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Cefuroxime sodium freeze dry power and preparation method thereof

The technology of cefuroxime sodium and cefuroxime acid is applied in the production field of cephalosporin aseptic raw materials, which can solve the problems of difficult subpackaging, many supporting equipment and high recovery cost, and achieves reduction of production cost, environmental pollution and labor. the effect of strength

Inactive Publication Date: 2009-07-29
邢建荣
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] 1. The process is cumbersome, there are many operating steps and operators, and the risk of sterility is high
[0006]2. A large amount of solvent is used in production, which requires a lot of supporting equipment. The investment in solvent recovery equipment is large, the recovery cost is high, and the pollution is large
[0007]3. The product is difficult to crush, the particles are uneven, which affects the dissolution rate and difficult to pack; high moisture (2.5-3.0%), poor product stability
[0008]4. The yield is low, the molar yield is only about 93%

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Example 1: Take 100 g of cefuroxime sodium, add 200 ml of purified water and stir to dissolve at 5-20 ° C, adjust the pH to 6.0-9.0 with sodium bicarbonate, add 10 g of activated carbon for decolorization for 20 minutes, decarburize and filter aseptically, Wash the pipeline system with 10ml of purified water, and mix the filtrate and lotion; inject the above-mentioned filtrate and lotion mixture into the tray or vial of the freeze dryer, quickly cool down to -60--5°C to solidify, and maintain the temperature for 1 -3 hours, start the lyophilizer, slowly heat up to 0-20°C for 1-10 hours under high vacuum, maintain 0-20°C for 1-10 hours, and then slowly raise the temperature for 1-10 hours to 30-60°C, Maintain 30-60 DEG C and dry under high vacuum until the water content reaches below 2.0%, to obtain furocin sodium freeze-dried powder.

Embodiment 2

[0023] Example 2: Suspend 100 g of cefuroxime acid in 500 ml of purified water, control the temperature and add sodium carbonate to adjust the pH to 6.0-9.0 while stirring at 5-20 ° C, add 5 g of activated carbon for decolorization for 30 minutes, decarbonize and filter aseptically, use Wash the pipeline system with 30ml of purified water, and mix the filtrate and lotion. Pour the above-mentioned filtrate and lotion mixture into the tray or vial of the freeze dryer, quickly cool down to -60--5°C to solidify, maintain the temperature for 1-3 hours, start the freeze dryer and slowly heat up under high vacuum 1-10 hours to 0-20°C, maintain 0-20°C for 1-10 hours, then slowly raise the temperature for 1-10 hours to 30-60°C, maintain 30-60°C and dry under high vacuum until the moisture content reaches below 2.0% , to obtain furocin sodium lyophilized powder.

Embodiment 3

[0024] Example 3: Take 100 g of cefuroxime sodium, add 2000 ml of purified water and stir to dissolve at 5-20 ° C, adjust the pH to 6.0-9.0 with sodium hydroxide), add 1 g of activated carbon for decolorization for 40 minutes, and pass through decarburization and sterile filtration , Wash the pipeline system with 100ml of purified water, mix the filtrate and lotion; inject the above-mentioned filtrate and lotion mixture into the tray or vial of the freeze dryer, quickly cool down to -60--5°C to solidify, and maintain the temperature 1-3 hours, start the lyophilizer, slowly heat up to 0-20°C for 1-10 hours under high vacuum, maintain 0-20°C for 1-10 hours, then slowly raise the temperature for 1-10 hours to 30-60°C , maintained at 30-60° C. and dried under high vacuum until the water content reached below 2.0%, to obtain lyophilized powder of furocin sodium.

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Abstract

The invention discloses a Cefuroxime sodium lyophilized powder and a method for preparing the same. The method is characterized in that a Cefuroxime sodium solution is added with active carbon, decolored, subjected to decarbonization and aseptic filtration and washed by purified water; a mixture of a filtrate and an eluant is pressed into a feed tray or a penicillin bottle of a freezedryer; a product with the moisture of Cefuroxime sodium of less than 2 percent is prepared by a lyophilization method; and the method simplifies a process, reduces labor intensity, aseptic risk, production cost and pollution and has rapid dissolution speed, good stability and high yield.

Description

Technical field: [0001] The invention relates to cefuroxime sodium freeze-dried powder and a preparation method thereof, which is applied to the production of cephalosporin aseptic raw materials. Background technique: [0002] The chemical name of cefuroxime sodium: (6R,7R)-7-[2-furyl(methoxyimino)acetamido]-3-carbamoyloxymethyl-8-oxo-5-thia- Sodium 1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate. This product is a semi-synthetic second-generation cephalosporin. It has high antibacterial effect on Staphylococcus aureus, Streptococcus, Klebsiella meningococcus, Escherichia coli, Proteus mirabilis, Salmonella, Shigella, etc. It can resist β-lactamase and is effective against penicillin-resistant Staphylococci. Clinically, it is mainly used for respiratory tract infection caused by sensitive bacteria, pyelonephritis, urinary tract infection and infection of bone, joint, ear, nose, throat, soft tissue, etc. This product enters the cerebrospinal fluid in sufficient amount during me...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/546A61P31/04
Inventor 邢建荣刘伟娜
Owner 邢建荣
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