A kind of ultrafiltration process of injection solution for mri or ct imaging

Abstract

The invention discloses an ultrafiltration process of an injection for MRI or CT contrast, wherein (1) the ultrafiltration adopts a polyethersulfone 10kD ultrafiltration membrane bag, and the area of ​​a single membrane bag is 1-2m2; (2) the ultrafiltration The filtration process uses two ultrafiltration membrane packages (ultrafiltration membrane package 1 and ultrafiltration membrane package 2) in series, and a sampling point is set between the two ultrafiltration membrane packages to detect the filtrate passing through the ultrafiltration membrane package 1 Finally, if the bacterial endotoxin level of the filtrate is not less than 0.2 EU / ml, it is filtered through the ultrafiltration membrane bag 2 to obtain the final filtrate. The inventor creatively adopted the series connection of two specific ultrafiltration membrane packs, and explored the best process parameters and ultrafiltration membrane pack categories, thereby realizing the industrial application of the ultrafiltration process for high-viscosity injections, not only avoiding the use of activated carbon The pH drop caused by the removal of bacterial endotoxins makes the process simpler, ensures a low level of bacterial endotoxins in the product, and further reduces production costs.

Description

technical field [0001] The invention relates to an ultrafiltration process for medicinal injections, in particular to an improved ultrafiltration process for removing bacterial endotoxins from high-viscosity injections for MRI or CT imaging. Background technique [0002] Injection for MRI or CT contrast is an injection for intravenous administration, and the content of bacterial endotoxin in the product is the key point of control. In the past production of injection solutions, activated carbon adsorption was used to remove bacterial endotoxins in the solution. [0003] In addition to absorbing certain bacterial endotoxins, activated carbon can also decolorize the solution, but it has a great influence on the pH value of the injection solution for MRI or CT contrast, which decreases linearly. The dosage of 0.5% activated carbon reduces the pH value by 0.5% unit, so only 0.1% of activated carbon is used in our production process, which limits its adsorption to bacterial endo...

AI Technical Summary

Problems solved by technology

[0006] In order to solve the above-mentioned technical problems in the prior art, the present invention provides an ultrafiltration process for MRI or CT contrast injection, which can not only reduce the dependence on specific high-standard ultrafiltration membrane packs, but also improve The recovery rate of the drug can be improved, and the problem of incomplete retention of bacterial endotoxin caused by problems such as flow rate, pressure, and membrane integrity in the first-stage ultrafiltration process can be avoided, resulting in unqualified product quality.