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A kind of zanamivir injection and preparation method thereof

A technology for zanamivir and injection, applied in the field of zanamivir injection and its preparation, can solve the problems of low dosage, difficult to meet clinical needs, and inconvenient use

Active Publication Date: 2015-12-30
北京金康驰医药投资有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Although the existing drug delivery method can overcome the problem of short elimination half-life, it is inconvenient to use and the dosage is low, so it is difficult to meet the clinical needs, especially the needs of critically ill patients
Intravenous administration can overcome the defect of low dosage of nasal administration, but the problem of short half-life needs to be overcome

Method used

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  • A kind of zanamivir injection and preparation method thereof
  • A kind of zanamivir injection and preparation method thereof
  • A kind of zanamivir injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Example 1: Zanamivir injection

[0040] 1. Composition:

[0041]

[0042] 2. Preparation method:

[0043] 1) Take zanamivir, heat and stir for 10-20min, and mix well.

[0044] 2) Take 700ml of water for injection, add Tween 80, polyvinylpyrrolidone, polylactic acid and sodium chloride.

[0045] 3) Under nitrogen protection and stirring conditions, mix the solution of step 1 with the solution of step 2, adjust the total amount to 1000ml with water for injection, adjust the pH value of the injection to 5.5, filter, sub-pack, pass nitrogen, seal, Sterilize by autoclaving at 110-130℃ for 10-20 minutes, and package after passing the lamp inspection.

Embodiment 2

[0046] Example 2: Zanamivir injection

[0047] 1. Composition: zanamivir 180.0g, sodium chloride 170.0g, 100g Tween 80 and polyvinylpyrrolidone, added to 20.0L with water for injection.

[0048] 2. Preparation method:

[0049] Add a total amount of 10L water for injection to the concentrated preparation tank, weigh 183.6g of zanamivir into the liquid preparation tank, stir to dissolve, then add the prescribed amount of sodium chloride, Tween 80 and polyvinylpyrrolidone after stirring and dissolving , add 5g of activated carbon for injection (equivalent to 0.05% of the concentrated volume), stir for about 15 minutes, filter to remove carbon, then filter through a 0.45μm filter to the dilute preparation tank, add water for injection to nearly the full amount, stir evenly, and control The pH value of the injection solution was 5.5, and the sample was tested. After passing the inspection of the semi-finished product, it is finely filtered with a 0.22 μm filter element, potted, a...

Embodiment 3

[0050] Example 3: Zanamivir Injection

[0051] 1. Composition: zanamivir 210.0g, sodium chloride 190.0g, 100g Tween 80 and polyvinylpyrrolidone were added to 20.0L with water for injection.

[0052] 2. Preparation method:

[0053] Add a total amount of 10L water for injection into the concentrated preparation tank, weigh 214.2g of zanamivir in the preparation liquid tank, stir to dissolve, then add the prescribed amount of sodium chloride, Tween 80 and polyvinylpyrrolidone are stirred and dissolved. , add 5g of activated carbon for injection (equivalent to 0.05% of the volume of concentrated preparation), stir for about 10 minutes, filter to remove carbon, and then filter through 0.45μm filter element to the dilute preparation tank, add water for injection to nearly the full amount, stir evenly, control The pH value is in the range of 4.5-6.5, and the sample is tested. After passing the inspection of the semi-finished product, it is finely filtered with a 0.22 μm filter elem...

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Abstract

The invention relates to a zanamivir injection. The injection contains zanamivir, sodium chloride, polysorbate 80, polyvinylpyrrolidone, water for injection and / or polylactic acid. The pH (potential of Hydrogen) value of the injection is 4.5-6.5.

Description

technical field [0001] The present invention relates to a preparation of zanamivir, in particular to a zanamivir injection and a preparation method thereof. Background technique [0002] Zanamivir, an influenza virus sialic acid inhibitor, is mainly used for the prevention and treatment of influenza. Its structural formula is as follows: [0003] [0004] Zanamivir, the chemical name is N-acetyl-2,3-dideoxy-4-guanidinosialic acid (referred to as 4-guanidino-neurami-5-acetyl-2-ene), or 5- Acetylamino-4-[(aminoiminomethyl)-amino]-2,6-hydro-3,4,5-trideoxy-D-glyceryl-D-galactose-2-enolic acid . Developed by GlaxoWellcome, it was approved by the FDA for the treatment of influenza A and B in August 1999. Zanamivir is the first licensed influenza treatment drug since rimantadine was approved for marketing in 1993. Its marketed dosage form is Oral spray, the formulation consists of 5 mg of zanamivir and 20 mg of lactose. [0005] The pharmacokinetics of zanamivir in mice wer...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/351A61K47/34A61K47/32A61P31/16
Inventor 余美荣杨惠超韩斌
Owner 北京金康驰医药投资有限公司