Production method of prednisolone sodium phosphate

Abstract

The invention discloses a production method of prednisolone sodium phosphate. The production method comprises the following steps: taking prednisolone phosphate as a raw material, dissolving the prednisolone phosphate in a tank by using a mixed solution of acetone and water, dropwise adding a sodium hydroxide water solution into the tank, controlling the temperature to be 10-25 DEG C, adjusting the pH value to 9.0-9.5, carrying out stirring, re-measuring the pH value to ensure that the pH value is not changed, then carrying out filtering, pumping acetone into the dilution tank, adjusting the temperature, adding a reaction solution, carrying out stirring to separate out a large amount of crystals, carrying out standing for no less than 8 hours, carrying out discharging, then carrying out washing with acetone, carrying out dry-spinning, and carrying out drying to obtain the prednisolone sodium phosphate. According to the method, a plurality of solvents in a conventional process are changed into a single solvent, so that the bottleneck that residual solvents in raw materials are diversified is solved, and the drying time is shortened by a half. The total amount of impurities in the prednisolone sodium phosphate obtained by the method disclosed by the invention is less than 2.0%, and the production method has great advantages in quality.

Description

technical field [0001] The invention relates to medicine production technology, in particular to a method for producing salt of prednisolone sodium phosphate, which belongs to the technical field of pharmacy. Background technique [0002] The clinical use of prednisolone sodium phosphate is an adrenal cortex hormone drug. It has various pharmacological effects such as anti-inflammatory, anti-allergic and immune suppression. Anti-inflammatory effect: Glucocorticoids reduce and prevent tissue responses to inflammation, thereby reducing the manifestations of inflammation. Immunosuppressive effects: prevent or inhibit cell-mediated immune responses, delay allergic reactions, and mitigate the expansion of primary immune responses. Anti-toxic and anti-shock effects: Glucocorticoids can resist the stimulation of bacterial endotoxins on the body, reduce cell damage, and play a role in protecting the body. The applicant's Chinese Patent No. 201310539987.X (a production process for...

AI Technical Summary

Problems solved by technology

However, with the development of the situation, the following problems have occurred in the production of this process. In this process, methanol is firstly used to dissolve, and then added to the ethanol tank. In the process of production, various solvents are used, so the last in the process The waste liquid contains methanol and ethanol. This mixed solvent cannot be recycled, and the mixture of methanol and ethanol is difficult to separate. If it is separated, a high-purity rectification tower is required. The investment in high-purity rectification tower equipment is large. It is not cost-effective for the enterprise to invest in a high-purity rectification column for the purpose of separating this waste, which will lead to a large increase in the operating cost of the enterprise, but it will not make a positive contribution to economic benefits. Furthermore, the current strict control of environmental protection This kind of waste liquid is not allowed to be discharged at will, so the treatment of this waste liquid produced after adopting this process is a big problem for enterprises. Enterprises can only use storage tanks to temporarily store these waste liquids, but it can only be On the other hand, the variety of solvents used in the process results in a wide variety of solvent residues in the final product

Moreover, since ethanol has a boiling point of 78.4°C, more impurities will be produced during the drying process for a long time. The final impurity content in this process is between 1.5-2.5%, which affects the quality of steroids