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A kind of anti-infection drug ceftriaxone sodium crystal compound and preparation method thereof

A technology for ceftriaxone sodium and a crystal compound, which is applied in the field of medicine and achieves the effects of good clarity, reduced incidence of adverse reactions and high purity

Active Publication Date: 2018-08-31
SHANDONG LUOXIN PHARMA GRP HENGXIN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

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 indexes are all higher than the pharmacopoeia standard

Method used

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  • A kind of anti-infection drug ceftriaxone sodium crystal compound and preparation method thereof
  • A kind of anti-infection drug ceftriaxone sodium crystal compound and preparation method thereof
  • A kind of anti-infection drug ceftriaxone sodium crystal compound and preparation method thereof

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Experimental program
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Effect test

Embodiment 1

[0043] The preparation of embodiment 1 ceftriaxone sodium crystal compound

[0044] (1) under the sound field that frequency is 30KHz, output power is 50W, with the stirring velocity of 200 rev / mins, ceftriaxone sodium crude product is added into the ethanol that volume is 6 times of ceftriaxone sodium weight, water while stirring. 1. In the mixed solution of ethyl acetate, the volume ratio of ethanol, water, and ethyl acetate is 2.5:4.5:1, the temperature is raised to 35-45°C, and stirred until dissolved;

[0045] (2) With a stirring speed of 200 revs / min, while stirring, adding volume is the mixed solution of ethyl acetate, hexanaphthene which is 3 times of ceftriaxone sodium weight, and the volume ratio of ethyl acetate and hexanaphthene is 3.5: 2.5;

[0046] (3) After adding the mixed solution of ethyl acetate and cyclohexane, under a sound field with a frequency of 20KHz and an output power of 15W, cool down to 0-2°C at 3°C / hour, grow crystals for 3-6 hours, and wash , ...

Embodiment 2

[0053] Determined by thermogravimetric analysis, the results are as follows figure 2 As shown, the crystal water content is 9.53wt%, which is basically consistent with the theoretical value. The preparation of embodiment 2 ceftriaxone sodium crystalline compound

[0054] (1) under the sound field that frequency is 25KHz, output power is 60W, with the stirring velocity of 260 rev / mins, ceftriaxone sodium crude product is added into the ethanol that volume is 5 times of ceftriaxone sodium weight, water while stirring. 1. In the mixed solution of ethyl acetate, the volume ratio of ethanol, water, and ethyl acetate is 2.5:4.5:1, the temperature is raised to 35-45°C, and stirred until dissolved;

[0055] (2) With a stirring speed of 260 revs / min, while stirring, add volume as the mixed solution of ethyl acetate, cyclohexane that ceftriaxone sodium weight 2 times, the volume ratio of ethyl acetate and cyclohexane is 3.5: 2.5;

[0056] (3) After adding the mixed solution of ethyl...

Embodiment 3

[0058] The preparation of embodiment 3 ceftriaxone sodium crystalline compound

[0059] (1) under the sound field that frequency is 25KHz, output power is 40W, with the stirring speed of 150 rev / mins, ceftriaxone sodium crude product is added into the ethanol that volume is 7 times of ceftriaxone sodium weight, water while stirring. 1. In the mixed solution of ethyl acetate, the volume ratio of ethanol, water, and ethyl acetate is 2.5:4.5:1, the temperature is raised to 35-45°C, and stirred until dissolved;

[0060] (2) With a stirring speed of 150 revs / min, while stirring, adding volume is the mixed solution of ethyl acetate, hexanaphthene which is 4 times of ceftriaxone sodium weight, and the volume ratio of ethyl acetate and hexanaphthene is 3.5: 2.5;

[0061] (3) After adding the mixed solution of ethyl acetate and cyclohexane, under a sound field with a frequency of 15KHz and an output power of 10W, cool down to 0-2°C at 4°C / hour, grow crystals for 3-6 hours, and wash ,...

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Abstract

The invention belongs to the technical field of medicines, and discloses an anti-infection medicine ceftriaxone sodium crystal compound and a preparation method thereof. The structural formula of the ceftriaxone sodium crystal compound is represented by formula (I), the crystal compound is detected through X-ray powder diffractometry, and an X-ray powder diffraction pattern represented by 2theta + / - 0.2 DEG C is represented by figure 1. The crystal compound has the advantages of high purity, low polymer content, good stability, difficulty in moisture absorption, and good fluidity. A powder injection produced by directly charging the crystal compound has the advantages of high purity, low impurity content, good clarity, guaranteeing of the packaging efficiency in the production, small filled volume difference, great reduction of the incidence rate of untoward effects, and good stability.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to an anti-infection drug ceftriaxone sodium crystal compound and a preparation method thereof. Background technique [0002] Molecular formula of ceftriaxone sodium: C 18 h 17 N 8 NaO 7 S 3 Triple hemihydrate, the structural formula is as follows: [0003] [0004] The chemical name of ceftriaxone sodium is (6R,7R)-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazine -3-yl)thio]methyl]-7-[[(2-amino-4-thiazolyl)methoxyiminoacetyl]amino]-8-oxo-5-thia-1-aza Bicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt triple hemihydrate. It is white or off-white crystalline powder, odorless and tasteless, hygroscopic, easily soluble in water, slightly soluble in methanol, almost insoluble in chloroform or ether. [0005] Ceftriaxone sodium was developed by Swiss Hoffmann-LaRoche Company and first launched in Switzerland in 1982. Belonging to the third generation of cephalo...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D501/36C07D501/12A61K9/14A61K31/546A61P31/04
CPCA61K9/14A61K31/546C07D501/12C07D501/36
Inventor 李晓峰李俊广吴远芹
Owner SHANDONG LUOXIN PHARMA GRP HENGXIN PHARMA CO LTD
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