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Cefoxitin sodium crystalline compound

A technology for cefoxitin sodium and a compound, applied in the field of medicine, can solve the problems of not meeting the requirements of cefoxitin sodium for normal temperature preservation, not giving inspection data and the like

Inactive Publication Date: 2018-06-29
BEIJING RED SUN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

But above-mentioned crystal form all can not satisfy the requirement that cefoxitin sodium is stored at room temperature in the whole shelf life (24 months).
The master's thesis of Hebei University of Science and Technology "Synthesis and Stability of Cefoxitin Sodium" provides a synthetic method. The cefoxitin sodium crystals prepared by this method can be stored at 25°C±2°C and relative humidity of 60%±10%. It is relatively stable under storage, but the inspection data of the whole shelf life (24 months) is not given

Method used

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  • Cefoxitin sodium crystalline compound

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Embodiment 1

[0030] Embodiment 1: Cefoxitin sodium crystal form compound

[0031] Take 50 g of crude cefoxitin sodium and add it to 100 mL of water, heat and stir until it is completely dissolved to obtain an aqueous solution of cefoxitin sodium, then add 5 g of activated carbon, stir for 30 minutes, filter while it is hot, control the filtrate at 85 ° C, and slowly Add dropwise a mixed solution of absolute ethanol and methanol, the volume ratio of the mixed solution absolute ethanol to methanol is 12:1, until the solution appears turbid, stir to room temperature, continue to stir for 30 minutes, stand overnight, filter, and dry Obtained as white powdery crystals. The purity was 99.4% by HPLC.

[0032] The X-ray powder diffraction pattern obtained by measuring the cefoxitin sodium crystal form compound obtained using Cu-Kα rays is as follows: figure 1 shown.

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Abstract

The invention belongs to the technical field of medicine and particularly relates to a cefoxitin sodium crystalline compound shown as formula (I) in the description. An X-ray powder diffraction pattern of the compound under measurement with Cu-Kalpha rays is shown as figure 1. The cefoxitin sodium crystalline compound has better stability and can be stored at room temperature, and storage cost andtransport cost of the drug are reduced effectively.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a crystal form compound of cefoxitin sodium and a preparation method thereof. Background technique [0002] The chemical name of Cefoxitin Sodium is: (6R,7S)-3-(carbamoyloxymethyl)-7-methoxy-8-oxo-7-[2(2-thienyl) Acetylamino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt. Its chemical structural formula is: [0003] [0004] Cefoxitin Sodium is a brand-new cephalosporin antibiotic drug developed by Merck & Co. of the United States, which was introduced into the Chinese market in 1992. The product has a broad antibacterial spectrum, strong activity against Gram-positive bacteria, negative bacteria, anaerobic bacteria or aerobic bacteria, highly stable to β-lactamase, wide distribution in the body, and drug in the exudate of infection It has the characteristics of high concentration, and because it is mainly excreted by the kidneys, it has sma...

Claims

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Application Information

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IPC IPC(8): C07D501/57C07D501/12A61K31/546A61P31/04
CPCC07B2200/13C07D501/12C07D501/57
Inventor 林德良
Owner BEIJING RED SUN PHARMA
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