Method for efficiently removing dexamethasone sodium phosphate crystal water

A technology of dexamethasone sodium phosphate and crystal water, which is applied in the chemical industry, can solve the problems of reduced stability of preparations, white spots, and white lumps, and achieve the effects of short heating time, low heating temperature, and improved yield and quality of finished products

Pending Publication Date: 2020-12-08
西安国康瑞金制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Changes in the crystal structure will lead to adverse results such as white spots and white lumps in the injection made of dexamethasone sodium phosphate, resulting in reduced stability of the preparation

Method used

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  • Method for efficiently removing dexamethasone sodium phosphate crystal water
  • Method for efficiently removing dexamethasone sodium phosphate crystal water
  • Method for efficiently removing dexamethasone sodium phosphate crystal water

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A method for efficiently removing crystal water of dexamethasone sodium phosphate, comprising the following steps:

[0026] (1) Get the dexamethasone sodium phosphate sample containing crystal water, place it in the stainless steel tray of the vacuum drying oven (the material thickness of the sample is below 8mm), close the box door, close the air release valve, open the vacuum valve, and open the vacuum pump Power and vacuum;

[0027] (2) After the vacuum degree reaches 80-120Pa, close the vacuum valve first, and then turn off the power supply of the vacuum pump;

[0028] (3) Heat, dry and dehydrate according to the following heating program: raise the temperature to 55°C and keep for 30 minutes; raise the temperature to 75°C and keep for 20 minutes; raise the temperature to 95°C and keep for 10 minutes;

[0029] (4) After heating, drying and dehydration, turn off the power, open the vent valve, and release the vacuum state;

[0030] (5) When the temperature is lower...

Embodiment 2

[0033] A method for efficiently removing crystal water of dexamethasone sodium phosphate, comprising the following steps:

[0034] (1) Get the dexamethasone sodium phosphate sample containing crystal water, place it in the stainless steel tray of the vacuum drying oven (the material thickness of the sample is below 8mm), close the box door, close the air release valve, open the vacuum valve, and open the vacuum pump Power and vacuum;

[0035] (2) After the vacuum degree reaches 80-120Pa, close the vacuum valve first, and then turn off the power supply of the vacuum pump;

[0036] (3) Heat, dry and dehydrate according to the following heating program: raise the temperature to 45°C and keep it for 50 minutes; raise the temperature to 65°C and keep it for 40 minutes; raise the temperature to 85°C and keep it for 30 minutes;

[0037] (4) After heating, drying and dehydration, turn off the power, open the vent valve, and release the vacuum state;

[0038] (5) When the temperature...

Embodiment 3

[0041] A method for efficiently removing crystal water of dexamethasone sodium phosphate, comprising the following steps:

[0042] (1) Get the dexamethasone sodium phosphate sample containing crystal water, place it in the stainless steel tray of the vacuum drying oven (the material thickness of the sample is below 8mm), close the box door, close the air release valve, open the vacuum valve, and open the vacuum pump Power and vacuum;

[0043] (2) After the vacuum degree reaches 80-120Pa, close the vacuum valve first, and then turn off the power supply of the vacuum pump;

[0044] (3) Heat, dry and dehydrate according to the following heating program: raise the temperature to 50°C and keep for 40 minutes; raise the temperature to 70°C and keep for 30 minutes; raise the temperature to 90°C and keep for 20 minutes.

[0045] (4) After heating, drying and dehydration, turn off the power, open the vent valve, and release the vacuum state;

[0046] (5) When the temperature is lower...

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Abstract

The invention belongs to the technical field of chemical engineering, and particularly relates to a method for efficiently removing dexamethasone sodium phosphate crystal water. According to the method, the crystal water in the dexamethasone sodium phosphate sample is efficiently removed by adopting a drying mode of vacuum sectional heating temperature control so that the method has the advantagesof short heating time, low heating temperature, high crystal water removal rate, no need of turning over the sample and the like; the problems that in the prior art, the operation period is long, conditions are not mild, products are prone to denaturation, operation steps are tedious and the like when dexamethasone sodium phosphate is dried to remove crystal water are solved. An injection preparation prepared from dexamethasone sodium phosphate without crystal water obtained by the method does not have white points and white blocks in the transportation and storage processes, is good in product quality stability, and has important significance for improving the yield and the finished product quality of the dexamethasone sodium phosphate injection.

Description

technical field [0001] The invention belongs to the technical field of chemical industry, in particular to a method for efficiently removing crystal water of dexamethasone sodium phosphate. Background technique [0002] Dexamethasone sodium phosphate (DM), also known as dexamethasone, is a white or slightly yellow crystalline powder, odorless, has strong hygroscopicity in the air, is easily soluble in water, slightly soluble in ethanol, and its aqueous solution is Colorless and clear liquid. Dexamethasone sodium phosphate was first produced by Merck Company in the United States in 1960, and in 1962, Organon Pharmaceutical Factory in the Netherlands began to produce its injections. At present, many companies around the world are able to produce dexamethasone sodium phosphate products. my country began to produce dexamethasone sodium phosphate API in 1965, and its injection in 1967. [0003] Dexamethasone sodium phosphate is a kind of adrenal glucocorticoid drugs. Adrenal ...

Claims

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Application Information

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IPC IPC(8): C07J51/00
CPCC07J51/00
Inventor 王培文刘伟李娜蒲飞飞张恒
Owner 西安国康瑞金制药有限公司
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