Purifying method of betamethasone phosphate

A technology of metasone phosphate and purification method, applied in the chemical field, can solve problems such as poor turbidity, no good solution for purification, unfavorable pharmaceutical process, etc., and achieve the effects of good quality, improved turbidity and high purity

Inactive Publication Date: 2017-02-22
HENAN LIHUA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Betamethasone phosphate is an important raw material of betamethasone series drugs. Its production process adopts ester-forming reaction. The betamethasone phosphate obtained by the current production process contains certain impurities, and its turbidity is not good, which is not conducive to As a high-quality raw material to participate in the subsequent pharmaceutical process, there are not many reports on the purification methods of betamethasone phosphate, and there is no good solution for its purification

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] Weigh 100g of crude betamethasone phosphate, dissolve it in purified water, stir for 10 minutes, then slowly add the prepared sodium hydroxide solution, the temperature is not higher than 30°C, adjust the pH value to 8.5, so that the betamethasone phosphate is completely dissolved, stirred for 0.5 hours, and the pH value of the retest remained unchanged;

[0012] Add aluminum sulfate, stir for 30 minutes, and measure the pH value to 8.0-8.5. Use hydrochloric acid to adjust the pH value to 7.5-7.0, stir for 30 minutes and retest the pH value. After the pH value remains unchanged, the water vapor in the interlayer is heated to 70°C, and then the interlayer circulating water is turned on to cool down and stand still for no less than 8 hours;

[0013] Natural filtration: After the filtrate in the filter hopper is filtered, observe whether the filtrate in the liquid-receiving bottle is clear, and then pour it into the container; Pour it into the acidification tank, adjust t...

Embodiment 2

[0015] Weigh 100g of crude betamethasone phosphate, dissolve it in purified water, stir for 10 minutes, then slowly add the prepared sodium hydroxide solution, the temperature is not higher than 40°C, adjust the pH value to 9.0, so that the betamethasone phosphate is completely dissolved, stirred for 0.5 hours, and the pH value of the retest remained unchanged;

[0016] Add aluminum sulfate, stir for 30 minutes, and measure the pH value to 8.0-8.5. Use hydrochloric acid to adjust the pH value to 7.5-7.0, stir for 30 minutes and retest the pH value. After the pH value remains unchanged, the water vapor in the interlayer is heated to 60°C, and then the interlayer circulating water is turned on to cool down and stand still for no less than 8 hours;

[0017] Natural filtration: After the filtrate in the filter hopper is filtered, observe whether the filtrate in the liquid-receiving bottle is clear, and then pour it into the container; Pour it into the acidification tank, adjust t...

Embodiment 3

[0019] Weigh 100g of crude betamethasone phosphate, dissolve it in purified water, stir for 10 minutes, then slowly add the prepared sodium hydroxide solution, the temperature is not higher than 30°C, adjust the pH value to 10.0, so that the betamethasone phosphate is completely dissolved, stirred for 0.5 hours, and the pH value of the retest remained unchanged;

[0020] Add aluminum sulfate, stir for 30 minutes, and measure the pH value to 8.0-8.5. Use hydrochloric acid to adjust the pH value to 7.5-7.0, stir for 30 minutes and retest the pH value. After the pH value remains unchanged, the water vapor in the interlayer is heated to 50°C, and then the interlayer circulating water is turned on to cool down and stand still for no less than 8 hours;

[0021] Natural filtration: After the filtrate in the filter hopper is filtered, observe whether the filtrate in the liquid-receiving bottle is clear, and then pour it into the container; Pour it into the acidification tank, adjust ...

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PUM

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Abstract

The invention discloses a purifying method of betamethasone phosphate. The method comprises the following steps: (A) adding pure water into a purifying tank, adding a crude product of betamethasone phosphate, adding a sodium hydroxide solution, and adjusting the pH value to 8.0-10.0, and waiting until the betamethasone phosphate is totally dissolved; (B) adding aluminum sulfate, stirring and measuring the pH value; if the pH value is 8.0-8.5, adjusting the pH value to 7.5-7.0 with hydrochloric acid, stirring and measuring the pH value again; if the pH value does not change, heating to 50-70 DEG C; and cooling and standing for at least 8 hours; and (C) natural filtering: after the filtrate in a filter funnel is totally filtered, checking the clarity of the filtrate, adjusting the temperature in the tank to 10-20 DEG C, adding hydrochloric acid, adjusting the pH value to 0.5-1.0, standing for at least 8 hours, and filtering to obtain pure betamethasone phosphate. The turbidity of the betamethasone phosphate purified by the method is obviously improved.

Description

technical field [0001] The invention relates to a purification method of betamethasone-based drugs, in particular to a purification method of betamethasone phosphate, and belongs to the field of chemical technology. Background technique [0002] Betamethasone phosphate is an important raw material of betamethasone series drugs. Its production process adopts ester-forming reaction. The betamethasone phosphate obtained by the current production process contains certain impurities, and its turbidity is not good, which is not conducive to As a high-quality raw material to participate in the subsequent pharmaceutical process, there are not many reports on the purification methods of betamethasone phosphate, and there is no good solution for its purification. Contents of the invention [0003] The object of the present invention is to overcome the above-mentioned defects existing in the current purification of betamethasone phosphate, and provide a method for purifying betametha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07J5/00
CPCC07J5/0076
Inventor 姬卫忠潘延斌李合兴
Owner HENAN LIHUA PHARMA
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