A preparation method of high-purity 16α-hydroxyprednisolone
By using potassium permanganate oxidation, addition reaction in mixed solvents of chloroalkane and alcohols and alkali treatment under nitrogen atmosphere during the production process of 16α-hydroxyprednisolone, the impurity Z1 was successfully removed, and the problems of low product purity and yield in the prior art were solved, and efficient preparation of high-purity 16α-hydroxyprednisolone was achieved.
Patent Information
- Application Number
- CN202510062816.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-01-15
- Publication Date
- 2025-04-04
AI Technical Summary
The by-product Z1 in the existing 16α-hydroxyprednisolone production process is converted into impurity Z2, which affects the purity and yield of the product. The conventional refining system requires multiple refining, which increases cost and complexity.
By reacting the 16α-hydroxyprednisolone eliminator with potassium permanganate in a ketone organic solvent, and then reacting with sodium hypochlorite or sodium hypobromide in a mixed solvent of chloroalkane and alcohol, further reacting with the mixed alkali liquid under a nitrogen atmosphere, impurity Z1 is gradually removed, and a high-purity 16α-hydroxyprednisolone is prepared.
The content of impurity Z1 in 16α-hydroxyprednisolone acetate is significantly reduced, the purity and yield of the product is improved, the potential impact of subsequent reactions and product quality is reduced, and the consistency and stability of the product are ensured.