Production method of prednisolone sodium phosphate
A technology of prednisolone sodium phosphate and prednisolone phosphate, which is applied in the field of drug production and salt formation of prednisolone sodium phosphate, can solve the problem of no positive contribution to economic benefits, increased operating costs of enterprises, and impact on steroids. Quality and other problems, to achieve the effect of simple structure, short drying time and shortening drying process time
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[0008] Example 1:
[0009] Weigh 100g of prednisolone phosphate and dissolve it in 8 times the mixed solvent of acetone and water. The volume ratio of acetone to water in the mixed solution of acetone and water is 1:2. Adjust the pH to 9.5 with aqueous sodium hydroxide. , The temperature is controlled at 10-15℃, and the liquid is filtered. The material liquid is diluted in acetone with a ratio of 25 times, stirred to obtain a large amount of crystals and left for 9 hours, filtered, and dried after obtaining the material. The total amount of impurities is 1.3%. The product quality meets the standards of EP9.0 and USP39.
Example Embodiment
[0010] Example 2:
[0011] Weigh 100g of prednisolone phosphate and dissolve it in 10 times the mixed solvent of acetone and water. The volume ratio of acetone to water in the mixed solution of acetone and water is 3:2. Adjust the pH to 9.2 with aqueous sodium hydroxide. , The temperature is controlled at 15-20℃, and the liquid is filtered. The material liquid is diluted 20 times in acetone, stirred to obtain a large amount of crystals and left for 8.5 hours, filtered, and dried after the material is obtained. The total amount of impurities is 1.5%. The product quality meets the standards of EP9.0 and USP39.
Example Embodiment
[0012] Example 3:
[0013] Weigh 100g of prednisolone phosphate and dissolve it in a mixed solvent of acetone and water. The volume ratio of acetone to water in the mixed solution of acetone and water is 1.5:6. Adjust the pH to 9.3 with aqueous sodium hydroxide. The temperature is controlled at 20-25℃, and the liquid is filtered. The material solution is diluted in acetone with a ratio of 16 times, stirred to obtain a large amount of crystals, and then allowed to stand for 8 hours, filtered, and dried after obtaining the material. The total amount of impurities is 1.6%. The product quality meets the standards of EP9.0 and USP39.
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