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Ceftriaxone sodium compound and preparation method thereof

A technology of ceftriaxone sodium and ceftriaxone, applied in the field of medicine, can solve the problems of environmental pollution, operator injury, increased production cost, etc., and achieve the effects of improving product quality, simple operation, and reducing the incidence of allergic reactions

Active Publication Date: 2012-08-01
石药集团中诺药业(石家庄)有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] The refining methods of ceftriaxone sodium in the prior art all adopt the method of solvent precipitation, and a large amount of organic solvents need to be used in the production process, which will undoubtedly increase the production cost, pollute the environment, and cause harm to the operator
In addition, the quality level of the ceftriaxone sodium product obtained by the prior art basically meets the pharmacopoeia standard as the goal, or only one index is significantly higher than the pharmacopoeia standard, and fails to reach the level where multiple key quality indicators are higher than the pharmacopoeia standard

Method used

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  • Ceftriaxone sodium compound and preparation method thereof
  • Ceftriaxone sodium compound and preparation method thereof
  • Ceftriaxone sodium compound and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Take 86g of crude ceftriaxone sodium, add 129mL of purified water and stir until the solids are completely dissolved, filter, add potassium chloride to the filtrate, stir, stop adding when crystals are precipitated, add a total of 86g of potassium chloride, and grow crystals at 25°C After 30 minutes, suction filtration, beating and washing with 250 mL of 20% acetone water, and then washing with 200 mL of acetone, draining, and drying in vacuum to obtain 62.1 g of ceftriaxone sodium composition with a yield of 72.2%. The obtained product was tested according to the requirements of the Chinese Pharmacopoeia 2010 edition, and the test results are shown in Table 1.

Embodiment 2

[0046] Take 92g of crude ceftriaxone sodium, add 645mL of water for injection and stir until the solids are completely dissolved, filter, add ammonium sulfate to the filtrate, stir, stop adding when crystals are precipitated, add 13.1g of ammonium sulfate in total, and grow crystals at 15°C for 45 Minutes, suction filtration, beating and washing with 20% acetone water 250mL first, then washing with 200mL acetone, draining, and vacuum drying to obtain 73.2g of ceftriaxone sodium composition, with a yield of 79.6%. The obtained product was tested according to the requirements of the Chinese Pharmacopoeia 2010 edition, and the test results are shown in Table 1.

Embodiment 3

[0048] Take 75g of crude ceftriaxone sodium, add 225mL of purified water and stir until the solids are completely dissolved, add potassium nitrate, stir, stop adding when crystals are precipitated, add a total of 12.5g of potassium nitrate, grow crystals at 5°C for 5 minutes, and filter with suction , first beating and washing with 20% acetone water 250mL, then washing with 200mL acetone, draining, and vacuum drying to obtain 60.9g of ceftriaxone sodium composition, with a yield of 81.2%. The obtained product was tested according to the requirements of the Chinese Pharmacopoeia 2010 edition, and the test results are shown in Table 1.

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Abstract

The invention relates to a ceftriaxone sodium compound and a preparation method thereof. The compound comprises active ingredient ceftriaxone sodium, impurities and ceftriaxone polymer, wherein the content of ceftriaxone sodium is not less than 90.0% by calculation on the basis of an anhydride, the total weight percent of the impurities is not larger than 0.1% on the basis of the weight percent of ceftriaxone, the impurities comprise 7-ACT and triazine ring, and the weight percent of the ceftriaxone polymer is not larger than 0.1% on the basis of the weight percent of ceftriaxone. The preparation method of the compound is simple, economical and environment-friendly, the contents of the impurities and the polymer in a product are low, adverse reactions are remarkably reduced, and safety of clinical medication of a ceftriaxone sodium preparation can be guaranteed well.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a cephalosporin antibacterial drug composition and a preparation method thereof, in particular to a ceftriaxone sodium composition and a preparation method thereof. Background technique [0002] Ceftriaxone sodium belongs to the third generation of cephalosporins for injection. It is researched and developed by Roche, Switzerland. Its chemical name is (6R, 7R)-7-[[(2-amino-4-thiazolyl) Amino)acetyl]amino]-8-oxo-3-[[(1,2,5,6-tetrahydro-2methyl-5,6-dioxo-1,2,4-triazine-3 -yl)thio]methyl]-5-thio-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid disodium salt triple hemihydrate, its structural formula is as follows. [0003] . [0004] Ceftriaxone sodium is a semi-synthetic cephalosporin, which exerts antibacterial effect by inhibiting the synthesis of bacterial cell walls, and has strong antibacterial activity against most Gram-positive bacteria and Gram-negative ba...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/36C07D501/12A61K31/546A61P31/04
Inventor 卢华姚兵郝金恒安志强齐雁鸿徐永龙袁军才戚桂君张晓燕
Owner 石药集团中诺药业(石家庄)有限公司
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