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Crystalline compound of drug ceftriaxone sodium for treating surgical operation infections

The technology of a crystal compound, ceftriaxone sodium, is applied in the field of medicine and achieves the effects of good fluidity, high yield and strong repeatability

Inactive Publication Date: 2017-02-22
临沂草之美医药科技有限公司
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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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  • Crystalline compound of drug ceftriaxone sodium for treating surgical operation infections
  • Crystalline compound of drug ceftriaxone sodium for treating surgical operation infections
  • Crystalline compound of drug ceftriaxone sodium for treating surgical operation infections

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] The preparation of embodiment 1 ceftriaxone sodium crystal compound

[0046] (1) Dissolve the crude product of ceftriaxone sodium into a mixed solution of water and carbon tetrachloride whose volume is 8 times the weight of ceftriaxone sodium at 35°C, and the volume ratio of the water and carbon tetrachloride is 4:2.5 ;

[0047] (2) add activated carbon whose weight is 0.2 times of the weight of ceftriaxone sodium for decolorization, filter to obtain ceftriaxone sodium solution;

[0048] (3) Raise the temperature of the ceftriaxone sodium solution to 40°C, and add propyl ether dropwise to the ceftriaxone sodium solution under the condition of stirring. Complete, the stirring rate is 30rmp;

[0049] (4) After the dropwise addition, cool down to -10°C at a rate of 15°C / hour, continue to stir at a stirring rate of 15rmp for 2h, let stand for 3h to precipitate crystals, filter, wash, and vacuum-dry to obtain ceftriaxone sodium crystals.

[0050] determined by powder X-ra...

Embodiment 2

[0053] The preparation of embodiment 2 ceftriaxone sodium crystalline compound

[0054] (1) Dissolve the crude product of ceftriaxone sodium into a mixed solution of water and carbon tetrachloride whose volume is 9 times the weight of ceftriaxone sodium at 35°C, and the volume ratio of the water and carbon tetrachloride is 4:2.5 ;

[0055] (2) adding activated carbon whose weight is 0.3 times of the weight of ceftriaxone sodium for decolorization, and filtering to obtain ceftriaxone sodium solution;

[0056] (3) Raise the temperature of the ceftriaxone sodium solution to 40°C, and add propyl ether dropwise to the ceftriaxone sodium solution under the condition of stirring. Complete, the stirring rate is 30rmp;

[0057] (4) After the dropwise addition, cool down to -10°C at a rate of 15°C / hour, continue to stir at a stirring rate of 15rmp for 2h, let stand for 3h to precipitate crystals, filter, wash, and vacuum-dry to obtain ceftriaxone sodium crystals.

[0058] Measure wit...

Embodiment 3

[0059] The preparation of embodiment 3 ceftriaxone sodium crystalline compound

[0060] (1) Dissolve the crude product of ceftriaxone sodium into a mixed solution of water and carbon tetrachloride whose volume is 10 times the weight of ceftriaxone sodium at 35°C, and the volume ratio of the water and carbon tetrachloride is 4:2.5 ;

[0061] (2) add activated carbon whose weight is 0.4 times of the weight of ceftriaxone sodium for decolorization, and filter to obtain ceftriaxone sodium solution;

[0062] (3) Raise the temperature of the ceftriaxone sodium solution to 40°C, and add propyl ether dropwise to the ceftriaxone sodium solution under the condition of stirring. Complete, the stirring rate is 30rmp;

[0063] (4) After the dropwise addition, cool down to -10°C at a rate of 15°C / hour, continue to stir at a stirring rate of 15rmp for 2h, let stand for 3h to precipitate crystals, filter, wash, and vacuum-dry to obtain ceftriaxone sodium crystals.

[0064] Measure with pow...

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Abstract

The invention belongs to the technical field of medicines and discloses a crystalline compound of a drug, i.e., ceftriaxone sodium for treating surgical operation infections. A structural formula of the crystalline compound of ceftriaxone sodium is represented by a formula (I), the crystalline compound is assayed by powder X-ray diffractometry, and an X-ray atlas powder diffractogram represented by a diffraction angle of 2[theta]+ / -0.2 degree is shown in Figure 1. The crystalline compound is high in purity, low in polymer content, good in stability and good in fluidity and is not prone to moisture absorption. (The formula (I) shown in the description.).

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a crystal compound of ceftriaxone sodium, a medicine for treating surgical infection. 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 ceph...

Claims

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Application Information

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IPC IPC(8): C07D501/36A61K31/546A61P31/00
CPCC07D501/36C07B2200/13
Inventor 李文敏
Owner 临沂草之美医药科技有限公司
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