbed at room temperature for 30 minutes, decarbonized, added water to 500ml, finely filtered, filled with 5ml each, and sterilized to obtain Entecavir injection.

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PUM

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Abstract

The invention relates to a parenteral preparation containing active entecavir and a preparation method thereof. The invention is characterized in that the parenteral preparation comprises the active entecavir, xylitol, water-soluble filler, pH regulator, water for injection and osmo-regulator, wherein the active entecavir is 0.001 percent to 30 percent by weight, and the balance is pharmaceutic adjuvant or water. The parenteral preparation has the advantages of good stability and high bioavailability, thus solving the defects of the oral administration of entecavir in treating the acute exacerbation of viruses. The parenteral preparation is particularly suitable for treatment on the acute exacerbation of hepatitis of a diabetic.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and more specifically relates to an injection-administered preparation containing active ingredients entecavir and xylitol and a preparation method thereof. Background technique [0002] Hepatitis B is a worldwide disease caused by the hepatitis B virus. The incidence rate is high in developing countries. According to statistics, there are more than 280 million asymptomatic carriers (HBsAg carriers) in the world, and my country accounts for more than 100 million. Most of them are asymptomatic, and 1 / 3 of them have clinical manifestations of liver damage. It is characterized by slow onset, and subclinical and chronic types are more common. Anicteric HBsAg persistently positive patients tend to become chronic. The disease is mainly transmitted through blood and close contact in daily life, and another way is mother-to-child transmission. The application of hepatitis B vaccine is the f...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/513A61P1/16A61P31/12
Inventor 宋德成
Owner TIANJIN PACIFIC PHARMA
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