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Vidarabine monophosphate pharmaceutical composition and preparation method thereof

A technology of adenosine vidarabine monophosphate and adenosine vidarabine, which is applied in the field of medicine, can solve problems such as stimulation, and achieve the effects of reducing pain, reducing irritation, and good stability

Active Publication Date: 2014-04-30
HAINAN JINRUI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The pharmaceutical composition not only solves the stimulating effect on muscles and blood vessels during the use of the preparation and the stability of long-term placement, but also has good curative effect

Method used

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  • Vidarabine monophosphate pharmaceutical composition and preparation method thereof
  • Vidarabine monophosphate pharmaceutical composition and preparation method thereof
  • Vidarabine monophosphate pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] [Example 1] Preparation of adenosine monophosphate monophosphate composition for injection

[0048] Prescription: specification 0.1g (calculated as adenosine vidarabine monophosphate)

[0049]

[0050] Preparation:

[0051] (1) Put 500g of hydroxypropyl β-cyclodextrin in 15kg of water for injection, stir at 200rp / min at 60°C for 2h to dissolve the hydroxypropyl β-cyclodextrin, then cool to 30°C, Slowly add 66.7 g of vidarabine under stirring for 1 min to dissolve to obtain solution A;

[0052] (2) Add vidarabine monophosphate and sodium chloride into solution A, stir to dissolve, and obtain solution B;

[0053] (3) Add 79g of activated carbon for needles to the above solution B, keep at 30°C, stir at 400rp / min for 35min, filter through a 4μm water-based filter membrane to remove the needle-use activated carbon, then filter through a 0.2μm water-based filter membrane, and sterilize to obtain sterile filtrate;

[0054] (4) Adjust the filling volume in the center of...

Embodiment 2

[0060] [Example 2] Preparation of adenosine monophosphate and sulfobutyl ether β-cyclodextrin composition for injection

[0061] Prescription: specification 0.1g (calculated as adenosine vidarabine monophosphate)

[0062]

[0063] Preparation:

[0064] (1) Put 400g of sulfobutyl ether β-cyclodextrin in 16kg of water for injection, stir at 200rp / min at 70°C for 2h to dissolve the sulfobutyl ether β-cyclodextrin, then cool to 40°C, Slowly add 40 g of vidarabine under stirring at 500rp / min to dissolve to obtain solution A;

[0065] (2) Add vidarabine monophosphate and sodium chloride into solution A, stir to dissolve, and obtain solution B;

[0066] (3) Add 79g of activated carbon for needles to the above solution B, keep at 40°C, stir at 500rp / min for 25min, filter through a 4μm water-based filter membrane to remove the needle-use activated carbon, then filter through a 0.2μm water-based filter membrane, and sterilize to obtain sterile filtrate;

[0067] (4) Adjust the fi...

Embodiment 3

[0073] [Example 3] Preparation of vidarabine monophosphate for injection

[0074] Prescription: specification 0.1g (calculated as adenosine vidarabine monophosphate)

[0075]

[0076] Preparation:

[0077] (1) Put 572g of carboxymethyl β-cyclodextrin in 16kg of water for injection, stir at 200rp / min at 65°C for 2h to dissolve carboxymethyl β-cyclodextrin, then cool to 35°C, Slowly add 85.8 g of vidarabine under stirring for 1 min to dissolve to obtain solution A;

[0078] (2) Add vidarabine monophosphate and sodium chloride into solution A, stir to dissolve, and obtain solution B;

[0079] (3) Add 79g of activated carbon for needles to the above solution B, keep at 35°C, stir at 450rp / min for 30min, filter through a 4μm water-based filter membrane to remove the needle-use activated carbon, then filter through a 0.2μm water-based filter membrane, and sterilize to obtain sterile filtrate;

[0080] (4) Adjust the filling capacity in the center of the filling machine to 2.5...

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Abstract

The present invention relates to a vidarabine monophosphate pharmaceutical composition and a preparation method thereof. The pharmaceutical composition consists of vidarabine monophosphate, vidarabine, sodium chloride and water-soluble cyclodextrin or a water-soluble cyclodextrin derivative, wherein the mass ratio of vidarabine monophosphate, vidarabine, sodium chloride and water-soluble cyclodextrin or the water-soluble cyclodextrin derivative is 25-35:1-3:1:10-20, preferably 30:2:1:15. The vidarabine monophosphate pharmaceutical composition provided by the present invention has significantly reduced irritation to muscle and blood vessels, and better long-term storage stability. Meanwhile, the vidarabine monophosphate pharmaceutical composition provided by the present invention contains both vidarabine monophosphate and vidarabine, thereby having more significant efficacy. The preparation method for the vidarabine monophosphate pharmaceutical composition is simple and feasible, suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition of adenosine vidarabine monophosphate and a preparation method thereof. Background technique [0002] Vidarabine is a derivative of purine nucleosides, insoluble in water, has good antiviral effect, inhibits the replication of viral genome nucleic acid, and has broad-spectrum anti-herpes virus effect. It has inhibitory effect on herpes simplex virus, varicella-zoster virus and cytomegalovirus in the replication phase, and is still effective on some acyclovir-resistant virus infections. Vidarabine monophosphate is a monophosphate compound of vidarabine, which is easily soluble in water, and its antiviral activity remains unchanged. [0003] Vidarabine monophosphate for injection, English name: Vidarabine Monophosphate for Injection, Chinese pinyin: Zhusheyong Danl insuan Atangxian'gan, its chemical name is: 9-(β-D-arabinofuranosyl) adenos...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/7076A61K47/40A61P31/22
Inventor 钟正明王进宇陈颖江刘春燕
Owner HAINAN JINRUI PHARMA CO LTD
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