A kind of medicinal composition of vidarabine monophosphate for injection

A technology of adenosine vidarabine monophosphate and composition, which is applied in the direction of pharmaceutical formulations, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., and can solve the instability and impact of adenosine monophosphate hydrochloride To solve the problems of drug quality and inconvenient use, etc., to achieve the effect of excellent appearance, improving appearance shape and porosity, and preventing spray bottles

Active Publication Date: 2015-08-19
GUANGDONG LONGFU MEDICINE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, according to literature reports, vidarabine hydrochloride monophosphate is unstable in aqueous solution, and if it is placed for a long time, part of the hydrochloride will be hydrolyzed and separated, resulting in insoluble visible foreign matter, which will affect the quality of the drug and reduce the curative effect, so it is suitable to be made into a freeze-dried agent
At present, the solubility of adenosine monophosphate monophosphate for injection on the market is average. After adding water for injection, it needs to be shaken for a few minutes before it can be completely dissolved, which affects the convenience of use, and the solution is slightly cloudy, which affects the safety of use, and it is not easy to use. too convenient

Method used

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Examples

Experimental program
Comparison scheme
Effect test

specific Embodiment 1

[0062] Adenosine monophosphate 2g

[0063] Lysine 8g

[0064] Mannitol 50g

[0065] Disodium hydrogen phosphate 2g

[0066] Sodium Dihydrogen Phosphate 0.2g

[0067] A medicinal composition of adenosine monophosphate monophosphate for injection, taking adenosine monophosphate monophosphate and adding an appropriate amount of anhydrous ethanol to dissolve completely, adding water for injection, then slowly adding lysine under stirring, adding mannitol, all the Dissolve, take a pH regulator (disodium hydrogen phosphate-sodium dihydrogen phosphate) to adjust the pH of the solution within the range of 7.0, stir at room temperature, centrifuge, take the supernatant, filter it with a 0.22 μm microporous membrane, and filter the filtrate. Dispense into vials and freeze-dry.

[0068] 1000 bottles of the present invention consume 1005ml of water for injection.

[0069] Wherein, the freeze-drying process includes successively:

[0070] Pre-freeze, put the product in a freeze-d...

specific Embodiment 2

[0075] Composition of pharmaceutical composition (in 1000 bottles)

[0076] Adenosine monophosphate 2g

[0077] Water-soluble Chitosan Derivatives 10g

[0078] Lysine 2g

[0079] Mannitol 20g

[0080] Disodium hydrogen phosphate 2 g

[0081] Sodium Dihydrogen Phosphate 0.2g

[0082] A medicinal composition of adenosine monophosphate monophosphate for injection, taking adenosine monophosphate monophosphate and adding an appropriate amount of anhydrous ethanol to dissolve completely, taking a water-soluble chitosan derivative and dissolving it in water for injection, and then slowly adding lysine under stirring. Add mannitol, dissolve all of them, take a pH adjuster (disodium hydrogen phosphate-sodium dihydrogen phosphate) to adjust the pH of the solution within the range of 7.0, stir at room temperature, centrifuge, take the supernatant, use a 0.22 μm micropore After sterile filtration through the filter membrane, the filtrate was dispensed into vials, and then free...

specific Embodiment 3

[0090] Composition of pharmaceutical composition (in 1000 bottles)

[0091] Adenosine monophosphate 2g

[0092] Water-soluble Chitosan Derivatives 10g

[0093] Lysine 2g

[0094] Mannitol 20g

[0095] Disodium hydrogen phosphate 2g

[0096] Citric acid 0.2g

[0097] A medicinal composition of adenosine monophosphate monophosphate for injection, taking adenosine monophosphate monophosphate and adding an appropriate amount of anhydrous ethanol to dissolve completely, taking a water-soluble chitosan derivative and dissolving it in water for injection, and then slowly adding lysine under stirring. Acid, add mannitol, dissolve all of it, take a pH adjuster (disodium hydrogen phosphate-citric acid) to adjust the pH of the solution in the range of 7.0 to 7.5, stir at room temperature, centrifuge, take the supernatant, 0.22μm micropore After sterile filtration through the filter membrane, the filtrate was dispensed into vials, and then freeze-dried.

[0098]Adenosine monophosp...

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PUM

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Abstract

The invention relates to an officinal composition of vidarabine monophosphate for injection, wherein the main active components of the composition comprise vidarabine monophosphate and lysine.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a pharmaceutical composition of adenosine monophosphate monophosphate for injection and a preparation method thereof. Background technique [0002] Vidarabine monophosphate (Ara-AMP) is a monophosphate compound of adenosine arabinosine (Ara-A), which is a synthetic adenosine antiviral drug. It is the second-generation preparation of adenosine arabinoside, which is currently mainly used in my country for chronic viral hepatitis, herpes simplex virus, herpes zoster virus, vaccinia virus, a variety of animal herpes viruses and a few oncogenic RNA viruses. Adenosine monophosphate has been marketed in Europe, the United States, Japan and many other countries. [0003] The English name of adenosine monophosphate is Adenine arabinonucleoside 5'-phosphate, CAS registration number: 29984-33-6, and its structural formula is: [0004] [0005] At present, the dosage forms of adenosine mo...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/7076A61K47/36A61K47/18A61K47/10A61K47/02A61P31/22A61P31/14A61P31/20
Inventor 张隆鑫
Owner GUANGDONG LONGFU MEDICINE CO LTD
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