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

Active Publication Date: 2019-07-09
HENAN LIHUA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[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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PUM

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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...

Claims

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Application Information

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IPC IPC(8): C07J51/00
CPCC07J51/00
Inventor 姬卫忠李合兴黄燕鸽孟栋梁潘严彬宋张胜
Owner HENAN LIHUA PHARMA
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