Unlock instant, AI-driven research and patent intelligence for your innovation.

Purification method of gadobutrol

A purification method, the technology of gadobutrol, applied in the field of medicine, can solve the problems of low degree of automation, cumbersome purification process, affecting production efficiency, etc., and achieve the effect of high degree of automation, less purification loss and prolonging the service life

Pending Publication Date: 2022-05-27
JIANGSU HENGRUI MEDICINE CO LTD
View PDF2 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These methods have the problem that the purification process is relatively cumbersome, most steps require manual operation, and the degree of automation is low, which affects production efficiency

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Purification method of gadobutrol
  • Purification method of gadobutrol
  • Purification method of gadobutrol

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Step 1: Preparation of crude gadobutrol

[0028] 100kg of purified water was pumped into the 200L reactor, 9.4kg of concentrated hydrochloric acid was added to stir, 17kg of gadolinium oxide was added to stir, then 50kg of butanol ligand was added, and the reaction solution was heated to 90°C under stirring. 25°C, filter under pressure, and wash with appropriate amount of water. The filtrate containing the product gadobutrol is demineralized by nanofiltration until the conductivity of the solution at the outlet of the waste liquid drops to 100-200 μs / cm. At this time, the conductivity of the feed liquid after nanofiltration is 1300 μs / cm, and the nanofiltration result is transferred to 500L reaction kettle, concentrated under reduced pressure to an internal weight of about 125kg. Yield 90.4%

[0029] Step 2: Preparation of Gadobutrol Finished Products

[0030] Packing, two FPA53 type anion exchange resin columns, one IR-120H type cation exchange resin column: diamete...

Embodiment 2

[0035] Gadobutrol Finished Product Preparation and Resin Bed Reuse:

[0036] The resin column used in Example 1 is activated by acid and alkali again after purifying gadobutrol (FPA53 type anion exchange resin: pure water rinses the resin column, 21 kg of 10% NaOH aqueous solution is slowly rinsed, pure water rinses the resin column until the conductivity of the clean water flowing out of the resin. Less than 40μS / cm.IR-120H type cation exchange resin: pure water rinses the resin column, 21kg of 5% HCl aqueous solution slowly rinses, pure water rinses the resin column until the conductivity of the clean water flowing out of the resin is less than 10μS / cm).

[0037] Another batch of 33kg gadobutrol crude concentrate prepared according to the method of Example 1 was eluted using the anion-yang-anion three resin columns that were repeatedly activated, and then 33kg purified water was used to rinse the resin bed to collect the final eluent , the water washing solution was concentr...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention relates to a purification method of gadobutrol. Specifically, the purification method of the gadobutrol comprises the step of purifying the gadobutrol through nanofiltration and the like. The method is high in yield, good in purification effect and suitable for industrial production.

Description

technical field [0001] The present disclosure belongs to the field of medicine, and relates to a purification method of gadobutrol. Background technique [0002] The NMR contrast agent developed by Bayer under the trade name of Gadovist is a 1.0mol / L high-concentration gadobutrol aqueous solution with the molecular formula C of gadobutrol. 18 H 31 GdN 4 O 9 , the chemical name is 10-(2,3-dihydroxy-1-hydroxymethylpropyl)-1,4,7,10-tetraazacyclododecane-1,4,7-triacetate gadolinium complex . The product was first approved in Switzerland in February 1998, and has since been launched in Australia, Canada, the European Union, the United States and other countries. Currently, Gadovist is approved in more than 100 countries around the world. The indications listed in the United States are blood-brain barrier (BBB) ​​and / or central nervous system imaging in adults and children (including neonates), and imaging of malignant breast diseases. Gadobutrol is one of the three low-ris...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
IPC IPC(8): C07D257/02
CPCC07D257/02
Inventor 王洪森朱汉帅梁荣兴徐雷孔祥启
Owner JIANGSU HENGRUI MEDICINE CO LTD