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Vidarabine monophosphate freeze-dried powder injection and preparation method thereof

A technology of adenosine vidarabine monophosphate freeze-dried powder and adenosine monophosphate, which is applied in the direction of freeze-drying delivery, antiviral agent, powder delivery, etc., and can solve the problems of affecting curative effect, safety hazards, and product safety reduction. , to achieve the effects of fewer types and amounts of auxiliary materials, lower production costs, and lower scrap rates

Active Publication Date: 2013-01-16
HAINAN JINRUI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the addition of a variety of excipients also brings potential safety hazards, leading to a reduction in product safety; it also affects its curative effect to a certain extent

Method used

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  • Vidarabine monophosphate freeze-dried powder injection and preparation method thereof
  • Vidarabine monophosphate freeze-dried powder injection and preparation method thereof
  • Vidarabine monophosphate freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] [Example 1] Preparation of vidarabine monophosphate freeze-dried powder injection

[0057] Prescription (specification 0.1g)

[0058]

[0059]

[0060] Prescription (specification 0.2g)

[0061]

[0062] Preparation Process:

[0063] 1) Cleaning and sterilization of bottles, butyl rubber stoppers and aluminum-plastic combination caps;

[0064] 2) Preparation of medicinal solution: weighing the prescribed amount of adenosine monophosphate raw material. First add adenosine monophosphate raw material drug into the water for injection, slowly add 20% sodium hydroxide solution to a clear solution while stirring, adjust the pH value of the liquid to 7.0, replenish the water for injection to the full amount, add medicinal activated carbon, and circulate Stir, decarbonize, filter, sample, pass the test, filter through a 0.22μm primary sterilizing filter and 0.22μm secondary terminal sterilizing filter, and put it into the liquid medicine barrel for filling;

[0065...

Embodiment 2

[0070] [Example 2] Preparation of vidarabine monophosphate freeze-dried powder injection

[0071] Prescription (specification 0.1g)

[0072]

[0073] Prescription (specification 0.2g)

[0074]

[0075]

[0076] Preparation Process:

[0077] 1) Cleaning and sterilization of bottles, butyl rubber stoppers and aluminum-plastic combination caps;

[0078] 2) Preparation of medicinal solution: weighing the prescribed amount of adenosine monophosphate raw material. First add adenosine monophosphate raw material drug into the water for injection, slowly add 20% sodium hydroxide solution to a clear solution while stirring, adjust the pH value of the liquid to 7.2, replenish the water for injection to the full amount, add medicinal activated carbon, and circulate Stir, decarbonize, filter, sample, pass the test, filter through a 0.22μm primary sterilizing filter and 0.22μm secondary terminal sterilizing filter, and put it into the liquid medicine barrel for filling;

[0079...

Embodiment 3

[0084] [Example 3] Preparation of vidarabine monophosphate freeze-dried powder injection

[0085] Prescription (specification 0.1g)

[0086]

[0087] Prescription (specification 0.2g)

[0088]

[0089] Preparation Process:

[0090] 1) Cleaning and sterilization of bottles, butyl rubber stoppers and aluminum-plastic combination caps;

[0091] 2) Preparation of medicinal solution: weighing the prescribed amount of adenosine monophosphate raw material. First add adenosine monophosphate raw material drug into the water for injection, slowly add 20% sodium hydroxide solution to a clear solution while stirring, adjust the pH value of the liquid to 7.3, replenish the water for injection to the full amount, add medicinal activated carbon, and circulate Stir, decarbonize, filter, sample, pass the test, filter through a 0.22μm primary sterilizing filter and 0.22μm secondary terminal sterilizing filter into the liquid medicine barrel for filling;

[0092]3) The filtrate is subp...

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Abstract

The invention relates to a vidarabine monophosphate freeze-dried powder injection and a preparation method thereof, and the vidarabine monophosphate freeze-dried powder injection is prepared by freeze-drying vidarabine monophosphate, sodium hydroxide solution and water for injection, wherein the sodium hydroxide solution is used as a pH regulator, and the sodium hydroxide solution is used until the pH value of liquid medicine is 7.0-7.5. The vidarabine monophosphate freeze-dried powder injection provided by the invention is few in types of auxiliary materials, low in using amount, good in forming property of a freeze-dried product, good in re-dissolving property, clear in appearance of the solution before freezing, good in clarity after being freeze-dried, low in content of impurities, good in stability and controllable in quality, and can reduce the potential safety hazard of the vidarabine monophosphate freeze-dried powder injection, and improve the efficacy of the vidarabine monophosphate freeze-dried powder injection.

Description

technical field [0001] The invention relates to a medicine and a preparation method, in particular to a vidarabine monophosphate freeze-dried powder for injection 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 Danlinsuan Atangxian'gan, its chemical name is: 9-(β-D-arabinofuranosyl) adenosine 5'-monophos...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/7076A61K47/04A61P31/12A61P31/22
Inventor 钟正明马鹰军王小树罗韬
Owner HAINAN JINRUI PHARMA CO LTD
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