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Ceftizoxime sodium composition sterile powder for injection

A technology of ceftizoxime sodium and sterile powder, which is applied in the field of drug synthesis and preparation, can solve problems such as high cost, inconvenient production operation, and the quality of ceftizoxime sodium does not meet the pharmaceutical standards, so as to reduce production costs and improve the production process. Simple and easy to control, good clinical application effect

Active Publication Date: 2010-09-29
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The crystallization method commonly used in pharmaceutical production is adopted, such as by controlling conditions such as crystallization temperature, solvent drop rate, and stirring speed to improve product quality, increase yield, and improve crystal form, but the production operation is inconvenient and the cost is high. The ceftizole produced The quality of oxime sodium does not meet the pharmaceutical standards

Method used

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  • Ceftizoxime sodium composition sterile powder for injection
  • Ceftizoxime sodium composition sterile powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] [Example 1] Preparation of Crystalline Ceftizoxime Sodium

[0041] At room temperature, put 5g of ceftizoxime sodium into the reactor, add 50ml of water to dissolve, stir for 28 minutes, filter, adjust the pH of the filtrate to 6.3 with glacial acetic acid, control the temperature of the filtrate to 18°C, and Under stirring speed, slowly add dropwise the mixed solution of 200ml dehydrated alcohol and acetone (the volume ratio of dehydrated alcohol and acetone is 1: 2) with the speed of 420ml / h to crystallization, then under the stirring of 30 revolutions per minute , control the supersaturated concentration of the solution, continue to add 200ml ethyl acetate slowly, grow crystals, wash twice with a mixed solution of 50ml absolute ethanol and acetone, drain, and dry under reduced pressure to obtain 4.68g of ceftizoxime sodium in crystalline form .

[0042] Use D / max-IIIA DIFFRATOMETER (RIGAKU CORPORATION, JANPAN) X-diffractometer, measure with Cu, K α 1, λ=1.54056A, th...

Embodiment 2

[0043] [Example 2] Preparation of Crystalline Ceftizoxime Sodium

[0044] At room temperature, drop 5g of ceftizoxime sodium into the reactor, add 50ml of water to dissolve, stir for 28 minutes, filter, adjust the pH of the filtrate to 6.9 with glacial acetic acid, control the temperature of the filtrate to 30°C, and Under stirring speed, slowly add dropwise the mixed solution of 200ml dehydrated alcohol and acetone (the volume ratio of dehydrated alcohol and acetone is 1: 4) with the speed of 480ml / h to crystallization, then under the stirring of 70 revolutions per minute , control the supersaturated concentration of the solution, continue to add 600ml ethyl acetate slowly, grow crystals, wash twice with a mixed solution of 50ml absolute ethanol and acetone, then wash twice with 65ml ethyl acetate, drain, and dry under reduced pressure. 4.67 g of ceftizoxime sodium in crystalline form was obtained.

[0045] The X-ray powder diffraction pattern of the obtained crystalline for...

Embodiment 3

[0046] [Example 3] Preparation of Crystalline Ceftizoxime Sodium

[0047] At room temperature, put 5g of ceftizoxime sodium into the reactor, add 50ml of water to dissolve, stir for 28 minutes, filter, adjust the pH of the filtrate to 6.5 with glacial acetic acid, control the temperature of the filtrate to 25°C, and Under stirring speed, slowly add dropwise the mixed solution of 200ml dehydrated alcohol and acetone (the volume ratio of dehydrated alcohol and acetone is 1: 3) with the speed of 450ml / h to crystallization, then under the stirring of 50 revolutions per minute , control the supersaturated concentration of the solution, continue to add 400ml ethyl acetate slowly, grow crystals, wash twice with 65ml ethyl acetate, drain, and dry under reduced pressure to obtain 4.66g of ceftizoxime sodium in crystalline form.

[0048] The X-ray powder diffraction pattern of the obtained crystalline form of ceftizoxime sodium is consistent with that of Example 1.

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Abstract

The invention relates to ceftizoxime sodium composition sterile powder for injection. The powder contains 99.0 to 99.9 weight percent of ceftizoxime sodium and 0.10 to 1.00 weight percent of sodium benzoate, wherein the ceftizoxime sodium is in a crystallized form. As for the ceftizoxime sodium in the crystallized form, the temperature of solution of ceftizoxime sodium is controlled by adjusting the pH value of the solution and the saturation process of the solution is controlled by a method of adding appropriate amounts of different solvents into the solution in multiple times so as to obtain a ceftizoxime sodium crystal form with uniform grain size distribution. A method for preparing the powder has simple, convenient and easily-controlled production process and low preparation cost and the obtained ceftizoxime sodium in the crystallized form has uniform grain size distribution and is more stable than the ceftizoxime sodium in the market.

Description

technical field [0001] The invention belongs to the field of drug synthesis and preparation, more specifically, the invention relates to a sterile powder of ceftizoxime sodium composition for injection. Background technique [0002] Ceftizoxime sodium (ceftizoxime sodium) was developed by Japan Tengze Pharmaceutical Industry Co., Ltd., and was first listed in Japan in 1982 under the trade name of ceftizox. This product is a third-generation cephalosporin antibiotic with broad-spectrum antibacterial activity and is stable against broad-spectrum lactamase (including penicillinase and cephalosporinase) produced by various Gram-positive and Gram-negative bacteria. This product has a strong antibacterial effect on Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and other Enterobacteriaceae bacteria. Pseudomonas such as Pseudomonas aeruginosa and Acinetobacter are less sensitive to this product. Ceftizoxime has a good antibacterial effect on Haemophilus influenzae and ...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/546C07D501/20A61P31/04
Inventor 李明华张世伟刘延珍
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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