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Vidarabine monophosphate injection and preparation method thereof

A vidarabine monophosphate injection and the technology of vidarabine monophosphate are applied in the field of pharmaceutical inventions, which can solve the problems of unguaranteed stability and difficult quality control of preparations, and reduce potential safety hazards, ensure safety, and use convenient effect

Inactive Publication Date: 2013-07-17
GUANGDONG XIANQIANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is a patent application for water injection, the application number is: 200410021225.1. In this patent, no pH regulator or buffer solution is added to adjust the pH value of the solution. According to the easy hydrolysis of adenosine monophosphate, the stability of the preparation cannot be guaranteed. Difficult to control quality

Method used

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  • Vidarabine monophosphate injection and preparation method thereof
  • Vidarabine monophosphate injection and preparation method thereof
  • Vidarabine monophosphate injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023]

[0024] Weigh 50g of vidarabine monophosphate and 0.015g of sodium hydroxide respectively, and set aside; weigh 1.5g of activated carbon, add water for injection about 3 times the amount of activated carbon, stir and moisten, set aside; inject water for injection with a dilute dosage of 20%, Add a pH regulator, stir to dissolve, adjust the water temperature to ≤30°C, then add adenosine monophosphate, stir until completely dissolved, add water for injection to 70% of the total amount, and the pH of the liquid to 7.0-7.5; add active Carbon, heated to 80°C, stirred and adsorbed for 15 minutes; 0.22μm sterilized filter, sterilized with pure steam at 121°C, 20 minutes on-line; supplemented with water for injection to 95% of the theoretical preparation amount, took samples to measure the content, and calculated according to the content. Water for injection to 2000ml, at the same time turn on the stirring and liquid return pump circulation for not less than 10 minutes, take...

Embodiment 2

[0026]

[0027] Weigh 100g of vidarabine monophosphate and 0.018g of sodium hydroxide respectively, and set aside; weigh 1.8g of activated carbon, add water for injection about 3 times the amount of activated carbon, stir and moisten, set aside; inject water for injection with a dilute dosage of 25%, Add a pH regulator, stir to dissolve, adjust the water temperature to ≤30°C, then add adenosine monophosphate, stir until completely dissolved, add water for injection to 70% of the total amount, and the pH of the liquid to 7.0-7.5; add active Carbon, heated to 80°C, stirred and adsorbed for 15 minutes; 0.22μm sterilized filter, sterilized with pure steam at 121°C, 20 minutes on-line; supplemented with water for injection to 95% of the theoretical preparation amount, took samples to measure the content, and calculated according to the content. Water for injection to 2000ml, at the same time turn on the stirring and liquid return pump circulation for not less than 10 minutes, tak...

Embodiment 3

[0029]

[0030] Weigh 50 g of vidarabine monophosphate, 0.029 g of disodium hydrogen phosphate, and 0.001 g of sodium dihydrogen phosphate, and set aside; weigh 1.5 g of activated carbon, add water for injection about 3 times the amount of activated carbon, stir and moisten, set aside; inject dilute Dosing 30% water for injection, adding a pH regulator, stirring to dissolve, adjusting the water temperature to ≤30°C, then adding adenosine monophosphate, stirring until completely dissolved, supplementing water for injection to 70% of the total amount, and pH of the liquid medicine value to 7.0-7.5; add activated carbon, heat to 80°C, stir and adsorb for 15 minutes; sterilize and filter at 0.22μm, use pure steam at 121°C, and sterilize on-line for 20 minutes; add water for injection to 95% of the theoretical preparation amount, and take samples Measure the content, calculate and add water for injection to 2000ml according to the content, and at the same time turn on the stirrin...

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Abstract

The invention provides a vidarabine monophosphate injection and a preparation method thereof. The injection is prepared from the following raw materials by weight: 50-200 parts of vidarabine monophosphate, 0.015-0.05 part of a pH regulator and 2000 parts of water for injection. A finished product prepared by the method provided by the invention has low impurity content, good homogeneity and good stability. A water injection is subjected to terminal sterilization to ensure the safety of the product. The water injection is convenient to use, and does not need to be prepared before clinical application, so as to reduce the potential safety hazard caused by operation and provide a new choice of medication for clinical use.

Description

technical field [0001] The invention belongs to the field of medical inventions, and in particular relates to a vidarabine monophosphate injection and a preparation method thereof. Background technique [0002] Vidarabine monophosphate (Am-AMP) is a monophosphate compound of vidarabine (Ara-A), which is a synthetic adenosine antiviral drug. At present, it is mainly used for chronic viral hepatitis, herpes simplex virus, herpes zoster virus, vaccinia virus, various animal herpes viruses and a few carcinogenic RNA viruses in China. Vidarabine monophosphate has been listed in Europe, the United States, Japan and many other countries. This product is an anti-deoxyribonucleic acid (DNA) virus drug, and its pharmacological action is to combine with the deoxyribonucleic acid polymerase of the virus to reduce its activity and inhibit DNA synthesis. After adenosine monophosphate enters the cell, it undergoes phosphorylation to generate adenosine adenosine diphosphate (Ara-ADP) and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/7076A61P31/12A61P31/14A61P31/20A61P31/22
Inventor 陈超张志生孙晔杜丽丽王学文付培荣黄彩逢
Owner GUANGDONG XIANQIANG PHARMA
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