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Small numerator modified iron oxide nano-granule freeze-dried powder for injection and preparation method thereof

A technology of iron oxide nanoparticles and small molecules, which can be used in emulsion delivery, MRI/magnetic resonance imaging contrast agent, drug delivery, etc., can solve the problems of long-term storage, non-aggregation, etc. , the effect of low cost

Inactive Publication Date: 2010-10-27
SOUTHEAST UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although small molecule modification can greatly improve the stability of SPIO in solution, it still cannot meet the requirements of non-aggregation for long-term storage.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1: 56 mg (calculated as iron) of citric acid modified iron oxide nanoparticle colloid solution over G 3 Hammer the melting funnel, mechanically stir and mix with the aqueous solution for injection containing 0.5g mannitol and 0.1g Tween 80, use ultrasonic or high-pressure homogenization to further disperse, pass G 3 Hammer melting funnel; fill with nitrogen, heat sterilization at 100°C for 30 minutes to sterilize; pre-freeze at -20°C for 12 hours, freeze-dry for 12 hours to obtain the product.

Embodiment 2

[0029] Embodiment 2: Dimercaptosuccinic acid modified iron oxide nanoparticle colloid solution 56mg (calculated as iron) over G 3 Hammer melting funnel, mechanically stir and mix with the aqueous solution for injection containing 0.8g sorbitol and 0.05g polyethylene glycol 400, use ultrasonic or high-pressure homogenization to further disperse, pass G 3 Hammer melting funnel; filled with nitrogen, sterilized by heating at 100°C for 30 minutes; pre-freezing at -40°C for 12 hours, then freeze-drying for 24 hours.

Embodiment 3

[0030]Embodiment 3: 56 mg (in terms of iron) of glutamic acid-modified iron oxide nanoparticle colloid solution was passed through G 3 Hammer melting funnel, mechanically stir and mix with the aqueous solution for injection containing 1g glucose and 0.12g polyvinylpyrrolidone, use ultrasonic or high-pressure homogenization to further disperse, pass G 3 Hammer melting funnel; filled with nitrogen, sterilized by passing through a 0.22 μm filter membrane; pre-frozen at -30°C for 10 hours, and then freeze-dried for 18 hours.

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PUM

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Abstract

The invention provides micromolecule modifying iron oxide nano particle freeze-dry powder for injection, which consists of micromolecule modifying iron oxide nano particles, freeze-dry protectants and additives, wherein the powder comprises the following components in weight percentage: 0.1 to 40 percent of micromolecule modifying iron oxide nano particle based on iron, 5 to 95 percent of freeze-dry protectant and 1 to 60 percent of stabilizer. The preparation process comprises the following steps: the micromolecule modifying iron oxide nano particle liquid passes through a G3 hammer fused hopper, is evenly mixed with the injection aqueous solution of the freeze-dry protectant and the stabilizer by mechanical stirring, is subjected to ultrasonic or high pressure homogenization to be further dispersed, passes through a G3 hammer fused hopper, is charged with nitrogen gas, is sterilized at the temperature of 100 DEG C for 30 minutes or sterilized by passing a filter membrane with the hole diameter of 0.22mu m, is pre-frozen at the temperature between 40 and 15 DEG C below zero for 6 to 12 hours and is subjected to freeze-drying for 10 to 24 hours, and the micromolecule modifying iron oxide nano particle freeze-dry powder is finally obtained.

Description

technical field [0001] The invention relates to a nuclear magnetic resonance imaging contrast agent, in particular to a small molecule modified iron oxide nanoparticle contrast agent freeze-dried powder for injection and a preparation method. Background technique [0002] Magnetic resonance imaging (Magnetic resonance imaging, MRI) is a very potential diagnostic technique that uses different resonance signals generated by water molecule protons in different tissues of the body under the influence of an external magnetic field for imaging. The strength of the signal depends on the tissue. The water content and the relaxation time of water protons. Compared with computer assisted tomography (CT), X-ray and nuclear imaging, there is no ionization damage caused by radiation, and the resolution is higher. Since the first MRI contrast agent Gd-DTPA (gadolinium-diethylenetriaminepentaacetic acid, trade name: magnetic display meglumine) was successfully developed by Schering AG in ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K49/06A61K49/08A61K49/18
Inventor 熊非顾宁张宇
Owner SOUTHEAST UNIV