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Ceflazidime powder preparation for injection

A technology of ceftazidime and ceftazidime dihydrochloride, which is applied in the field of ceftazidime powder for injection, can solve the problems of many impurities, low purity of active ingredients, obvious side effects, etc., and achieve less residual solvent, less impurities and high stability. Effect

Active Publication Date: 2015-06-03
NORTH CHINA PHARMA HEBEI HUAMIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, some methods for preparing ceftazidime preparations have been disclosed at home and abroad, but the ceftazidime preparations made by these methods have problems such as low purity of active ingredients, too many impurities, and obvious side effects caused thereby.

Method used

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  • Ceflazidime powder preparation for injection
  • Ceflazidime powder preparation for injection
  • Ceflazidime powder preparation for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] (1) At 5°C to 10°C, weigh 150g of ceftazidime dihydrochloride raw material, add 550ml of distilled water, stir to dissolve, cool down to 0°C to 5°C, slowly add 20% sodium hydroxide solution dropwise to adjust the pH to 5.0 ±0.2, add 11g of activated carbon, filter after 30 minutes of decolorization, wash the filter residue and filter bottle with water twice, and the filtrate enters the crystallization bottle.

[0028] (2) At 10°C to 20°C, with a stirring speed of 300 revolutions / min, add hydrochloric acid at the flow acceleration rate shown in the table below:

[0029] time (min)

Drop rate(ml / min)

[0030] 0-10

0.32

10-40

0

40-60

0.6

60-80

1.0

80-110

1.6

110-140

2.1

140-180

0

[0031] (3) suction filtration, wash the filter cake 2 times with 20ml water and acetone respectively, put the filter cake in a vacuum drying oven, the temperature of the vacuum drying oven i...

Embodiment 2

[0034] (1) At 5°C-10°C, weigh 150g of ceftazidime dihydrochloride raw material, add 550ml of distilled water, stir to dissolve, cool down to 0°C-5°C, slowly add ammonia solution dropwise to adjust the pH to 5.0±0.2, add activated carbon 11g, decolorized for 30 minutes and then filtered, washed the filter residue and the filter bottle twice with water, and the filtrate was put into the crystallization bottle.

[0035] (2) At 10°C to 20°C, with a stirring speed of 280 rpm, add 15% phosphoric acid at the flow acceleration rate in the following table:

[0036] time (min)

Drop rate(ml / min)

0-10

0.31

10-40

0

40-60

0.61

60-80

1.0

80-110

1.61

110-140

2.1

140-180

0

[0037] (3) suction filtration, wash the filter cake 2 times with 20ml water and acetone respectively, put the filter cake in a vacuum drying oven, the temperature of the vacuum drying oven is at 40°C, vacuum dry and weigh to ob...

Embodiment 3

[0040] (1) At 5°C-10°C, weigh 150g of ceftazime dihydrochloride raw material, add 550ml of distilled water, stir to dissolve, cool down to 0°C-5°C, slowly add 15% sodium bicarbonate solution dropwise to adjust the pH to 5.0± 0.2, add 11g of activated carbon, filter after 30 minutes of decolorization, wash the filter residue and filter bottle with water twice, and the filtrate enters the crystallization bottle.

[0041] (2) At 10°C to 20°C, with a stirring speed of 280 revolutions / min, add 10% sulfuric acid at the flow acceleration rate in the following table:

[0042] time (min)

Drop rate(ml / min)

0-10

0.33

10-40

0

40-60

0.62

60-80

1.01

80-110

1.6

110-140

2.11

140-180

0

[0043] (3) suction filtration, wash the filter cake 2 times with 20ml water and acetone respectively, put the filter cake in a vacuum drying oven, the temperature of the vacuum drying oven is at 40°C, vacuum dry an...

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Abstract

The invention discloses a ceflazidime powder preparation for injection. The ceflazidime powder preparation is prepared by the steps as follows: (1), a raw material ceflazidime dihydrochloride is weighed at the temperature ranging from 5 DEG C to 10 DEG C, distilled water is added, the raw material is stirred to be dissolved, is cooled and is dropwise added with alkaline agent to adjust pH (potential of hydrogen), activated carbon is added, and filtering and washing are performed after decoloration; (2), Hebei Huamin pharmacy limited liability company affiliated to North China pharmaceutical group corporation adopts molecular assembly and morphology optimization techniques of crystal products in the particle process, the stirring speed is 250-300 turns per minute at the temperature ranging from 10 DEG C to 20 DEG C, and acid is added according to a flow acceleration table, so that pH is adjusted; (3), suction filtration, washing, vacuum drying, weighing and sub-packaging are performed; (4), ceflazidime pentahydrate and arginine or sodium carbonate are subjected to powder mixing in a certain weight proportion, environment temperature and humidity are controlled after powder mixing, and sub-packaging of the sterile preparation is performed. The ceflazidime prepared with the preparation method has the advantages of few impurities, high stability and the like.

Description

technical field [0001] The invention relates to a ceftazidime powder preparation for injection, which belongs to the technical field of medicine. Background technique [0002] Ceftazidime pentahydrate, the chemical name is (6R,7R)-7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-(1-hydroxy-2-methyl Base-1-oxopropan-2-yl)oxyiminoacetyl]amino]-8-oxo-3-(pyridin-1-ium-1-ylmethyl)-5-thia-1-aza Bicyclo[4.2.0]oct-2-ene-2-carboxylic acid, the structural formula is as follows: [0003] [0004] Ceftazidime is a third-generation cephalosporin antibiotic created by GlaxoSmithKline, which has a strong effect on Gram-positive or negative bacteria. Pseudomonas aeruginosa, Escherichia coli, Klebsiella, Proteus, Enterococcus, Salmonella, Shigella, Neisseria gonorrhoeae, Neisseria meningitidis, Staphylococcus aureus, hemolytic streptococcus, pneumococcus and other Aerobacter has strong antibacterial activity, especially for Pseudomonas aeruginosa, ceftazidime is the most effective antibiotic, a...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/546
Inventor 刘树林董伟昌蒋晓声张锁庆胡少华贾全王智张文胜李敏姜莉莉傅翠连
Owner NORTH CHINA PHARMA HEBEI HUAMIN PHARMA
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