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Aztreonam/arginine medicament composition suspension injection

A technology of aztreonam and injection, applied in the field of medicine, can solve the problems of poor stability and short validity period of aztreonam, achieve the effects of reducing drug side effects, low cost, and improving drug therapeutic index

Inactive Publication Date: 2010-07-14
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] After a long period of serious research, the inventors have unexpectedly found that aztreonam suspension granules are prepared by spray drying using emulsification technology, and then mixed with arginine for packaging, which solves the problems of poor stability and short validity period of aztreonam. The present invention has thus been accomplished

Method used

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  • Aztreonam/arginine medicament composition suspension injection
  • Aztreonam/arginine medicament composition suspension injection
  • Aztreonam/arginine medicament composition suspension injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Example 1 Preparation of Suspension Injection of Aztreonam / Arginine Pharmaceutical Composition

[0041] Prescription (100 bottles): Aztreonam 50g

[0042] Sodium deoxycholate 116.7g

[0043] Povidone K30 58.3g

[0044] Sodium bisulfite 2.5g

[0045] Mannitol 200g

[0046] Arginine 35g

[0047] Preparation Process

[0048] (1) Add 116.7g of sodium deoxycholate, 58.3g of povidone K30, and 2.5g of sodium bisulfite into 5000ml of water for injection, then add 50g of aztreonam and mix evenly, heat and stir in a water bath at 80°C to a suspended state;

[0049](2) The above liquid was sheared and stirred with a tissue masher for 20 minutes under the condition of heat preservation at 70-90 ° C, and the rotation speed was 15000 r / min to obtain the first emulsion, and then circulated and emulsified by a high-pressure homogenizer for 5 times to obtain an emulsion;

[0050] (3) Add 200g mannitol to the emuls...

Embodiment 2

[0052] Example 2 Preparation of Suspension Injection of Aztreonam / Arginine Pharmaceutical Composition

[0053] Prescription (100 bottles): Aztreonam 100g

[0054] Sodium deoxycholate 400g

[0055] Povidone K15 200g

[0056] Sodium sulfite 10g

[0057] Mannitol 800g

[0058] Arginine 66g

[0059] Preparation Process

[0060] (1) Add 400g of sodium deoxycholate, 200g of povidone K15, and 10g of sodium sulfite into 18000ml of water for injection, then add 100g of aztreonam and mix evenly, heat and stir in a water bath at 90°C until suspended;

[0061] (2) The above liquid was sheared and stirred with a tissue masher for 10 minutes under the condition of heat preservation at 70-90 ° C, and the rotation speed was 15000 r / min to obtain the first emulsion, and then circulated and emulsified by a high-pressure homogenizer for 5 times to obtain an emulsion;

[0062] (3) Add 800g mannitol to the emulsion, filter ...

Embodiment 3

[0064] Example 3 Preparation of Suspension Injection of Aztreonam / Arginine Pharmaceutical Composition

[0065] Prescription (100 bottles): Aztreonam 50g

[0066] Sodium deoxycholate 160g

[0067] Povidone K30 80g

[0068] Sodium Metabisulfite 2.5g

[0069] Mannitol 300g

[0070] Arginine 36g

[0071] Preparation Process

[0072] (1) Add 160g of sodium deoxycholate, 80g of povidone K30, and 2.5g of sodium metabisulfite into 9000ml of water for injection, then add 50g of aztreonam and mix evenly, heat and stir in a water bath at 70°C until suspended;

[0073] (2) The above liquid was sheared and stirred with a tissue masher for 20 minutes under the condition of heat preservation at 70-90 ° C, and the rotation speed was 15000 r / min to obtain the first emulsion, and then circulated and emulsified by a high-pressure homogenizer for 5 times to obtain an emulsion;

[0074] (3) Add 300g mannitol to the emulsion, filter with...

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Abstract

The invention discloses an aztreonam / arginine medicament composition suspension injection and a preparation method thereof. The aztreonam / arginine medicament composition suspension injection is characterized by comprising the mixture of aztreonam suspension granules and arginine, wherein the weight ratio of the aztreonam suspension granules (metering in aztreonam) to the arginine is 1:0.66-0.72; specifically, the aztreonam suspension granules comprises the following components in parts by weight: 1 part of aztreonam, 3.5-6 parts of surfactant, 0.05-0.1 part of antioxidant and 4-8 parts of excipients; and in particular, the surfactant contains sodium deoxycholate and povidone with the weight ratio of 2:1. Because the aztreonam suspension granules are prepared by applying an emulsification technique through spray drying and then are mixed with the arginine for split charging, the the problems of poor stability and short validity period of the aztreonam are solved, and a satisfactory technical effect is achieved.

Description

technical field [0001] The invention relates to an aztreonam / arginine pharmaceutical composition suspension injection, which belongs to the technical field of medicine. Background technique [0002] Aztreonam, the chemical name is: [2S-[2α, 3β(z)]]-2-[[[1-(2-amino4-thiazolyl)-2-[(2-methyl-4-oxo Generation-1-sulfo-3-azetidinyl)amino]-2-oxoethylene]amino]oxo]-2-methylpropionic acid, the molecular formula is: C 13 h 17 N 5 o 8 S 2 , molecular weight: 435.43, structural formula: [0003] [0004] Aztreonam is a synthetic monocyclic β-lactam antibiotic with high antibacterial activity against most aerobic Gram-negative bacteria, including Escherichia coli, Klebsiella pneumoniae, and Oxitobacter Bacillus aerogenes, Bacillus cloacae, Proteus, Serratia, Citrobacter, Shigella and other Enterobacteriaceae bacteria, as well as influenza bacillus, Neisseria gonorrhoeae, Neisseria meningitidis, etc. Pseudomonas also has good antibacterial effect. [0005] In terms of medicine,...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K31/427A61K47/16A61K47/32A61P31/04
Inventor 陶灵刚
Owner HAINAN LINGKANG PHARMA CO LTD
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