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Medicine composite of superfine sterile sodium carbonate and cephems

A technology of sodium carbonate and composition, applied in the field of medicine, can solve the problems of insoluble, inconsistent, no specific measurement method, etc., and achieve the effect of rapid dissolution and convenient clinical use

Active Publication Date: 2010-12-29
GUANGZHOU BAIYUSN TIANXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The ceftazidime powder for injection currently on the market has the disadvantage that it is difficult to dissolve with electrolyte solution or glucose solution and other infusions during clinical use; Commonly used infusion solutions are difficult to dissolve at low temperatures according to routine operations
[0003] CN100336510C has disclosed composition ratio, pH value, color and dissolving time of cefpiramide and sodium carbonate composition in its instruction manual, although its dissolving time is 30~120 seconds not etc., does not have concrete measuring method, according to its quality standard (Standard No.: YBH05752008) and the relevant provisions of the "Chinese Pharmacopoeia" to verify it, it can be seen that the pH, color, dissolution time and other data in CN100336510C are based on the new boiling and cooling to 25 ± 2 ° C Purified water is quickly injected for dissolution determination, and the dissolution time, pH value and other data measured by purified water under other conditions and using electrolyte solution, glucose solution and other infusions are inconsistent with those disclosed in CN100336510C
[0008] By searching the literature, no relevant reports about the preparation method of ultrafine (particle size <20 μm) sterile sodium carbonate and its use in medicines have been retrieved

Method used

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  • Medicine composite of superfine sterile sodium carbonate and cephems
  • Medicine composite of superfine sterile sodium carbonate and cephems
  • Medicine composite of superfine sterile sodium carbonate and cephems

Examples

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example 1

[0032] The preparation of example 1 ultrafine aseptic sodium carbonate

[0033] Weigh 1.5kg of anhydrous sodium carbonate, add 3.5 liters of water for injection and heat up to 40-45°C to dissolve to make a 30% sodium carbonate solution, filter aseptically through a 0.22 micron filter element to obtain a sterile solution of sodium carbonate, and use a clean and dry Sterile air or nitrogen, air inlet temperature 125±5℃, airflow pressure 0.4MPa, outlet temperature 80±2℃, solution flow rate 30ml / min, spray drying and cyclone separation to obtain 1.41kg of ultrafine non Bacterial sodium carbonate powder (average particle size 15μm).

example 2

[0034] The preparation of example 2 ultrafine aseptic sodium carbonate

[0035]Weigh 1.0kg of anhydrous sodium carbonate, add 5.67 liters of water for injection (30-35° C.) to dissolve, and make a 15% sodium carbonate solution, filter aseptically through a 0.22-micron filter element to obtain a sterile solution of sodium carbonate, and use a clean and dry Sterile air or nitrogen, air inlet temperature 150±5°C, air pressure 0.5MPa, outlet air temperature 85±2°C, solution flow rate 25ml / min, spray drying and cyclone separation to obtain 0.93kg of ultra-fine non-toxic particles with a particle size of 5-15μm Bacterial sodium carbonate powder (average particle size 10μm).

example 3

[0036] The preparation of example 3 ultrafine aseptic sodium carbonate

[0037] Weigh 0.5kg of anhydrous sodium carbonate, add 9.5 liters of water for injection (20-30° C.) to dissolve to make a 5% sodium carbonate solution, filter aseptically through a 0.22-micron filter element to obtain a sterile solution of sodium carbonate, and use a clean and dry Sterile air or nitrogen, air inlet temperature 175±5°C, airflow pressure 0.6MPa, outlet air temperature 88±2°C, solution flow rate 25ml / min spray drying cyclone separation and collection to obtain 0.45kg of ultra-fine powder with a particle size of 1-8μm Bacterial sodium carbonate powder (average particle size 4μm).

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Abstract

The invention relates to medicine composite of superfine sterile sodium carbonate and cephems, which is applied to human medicine for injection and is formed by sterile cephems compound and superfine sterile sodium carbonate with grain size of below 20 Mum. The sterile cephems compound is sterile cefpiramide or sterile ceftazidime, the content of the superfine sterile sodium carbonate in the composite of superfine sterile sodium carbonate and sterile cefpiramide is 13.0-18.0%, and the content of the superfine sterile sodium carbonate in the composite of superfine sterile sodium carbonate and sterile ceftazidime is 8.0-12.0%. The invention has the advantages that when the prepared cefpiramide or ceftazidime powder for injection is clinically used, the prepared cefpiramide or ceftazidime powder for injection can be quickly solved by common transfused liquid medicine, such as 0.9% sodium chloride injection or 5% glucose injection and the like, by a nurse through normal operation even at the low temperature of 10 DEG C so as to be convenient for clinical use.

Description

technical field [0001] The present invention relates to the field of medicine. technical background [0002] Cefpiramide and ceftazidime are third-generation cephalosporins with a broad antibacterial spectrum. They have been widely used in the clinical treatment of bacterial infections with definite curative effects and rare and mild adverse reactions. Cefpiramide is insoluble in water, and ceftazidime is slightly soluble in water. In clinical use, it is dissolved in the form of its salt and administered by intramuscular injection, intravenous injection or intravenous drip. The ceftazidime powder for injection currently on the market has the disadvantage that it is difficult to dissolve with electrolyte solution or glucose solution and other infusions during clinical use; Commonly used infusion solutions have the disadvantage of being difficult to dissolve at low temperatures according to routine operations. [0003] CN100336510C has disclosed composition ratio, pH value, ...

Claims

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Application Information

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IPC IPC(8): A61K47/02A61K31/546A61P31/04
Inventor 谭胜连司徒小燕陈大为
Owner GUANGZHOU BAIYUSN TIANXIN PHARMA
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