Sub-micro emulsion frozen preparation of aztreonam

A freeze-dried preparation, aztreonam technology, applied in the field of freeze-dried preparations of aztreonam microemulsion, can solve the problems of high raw material and environmental requirements, thermal instability of double emulsion, poor stability of aqueous solution, etc., and achieve stable product quality, Reduce drug side effects and improve stability

Inactive Publication Date: 2009-10-07
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the dosage form of aztreonam on the market is a sterile subpackage preparation, which has high requirements on raw materials and the environment, and the cost is relatively high; while the aqueous solution of aztreonam has poor stability and is not suitable for making aqueous injection preparations
[0006] In recent years, multiple emulsions are also called multiple emulsions, especially the W / O / W type. Due to the existence of two interfacial membrane surfaces and an oil phase, the active ingredients embedded in the inner water phase are well protected. , is expected to have good application prospects in cosmetics, food, medicine and other industries; however, the two-layer interface is a complex dispersion system with high interfacial free energy, which leads to thermodynamic instability of the double emulsion, often delamination or sedimentation, Flocculation, coalescence, deformation or phase change, thereby limiting the successful application of double emulsions

Method used

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  • Sub-micro emulsion frozen preparation of aztreonam
  • Sub-micro emulsion frozen preparation of aztreonam
  • Sub-micro emulsion frozen preparation of aztreonam

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 2

[0069] Embodiment 2 prepares aztreonam microemulsion freeze-dried preparation

[0070] Recipe: Aztreonam 100g

[0071] Polyethylene glycol / polylactic acid copolymer 400g

[0072] Polyvinyl alcohol 100g

[0073] Mannitol 260g

[0074] Povidone K15 15g

[0075] Preparation Process

[0076] (1) Dissolve 100g of aztreonam in 1500ml of water, 400g of polyethylene glycol / polylactic acid copolymer in 500ml of isopropanol, mix and stir for 15min at a speed of 600r / min to make a W / O emulsion ;

[0077] (2) Dissolve 260g of mannitol and 15g of povidone K15 in 1000ml of water, add the solution to the above-mentioned W / O emulsion, stir at room temperature for 30min, and rotate at 100r / min to make a W / O / W type double emulsion;

[0078] (3) Add the above-mentioned W / O / W type double emulsion into the aqueous solution of 100g polyvinyl alcohol, stir at room temperature for 60min, and rotate at 600r / min, evaporate isopropanol under reduced pressure, centrifuge at ...

Embodiment 3

[0081] The preparation of embodiment 3 aztreonam microemulsion freeze-dried preparation

[0082] Recipe: Aztreonam 200g

[0083] Polylactic acid / glycolic acid copolymer 300g

[0084] Lecithin 80g

[0085] Tween 80 50g

[0086] Lactose 500g

[0087] Dextran 40 58g

[0088] Preparation Process

[0089] (1) 200g of aztreonam was dissolved in 2000ml of water, 300g of polylactic acid / glycolic acid copolymer was dissolved in 1000ml of dichloromethane, the two were mixed and stirred for 20min, and the rotating speed was 300r / min to make a W / O emulsion;

[0090] (2) Dissolve 58g of dextran 40 and 500g of lactose in 1000ml of water, add the solution to the above-mentioned W / O type emulsion, stir at room temperature for 30min, and rotate at 200r / min to make W / O / W type double emulsion;

[0091] (3) Add the above-mentioned W / O / W type double emulsion into an aqueous solution of 80g lecithin and 50g Tween 80, stir at room temperature for 50min, and rotate...

Embodiment 4

[0094] Example 4 Quality Research

[0095] The samples prepared in the above examples and the marketed aztreonam powder injection (Shanxi Pude Pharmaceutical Co., Ltd., batch number 20080916) were placed at a high temperature of 60°C and a light of 4500Lx for 10 days to conduct an experimental investigation of the influencing factors. The results are shown in Table 1 ;At a high temperature of 40°C and a relative humidity of 75%±5% for 6 months, an accelerated test was carried out, the results are shown in Table 2; at a high temperature of 25°C and a relative humidity of 60%±10% for 18 months, a long-term test was carried out Investigate and detect the changes of various quality indicators, the results are shown in Table 3.

[0096] Table 1 Results of influencing factors

[0097]

[0098]

[0099] Table 2 Accelerated test results

[0100]

[0101] Table 3 Long-term test results

[0102]

[0103]

[0104] From the above results, it was found that the clarity of...

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Abstract

The invention provides a sub-micro emulsion frozen preparation of aztreonam and a preparation method thereof. The frozen preparation is prepared mainly with the following components according to parts by weight: 1-20 portions of aztreonam, 1-40 portions of biodegradable polymer, 1-20 portions of emulsifying agent, 10-50 portions of skeleton supporting agent and 0.5-20 portions of stabilizing agent.

Description

technical field [0001] The invention relates to an aztreonam submicroemulsion preparation, in particular to a aztreonam sub microemulsion freeze-dried preparation prepared by a double emulsion method. Background technique [0002] Aztreonam, the chemical name is: [2S-[2α, 3β(z)]]-2-[[[1-(2-amino-4-thiazolyl)-2-[(2-methyl-4- Oxo-1-sulfo-3-azetidinyl)amino]-2-oxoethylene]amino]oxo]-2-methylpropionic acid, the molecular formula is: C 13 h 19 N 5 o 8 S 2 , molecular weight: 437.44, 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. Clinica...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K9/107A61K31/427A61K47/42A61K47/36A61K47/34A61K47/32A61P31/04A61P13/02A61P11/00A61P7/00A61P15/00A61P17/02A61K47/10A61K47/26
Inventor 王明
Owner HAINAN LINGKANG PHARMA CO LTD
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