Method for preparing vidarabine monophosphate for injection

A technology for adenosine vidarabine monophosphate and injections, which is applied to medical preparations containing no active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, and can solve the problems of reduced safety, large differences in the stability of aqueous solutions, and Safety hazards and other issues, to achieve the effect of simple production process

Active Publication Date: 2010-12-29
GUANGDONG XIANQIANG PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing Chinese patent 200410021225.1 discloses a preparation method for water injection. Due to its own characteristics, nucleoside drugs need to add many different types of auxiliary materials in the process of preparing water injection to ensure th...

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Vidarabine monophosphate 100g

[0015] Mannitol 40g

[0016] 5% sodium hydroxide solution appropriate amount

[0017] Add water for injection to 2000ml

[0018]

[0019] Made 1000 pieces

[0020] Preparation method: Take 100g of vidarabine monophosphate, 40g of mannitol, add 1500ml of water for injection to dissolve, adjust the pH to 7, make up water for injection to 2000ml, fill, put the filled product in a freeze-drying box, and pre-freeze at -50°C After 2 hours, vacuum the inside of the box to 25Pa, slowly raise the temperature at 2°C / hour for sublimation until the product temperature reaches -5°C, further raise the temperature for desorption and drying, equilibrate at 40°C for 1 hour, and press the plug completely. Capping, light inspection, labeling and packaging of freeze-dried products.

Embodiment 2

[0022] Adenosine Vidarabine Monophosphate 200g

[0023] Mannitol 50g

[0024] 5% sodium hydroxide solution appropriate amount

[0025] Add water for injection to 2500ml

[0026]

[0027] Made 1000 pieces

[0028] Preparation method: Take 200 g of vidarabine monophosphate, 50 g of mannitol, add 2000 ml of water for injection to dissolve, adjust the pH to 7, make up the water for injection to 2500 ml, fill it, put it into a freeze dryer and freeze dry as in Example 1.

Embodiment 3

[0030] Vidarabine monophosphate 100g

[0031] Hydrolyzed Gelatin 70g

[0032] 5% sodium hydroxide solution appropriate amount

[0033] Add water for injection to 2000ml

[0034]

[0035] Made 1000 pieces

[0036] Preparation method: take 200 g of vidarabine monophosphate, add 70 g of hydrolyzed gelatin into 1500 ml of water for injection to dissolve, adjust pH to 7, make up water for injection to 2500 ml, fill, put into a freeze dryer and freeze dry as in Example 1.

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PUM

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Abstract

The invention discloses a method for preparing vidarabine monophosphate for injection, which comprises the following steps of: dissolving vidarabine monophosphate into a solvent with heating, adding a proper amount of excipient and active carbon into the solution, filtering the solution to remove carbon, filtering the solution through a micropore filtration membrane, canning the filtrate into a tubular furbenicillin bottle, and putting the furbenicillin bottle into a freeze drier to perform freeze drying. The method is easy for industrialized production, solves the problem of vidarabine monophosphate freeze drying preparation, and ensures stable product quality.

Description

technical field [0001] The invention relates to a preparation method of a pharmaceutical preparation, more specifically, to a preparation method of vidarabine monophosphate for injection. technical background [0002] VidarabineMonophosphate Ara-AMP is an adenosine antiviral drug, which is an anti-deoxyribonucleic acid (DNA) virus drug, and is a high Selective, safe and effective antiviral drugs. The monophosphate compound Ara-AMP is highly water-soluble, more than 400 times larger than Ara-A, and can be used for long-term intramuscular injection in addition to intravenous infusion. Similar to other antiviral drugs, Ara-AMP cannot kill and remove infected viruses, but its high efficiency can quickly inhibit the proliferation of DNA viruses and control symptoms. Its pharmacological mechanism 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 phosp...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/7076A61K47/10A61K47/20A61K47/32A61K47/42A61P31/14A61P31/20A61P31/22
Inventor 沈小钟张志生邱亚平王玉生张现涛
Owner GUANGDONG XIANQIANG PHARMA
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