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Officinal 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 containing no active ingredients, medical preparations containing active ingredients, etc. Inconvenient, affecting the quality of medicines and other problems, to achieve the effect of good appearance, prevent spray bottles, improve appearance shape and porosity

Active Publication Date: 2014-02-26
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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  • Officinal composition of vidarabine monophosphate for injection

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Experimental program
Comparison scheme
Effect test

specific Embodiment 1

[0062] Vidarabine 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 vidarabine for injection. Take adenosine monophosphate and add appropriate amount of absolute ethanol until it is completely dissolved, add water for injection, then slowly add lysine under stirring, add mannitol, and 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 the filtrate Packed into vials, and then freeze-dried.

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

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

[0070] For pre-freezing, put the product into a freeze-drying cabinet that is...

specific Embodiment 2

[0075] Composition of pharmaceutical composition (based on 1000 bottles)

[0076] Vidarabine Monophosphate 2g

[0077] Water-soluble chitosan derivative 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 vidarabine for injection. Take adenosine monophosphate and add an appropriate amount of absolute ethanol until it is completely dissolved, take a water-soluble chitosan derivative and dissolve it in water for injection, and then slowly add lycine while stirring. Amino acid, add mannitol, dissolve all, take 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, and use a 0.22μm micropore After aseptic filtration with a filter membrane, the filtrate was divided into vials and then freeze-dried.

[00...

specific Embodiment 3

[0090] Composition of pharmaceutical composition (based on 1000 bottles)

[0091] Vidarabine Monophosphate 2g

[0092] Water-soluble chitosan derivative 10g

[0093] Lysine 2g

[0094] Mannitol 20g

[0095] Disodium hydrogen phosphate 2g

[0096] Citric acid 0.2g

[0097] A medicinal composition of adenosine monophosphate vidarabine for injection. Take adenosine monophosphate and add an appropriate amount of absolute ethanol until it is completely dissolved, take a water-soluble chitosan derivative and dissolve it in water for injection, and then slowly add lycine while stirring. Amino acid, add mannitol, dissolve all, take pH regulator (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 aseptic filtration with a filter membrane, the filtrate was divided into vials and then freeze-dried.

[0098] The drug solution of vidarabine monophosp...

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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 pharmaceutical preparations, in particular to a pharmaceutical composition of vidarabine monophosphate for injection and a preparation method thereof. Background technique [0002] Vidarabine monophosphate (Ara-AMP) is the monophosphate compound of vidarabine monophosphate (Ara-A), and it is a synthetic adenine nucleoside antiviral drug. It is the second-generation preparation of adenosine vidarabine, and it is currently mainly used in 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. [0003] The English name of vidarabine monophosphate is Adenine arabinonucleoside 5'-phosphate, CAS registration number: 29984-33-6, and its structural formula is: [0004] [0005] At present, most of the dosage forms of adenosine v...

Claims

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Application Information

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Patent Type & Authority Applications(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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