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Ferumoxytol injection and preparation method thereof

A technology of Limotux and water for injection, which is applied in the fields of blood diseases, medical formulas, and extracellular fluid diseases, etc., can solve the problems of difficulty in controlling the concentration of Filipino, increasing the number of insoluble particles, and difficulty in meeting quality standards, etc., and achieves convenience Particle size distribution coefficient, convenient quantification and control, and the effect of reducing the particle size distribution coefficient

Active Publication Date: 2016-11-23
CHIA TAI TIANQING PHARMA GRP CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, when the aqueous solution was directly prepared into preparations for intravenous injection, the applicant found that the number of insoluble particles in the prepared preparations increased; The product is not easy to meet the quality standard; in addition, due to the difficulty in controlling the concentration of Filipino in the aqueous solution, there are large batch-to-batch differences in drug production

Method used

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  • Ferumoxytol injection and preparation method thereof
  • Ferumoxytol injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1 The preparation of solid-state phenimostat bulk drug

[0026] Step 1: Reduction reaction

[0027] Dextran T10 (100g) was dissolved in water (300mL), sodium borohydride (3.77g) was added, stirred at 30°C for 24h, and 6M HCl aqueous solution was added dropwise to quench the reaction, and the pH was adjusted to 6.5. The completed reaction solution was transferred into a dialysis bag of MWCO 3kDa, and the dialysis bag was placed in distilled water for dialysis for 24 hours, and the distilled water was replaced every 6 hours. The dialysate was concentrated using a MWCO 3kDa ultrafiltration membrane, and the concentrated solution was filtered through a 0.22 μm filter membrane, and then absolute ethanol was added to the filtrate to obtain a white emulsion. After vacuum concentration, 80 g of a white solid substance, namely reduced dextran T 10, was obtained.

[0028] Step 2: Alkylation reaction

[0029] The reduced dextran T10 (10 g) prepared in step 1 was disso...

Embodiment 2

[0035] Embodiment 2 The preparation method of the colloidal aqueous solution for intravenous injection of Felimo

[0036] Get 13g of Felimex solid bulk drug and 7g of mannitol, add water to properly disperse, adjust the pH to 6-8 with HCl and / or NaOH and constant volume (170ml), filter through 0.22 microns, subpackage and cover, and place Sterilize at 121°C for 15 minutes to obtain the aqueous colloidal solution for intravenous injection of Felimotol (10 tubes).

Embodiment 3

[0037] Embodiment 3 The preparation method of the colloidal aqueous solution for intravenous injection of phenimo

[0038] Take 13g of FELIMOTO solid raw material, add water to properly disperse, add 10g of mannitol, adjust the pH to 6-8 with HCl and / or NaOH and constant volume (170ml), filter through 0.22 micron, pack and cap, Sterilize at 121°C for 15 minutes to obtain the aqueous colloidal solution for intravenous injection of Felimotol (10 vials).

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Abstract

The invention relates to a ferumoxytol injection and a preparation method thereof. The ferumoxytol injection is an injection colloid aqueous solution, comprises ferumoxytol, mannitol and injection water and has a particle size distribution coefficient (PDI) less than 0.21. The preparation method has simple processes and is convenient for industrial production. The ferumoxytol injection contains ferumoxytol colloid particles with uniform particle sizes.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a ferimotol intravenous injection and a preparation method thereof. Background technique [0002] Ferumoxytol, developed by AMAG Pharmaceuticals as an iron substitute, is a polyglucose sorbitol carboxymethyl ether (polyglucose sorbitol carboxymethylether) coated superparamagnetic iron oxide formed Nano colloidal particles, the molecular formula is Fe 5874 o 8752 -C 11719 h 18682 o 9933 Na 414 , with an apparent molecular weight of 750kDa. [0003] In June 2009, the FDA approved the listing of Felimotuo in the United States under the trade name For the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD). The listed dosage form is intravenous injection (colloid aqueous solution), the auxiliary material is mannitol, no preservative, its pH is 6-8, and its osmolality is 270-330mOsmol / kg. [0004] For this type of sup...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/48A61K33/26A61P7/06A61K47/36
Inventor 张喜全顾宁陈博刘彦龙张焕青刘飞董平
Owner CHIA TAI TIANQING PHARMA GRP CO LTD