Ferric pyrophosphate citrate mixed complex preparation method

Abstract

The invention discloses a ferric pyrophosphate citrate mixed complex preparation method, which comprises: (1) preparing an aqueous solution containing trivalent iron cations; (2) respectively preparing an aqueous solution containing citric acid anions and an aqueous solution containing pyrophosphoric acid anions, slowly adding the aqueous solution containing pyrophosphoric acid anions into the aqueous solution containing citric acid anions in a dropwise manner, and uniformly stirring and mixing to obtain a mixed aqueous solution; (3) slowly adding the aqueous solution prepared in the step (1) into the mixed aqueous solution prepared in the step (2) while stirring, carrying out a stirring reaction for 1-2 h after completing the adding to obtain a dark green solution, filtering out insoluble matters, and taking the filtrate; and (4) adding the filtrate obtained in the step (3) into a crystallization solvent in a dropwise manner, continuously stirring for 1-2 h after completing the adding to obtain a slight green precipitate, filtering, and drying the obtained solid so as to obtain the ferric pyrophosphate citrate mixed complex. According to the present invention, with the preparation method, the high-yield phosphate-radical-free ferric pyrophosphate citrate having the low organic impurity content can be stably obtained.

Description

technical field [0001] The invention relates to a preparation method of iron citric acid pyrophosphate complex. It belongs to the field of medical technology. Background technique [0002] Chronic kidney disease (chronic kidney disease, CKD) has become a serious disease that threatens human health around the world. The incidence of CKD in European and American countries is between 6 and 16%. With the development of China's national economy and health services, and the improvement of people's living standards, the incidence of CKD reported in Shanghai, Beijing, Guangzhou and other major cities is similar to that of developed countries, or even higher. At present, the dialysis centers of hospitals at all levels in China are overcrowded, which brings a heavy burden to families and national finances. CKD is being highly valued by international nephrology experts, health administration departments and national policy-making departments, including Chinese scholars. The incidenc...

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Problems solved by technology

[0008] (1) Due to the poor stability of pyrophosphate in its aqueous solution, especially in the environment of high temperature, pyrophosphoric acid is easily decomposed into the main impurity phosphate of citrate ferric pyrophosphate mixed complex in the preparation process, Although the literature has noticed this, it is pointed out in the examples that unless it is dried at 105°C, the product does not contain phosphate, and it is chosen to add ferric sulfate solution at 15-75°C to avoid the generation of phosphate as much as possible, but from There are still many batches of phosphate radical content > 1% in the detection data of the example that literature gives, and we from the thermoanalysis (TG, DSC) collection of spectra ( figure 2 ) found that the sample had an obvious endothermic peak at 75.5°C due to the decomposition of the sample. Partial decomposition begins at about ℃, and the temperature is higher than this temperature in the process of reaction and post-treatment, so it is difficult to guarantee the quality of the product

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