A kind of preparation method of industrialized production gadopentetate dimeglumine

Abstract

The invention discloses an industrial preparation method of high-purity gadopentetate dimeglumine, which comprises the following steps: mixing and dissolving gadolinium oxide and pentetic acid in water, and reacting to obtain a gadolinium-diethylene triamine pentaacetic acid solution; cooling the gadolinium-diethylene triamine pentaacetic acid solution, adding a meglumine solution, and reacting to obtain a gadopentetate dimeglumine solution; filtering, and concentrating; filtering through a resin column, concentrating the filtrate, and dropwisely adding into anhydrous ethanol; and crystallizing, filtering, and drying to obtain the gadopentetate dimeglumine. According to the invention, the prepared gadolinium-diethylene triamine pentaacetic acid can be directly used for next reaction without being dried, so that the concentrating and drying work time can be shortened by 12-16 hours, and the production cost can be lowered by 5-8%, thereby avoiding the defect that the thick liquid is difficult to dry. The requirement for weighing accuracy of a sample is general, the step of passing through the resin column increases the product purity to 99.5%, the purity of the crystallized product can be up to 99.9%, impurities are removed, the quality risk is eliminated, the product quality is guaranteed, and the medication safety of patients is guaranteed.

Description

technical field [0001] The invention relates to a preparation method of a high-purity magnetic resonance imaging MRI contrast agent gadopentetate meglumine. Background technique [0002] Gadopentetate Dimeglumine, English name Gadopentetate Dimeglumine, alias Gadopentetate Dimeglumine or Magnevist, is a paramagnetic contrast agent used in magnetic resonance imaging. After entering the human body, it can shorten the imaging time of protons in tissues, thereby enhancing the image quality. Clarity and contrast. Medically, it is used for magnetic resonance imaging (MRI) enhancement, including imaging enhancement examination for nervous system, myocardium, liver, breast, bone, kidney and other organs and tissues. [0003] At present, the production process of gadopentetate meglumine is simple. After the product is synthesized, the product is usually obtained by directly drying the viscous liquid. There is a lack of corresponding purification and crystallization methods, and ther...

AI Technical Summary

Problems solved by technology

For such weighing requirements, as well as the transfer and drying of viscous liquids, the production process is difficult to achieve industrial production

[0010] At the same time, since there are no purification, crystallization and other steps in the production process, the raw materials and impurities generated during the reaction process remain in the product, resulting in low product purity, which cannot meet the needs of patients for drug development, and low-quality products pose a serious threat to the life safety of patients. Big hidden dangers, leading to frequent reports of adverse reactions caused by gadopentetate dimeglumine, and even reports of serious adverse reactions and even death cases

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