Unlock instant, AI-driven research and patent intelligence for your innovation.

A kind of carbamide peroxide for injection and its production process

A carbonamide peroxide and production process technology, which is applied in the field of medicine, can solve the problems of high production cost, long cycle, and human injury caused by impurities, and achieve the effects of low cost, short production cycle, and low impurity content

Active Publication Date: 2016-05-11
HEBEI TIANCHENG PHARMA
View PDF4 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, carboamide peroxide for injection is usually prepared by freeze-drying method. The solvent used in this method is not easy to be volatilized and removed, and the non-volatile impurities brought in by raw materials during the preparation process of freeze-drying method will remain in the final product, which will not only affect The quality of the product, residual solvents and impurities will also cause certain harm to the human body
In addition, the production cost of freeze-drying method is high and the cycle is long, which is not conducive to large-scale application of enterprises

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • A kind of carbamide peroxide for injection and its production process
  • A kind of carbamide peroxide for injection and its production process
  • A kind of carbamide peroxide for injection and its production process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Weigh 18 kg of carbonamide, 33.4 kg of 32% hydrogen peroxide aqueous solution, and 1.44 kg of citric acid, and add them to the dissolving tank successively, heat in a water bath at 45° C., stir for 90 minutes, all the solids are dissolved, and the pH of the feed solution is detected to be 1.8.

[0031] Filter the dissolved feed liquid through a 0.45μm filter element, a 0.22μm filter element, and a 0.22μm filter element in sequence, and introduce it into a crystallization tank pre-cooled to 0°C; after the feed liquid in the crystallization tank crystallizes, start to stir the feed liquid, And continue to cool down, stop cooling when it reaches 5±1°C, and import the feed liquid into the storage tank; carry out vacuum filtration on the feed liquid in the storage tank, the vacuum degree is -0.1Mpa, until there is no more liquid flowing out, you can get Solid crystalline.

[0032] The solid crystals were dried at a temperature of 8°C and a relative humidity of 20%, and the d...

Embodiment 2

[0036] Weigh 18 kg of carboxamide, 33.98 kg of 30% hydrogen peroxide aqueous solution, and 1.8 kg of citric acid, and add them to the dissolving tank in turn, heat in a water bath at 50° C., stir for 120 minutes, all the solids are dissolved, and the pH of the feed solution is detected to be 2.0.

[0037] Filter the dissolved feed liquid through a 0.45μm filter element, a 0.22μm filter element, and a 0.22μm filter element in sequence, and introduce it into a crystallization tank pre-cooled to 0°C; after the feed liquid in the crystallization tank crystallizes, start to stir the feed liquid, And continue to cool down, stop cooling when it reaches 5±1°C, and import the feed liquid into the storage tank; carry out vacuum filtration on the feed liquid in the storage tank, the vacuum degree is -0.09Mpa, until there is no more liquid flowing out, you can get Solid crystalline.

[0038] The solid crystals were dried at a temperature of 10° C. and a relative humidity of 20%, and the d...

Embodiment 3

[0042] Weigh 18 kg of carbonamide, 32.03 kg of 35% hydrogen peroxide aqueous solution, and 1.62 kg of citric acid, and add them to the dissolution tank in turn, heat in a water bath at 48° C., stir for 100 minutes, all the solids are dissolved, and the pH of the feed solution is detected to be 1.9.

[0043] Filter the dissolved feed liquid through a 0.45μm filter element, a 0.22μm filter element, and a 0.22μm filter element in sequence, and introduce it into a crystallization tank pre-cooled to 0°C; after the feed liquid in the crystallization tank crystallizes, start to stir the feed liquid, And continue to cool down, stop cooling when it reaches 5±1°C, and import the feed liquid into the storage tank; carry out vacuum filtration on the feed liquid in the storage tank, the vacuum degree is -0.1Mpa, until there is no more liquid flowing out, you can get Solid crystalline.

[0044] The solid crystals were dried at a temperature of 10°C and a relative humidity of 20%, and the dr...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention discloses carbamide peroxide for injection and a production process thereof. The carbamide peroxide comprises carbamide, hydrogen peroxide and citric acid, wherein the molar ratio of the carbamide to the hydrogen peroxide is 1 to 1, and the citric acid is 0.075-0.084 percent by mass of the carbamide. The carbamide peroxide for injection has low content of involatile impurities and excellent stability, and can meet the requirement of clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a carboxamide peroxide for injection and a production process thereof. Background technique: [0002] Carbamide peroxide is clinically used to treat various hypoxemia and fetal distress caused by acute hypoxia, and it is used as powder injection and intravenous drip. [0003] At present, carboamide peroxide for injection is usually prepared by freeze-drying method. The solvent used in this method is not easy to be volatilized and removed, and the non-volatile impurities brought in by raw materials during the preparation process of freeze-drying method will remain in the final product, which will not only affect The quality of the product, residual solvents and impurities will also cause certain harm to the human body. In addition, the high production cost and long cycle of freeze-drying are not conducive to large-scale application in enterprises. Contents of the i...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K31/327A61K47/12A61P39/00
Inventor 王振刚
Owner HEBEI TIANCHENG PHARMA