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A kind of superparamagnetic iron oxide endotoxin removal method

A superparamagnetic iron oxide, endotoxin technology, applied in iron oxide, iron oxide/iron hydroxide, nanotechnology for materials and surface science, etc.

Active Publication Date: 2020-12-25
BRIGHTGENE BIO MEDICAL TECH (SUZHOU) CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the prior art has not reported an effective and simple method for removing endotoxin from superparamagnetic iron oxide raw materials

Method used

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  • A kind of superparamagnetic iron oxide endotoxin removal method
  • A kind of superparamagnetic iron oxide endotoxin removal method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Dissolve 100g of dextran 10 (PSC) in 200ml of water, add 2g of 50% sodium hydroxide solution, add 1.6g of sodium borohydride, react at room temperature for 4 hours, add 80.0g of 50% sodium hydroxide at no higher than 25°C, Bromoacetic acid 27.8g, react at room temperature for 16 hours, adjust the pH of the system to 6.2 with 6M hydrochloric acid, add 5000ml of ethanol to form a white precipitate, remove the supernatant, dissolve the residue in 240ml of water, add 800mg of sodium chloride, and add 120ml of ethanol to form White precipitate, repeat the above purification twice, dissolve the residue in 120ml of water, add 1L of ethanol, a white solid precipitates, filter, and dry at 50°C for 24 hours to obtain PSC.

[0022] PSC (40g) was dissolved in 850ml of water, ferric chloride hexahydrate (29.9g) and ferrous chloride tetrahydrate (14.9g) were dissolved in 373ml of water, filtered with a 0.2um filter, mixed, and In the reaction bottle, cool down to 10°C, protect it wit...

Embodiment 2

[0024] The crude drug that embodiment 1 obtains carries out the mensuration of endotoxin according to the following method:

[0025] Bacterial endotoxin test method (General Rule 1143 of Chinese Pharmacopoeia 2015 Edition)

[0026] Operation process:

[0027] (1) Instruments and equipment

[0028] Vortex mixer, precision pipette, electric thermostat.

[0029] (2) Test equipment

[0030] Non-pyrogenic sampling spoon, non-pyrogenic empty ampoule, disposable non-pyrogenic tip.

[0031] (3) Test drug

[0032] 》=0.125EU / ml Limulus Reagent, Bacterial Endotoxin Working Standard, Bacterial Endotoxin Test Water

[0033] (4) Test process

[0034] According to the "Chinese Pharmacopoeia" 2015 edition of the Chinese Pharmacopoeia General Rule 1143, the bacterial endotoxin detection method is as follows:

[0035] According to the results of the interference test, the sensitivity of the LAL reagent was selected in this test as 0.125 EU / ml, and the maximum effective dilution factor of...

Embodiment 3

[0056] Add sodium hydroxide to the bulk drug concentrate obtained in Example 1 until the overall concentration of sodium hydroxide in the concentrate is 10%, heat it to 80°C for 2 hours, cool down to room temperature naturally, and remove the added strong base by ultrafiltration , after adjusting the concentration, the endotoxin and particle size were measured according to the method of Example 2. The measured endotoxin level was 6.25-12.5Eu / ml, and the particle size was 60.39nm.

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Abstract

The invention provides a method for removing endotoxin from superparamagnetic iron oxide bulk drugs simply and effectively. The endotoxin is removed by using a strong alkali and sodium hypochlorite mixed solution with certain concentration.

Description

technical field [0001] The invention belongs to the field of medicinal chemistry and relates to the preparation of raw materials of intravenous iron preparations, in particular to a method for removing endotoxin in superparamagnetic iron oxide raw materials. Background technique [0002] Superparamagnetic iron oxide (Ferumoxytol) is a nanoparticle formed by wrapping superparamagnetic iron oxide with polydextrose sorbitol carboxymethyl ether. The injection of the drug was approved by the FDA in 2009 for the treatment of adult patients with chronic kidney disease (CKD) of iron deficiency anemia. [0003] Iron-deficiency anemia (IDA) is anemia in which iron stores in the body cannot meet the needs of normal erythropoiesis. It is caused by insufficient iron intake, decreased absorption, increased requirement, impaired iron utilization, or excessive iron loss. Morphology showed microcytic hypochromic anemia. Iron deficiency anemia is not a disease, but a symptom of the disease...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K33/26A61K9/51A61P7/06C01G49/06B82Y30/00
CPCA61K9/5161A61K33/26A61P7/06B82Y30/00C01G49/06C01P2004/64
Inventor 袁建栋张强李荣山
Owner BRIGHTGENE BIO MEDICAL TECH (SUZHOU) CO LTD