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High-purity ceftazidime powder injection and preparation method thereof

A ceftazidime, high-purity technology, applied in the field of high-purity ceftazidime powder injection and preparation thereof, can solve the problems of not being able to obtain ceftazidime and the like

Active Publication Date: 2016-05-11
GUANGZHOU HC PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this method is helpful to improve the product purity, according to this method, even if the common ceftazidime in the market is refined more than 10 times by this method, the ceftazidime with a purity of more than 99.5% cannot be obtained

Method used

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  • High-purity ceftazidime powder injection and preparation method thereof
  • High-purity ceftazidime powder injection and preparation method thereof
  • High-purity ceftazidime powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Activated carbon (Egret A type) (its specific surface 1020m 2 / g, pore volume 0.60ml / g, average pore diameter 2.35nm) 200 grams are suspended in 1000 milliliters of water, stir, filter in the cylindrical funnel that diameter is 5cm, rinse gac with 1500 milliliters of water, vacuum-dry, form diameter is Cylindrical filter with 5cm activated carbon filter layer.

[0057] 50 g of ceftazidime circulating in the market was added to 100 ml of water, and 2N sodium hydroxide solution was added dropwise to dissolve it to obtain an aqueous solution of ceftazime, the pH of which was 6.3 to 7.0. Slowly add the above ceftazidime solution to the filter of the activated carbon filter layer, and add it in about 15 minutes. It was then eluted with 500 ml of water. Accept the filtrate, discard the first 100ml of filtrate, start collecting when the concentration of the filtrate reaches 30mg / L, control the flow rate at 4-5mL / min, stop collecting when the concentration of the filtrate is ...

Embodiment 2

[0067] Activated carbon (ENO activated carbon (its specific surface 1430m 2 / g, pore volume 1.17ml / g, average pore diameter 3.27nm) mixed with Egret A activated carbon 1:1) 300 grams suspended in 1000 milliliters of water, stirred, filtered into a cylindrical funnel with a diameter of 5 cm, with 2000 milliliters of water Rinse the activated carbon and vacuum dry to form a cylindrical filter with a diameter of 5 cm activated carbon filter layer.

[0068]50 grams of ceftazidime circulating in the market were added to 150 milliliters of water, and triethylamine was added dropwise to dissolve it to obtain an aqueous solution of ceftazidime, the pH of which was 5.5 to 6.0. Slowly add the above ceftazidime solution to the cylindrical filter of the activated carbon filter layer, and add it in about 20 minutes. It was then eluted with 500 ml of water. Accept the filtrate and discard the first 100 ml of filtrate. Then start to receive 450 ml of filtrate.

[0069] Adjust the tempera...

Embodiment 3

[0082] Preparation of ceftazidime powder injection

[0083] 9 kg of ceftazidime sterile powder bulk drug obtained by the method described in Example 1 and 1 kg of sodium carbonate sterile powder were mixed uniformly, and then packed to obtain sterile powder injection, specification 2.0 g / bottle.

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Abstract

The invention belongs to the field of medicinal chemistry, and particularly relates to a high-purity ceftazidime powder injection and a preparation method thereof. The high-purity ceftazidime powder injection can have the dosage of 0.5g, 1g or 2g, and contains ceftazidime crude drug, wherein in the ceftazidime crude drug, the content of ceftazidime with the structural formula (I) is 99.70-99.95wt%, the content of impurity pyridine is 0.001-0.05wt%, the content of impurity ceftazidime polymer is 0.001-0.05wt%, the content of impurity ceftazidime methyl ester is lower than 0.05wt%, and the total content of other impurities is 0.03-0.30wt%. The high-purity ceftazidime powder injection has extremely high stability, high safety and high antibacterial activity, and the lifetime thereof is longer than that of existing ceftazidime powder injection by 50% or above. Furthermore, the preparation method of the high-purity ceftazidime powder injection, provided by the invention, is easy and convenient to operate, low in cost and high in safety.

Description

technical field [0001] The invention belongs to the field of medicinal chemistry, and more specifically relates to a high-purity ceftazidime powder injection and a preparation method thereof. Background technique [0002] Ceftazidime is a third-generation cephalosporin widely used clinically. It was developed by the British Glaxo Company in 1984. Ceftazidime has a broad antibacterial spectrum and is effective against most Gram-positive and Gram-negative bacteria. For example, it has high antibacterial activity against Enterobacteriaceae such as Escherichia coli and Klebsiella pneumoniae and Haemophilus influenzae and Pseudomonas aeruginosa; it also has good antibacterial activity against nitrate-negative bacilli and Alcaligenes; pneumococcus , Hemolytic Streptococcus and other Gram-positive cocci are highly sensitive to this product. However, this product is only moderately active against staphylococci, and enterococci and methicillin-resistant staphylococci are often resi...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/546C07D501/46C07D501/12A61P31/04
Inventor 冯彩云
Owner GUANGZHOU HC PHARM CO LTD
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