Cefuroxime sodium 3/4-hydrate compound

A technology of cefuroxime sodium and furoxin sodium, which is applied in the direction of organic chemistry, organic chemical methods, organic active ingredients, etc., can solve the problems of low thermal decomposition temperature, poor fluidity, and unclearness, and achieve wide application prospects and thermal stability Good performance and fast drying effect

Inactive Publication Date: 2018-12-28
陕西顿斯制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Cefuroxime sodium has poor stability and needs to be sealed and refrigerated at 2-8°C. Improper storage or transportation is prone to solid color deepening. When tested according to pharmacopoeia standards, the color of the solution often fails.
[0006] The cefuroxime sodium product currently used clinically is an anhydrous substance. Due to the influence of the raw material synthesis process and the nature of the drug itself, there are serious problems such as unstable quality, low thermal decomposition temperature, poor fluidity, and easy moisture absorption.
Thereby affecting the product quality, resulting in unclear preparation products, unqualified turbidity, and reducing the stability of the preparation

Method used

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  • Cefuroxime sodium 3/4-hydrate compound
  • Cefuroxime sodium 3/4-hydrate compound
  • Cefuroxime sodium 3/4-hydrate compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031]The preparation of embodiment 1 3 / 4 water cefuroxime sodium compound

[0032] (1) At room temperature, add 852g of cefuroxime acid into 4L of methanol, stir, and slowly add sodium lactate (302g) methylene chloride (604ml) solution to react until the pH value is 6.2;

[0033] (2) Add 4L of ethanol for elution and crystallization, filter, wash with ethanol, and vacuum-dry at 45° C. for 40 minutes to obtain 833 g of cefuroxime sodium 3 / 4 water compound.

[0034] Test results:

[0035] The X-ray diffraction pattern has characteristic diffraction peaks at the diffraction angles 2θ of 10.18°, 11.38°, 13.34°, 19.06°, and 19.25°, and the relative diffraction intensities of the diffraction angles are 100, 20.51, 38.46, 95.47, 93.47, and 10.48;

[0036] Fourier transform infrared spectrum at a wavenumber of 3528.3cm -1 ,3366.2cm -1 , 3257.6cm -1 , 1758.1cm -1 , 1699.0cm -1 , 1667.9cm -1 , 1626.9cm -1 , 1402.0cm -1 , 1333.9cm -1 , 1082.6cm -1 , 1061.8cm -1 , 1011.6cm -...

Embodiment 2

[0038] Preparation of Example 2 3 / 4 Cefuroxime Sodium Compound

[0039] (1) At room temperature, add 732g of cefuroxime acid into 4L of dichloromethane, stir, and slowly add sodium lactate (254g) methanol (317ml) solution to react until the pH value is 6.7;

[0040] (2) Add 4L of acetone for elution and crystallization, filter, wash with ethanol, and vacuum-dry at 45°C for 40min to obtain 781g of cefuroxime sodium 3 / 4 water compound.

[0041] Test results:

[0042] The X-ray diffraction pattern has characteristic diffraction peaks at the diffraction angles 2θ of 10.10°, 11.33°, 13.37°, 19.12°, and 19.28°, and the relative diffraction intensities of the diffraction angles are 100, 21.38, 36.47, 96.14, 92.75, and 11.09;

[0043] Fourier transform infrared spectrum at a wavenumber of 3527.7cm -1 , 3366.4cm -1 , 3258.1cm -1 , 1759.5cm -1 , 1698.6cm -1 , 1667.4cm -1 , 1626.4cm -1 , 1402.2cm -1 , 1333.3cm -1 , 1082.4cm -1 , 1062.0cm -1 , 1012.4cm -1 There are characteri...

Embodiment 3

[0045] The preparation of embodiment 3 3 / 4 water cefuroxime sodium compound

[0046] (1) At room temperature, add 606g of cefuroxime acid into 4L of n-propanol, stir, and slowly add sodium lactate (231g) methanol (385ml) solution to react until the pH value is 6.5;

[0047] (2) Add 3L of ethanol for elution and crystallization, filter, wash with ethanol, and vacuum-dry at 45° C. for 40 minutes to obtain 584 g of cefuroxime sodium 3 / 4 water compound.

[0048] Test results:

[0049] The X-ray diffraction pattern has characteristic diffraction peaks at the diffraction angles 2θ of 10.12°, 11.35°, 13.39°, 19.09°, and 19.30°, and the relative diffraction intensities of the diffraction angles are 100, 21.38, 36.47, 96.14, 92.75, and 11.09;

[0050] Fourier transform infrared spectrum at a wavenumber of 3527.0cm -1 , 3366.1cm -1 , 3258.3cm -1 , 1759.9cm -1 , 1698.2cm -1 , 1667.0cm -1 , 1626.1cm -1 , 1402.5cm -1 , 1333.7cm -1 , 1082.8cm -1 , 1062.2cm -1 , 1012.3cm -1 Ther...

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Abstract

The invention discloses a cefuroxime sodium 3 / 4-hydrate compound and a preparation method. Each mole of cefuroxime sodium 3 / 4-hydrate compound contains 3 / 4 mol of water. The cefuroxime sodium 3 / 4-hydrate compound prepared by using the method is high in stability and meets requirements for raw materials of preparations.

Description

technical field [0001] The invention belongs to the technical field of crystallization of chemical engineering medicines, and in particular relates to a 3 / 4 cefuroxime sodium compound and a preparation method thereof. Background technique [0002] Cefuroxime sodium, English name Cefuroxime Sodium, also known as cefuroxime, cefuroxime, Chinese nickname: (6R, 7R)-7-[2-furyl (methoxyimino) acetamido]-3-aminomethyl Sodium acyloxymethyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate, molecular weight: 446.37, molecular formula: C 16 h 15 N 4 NaO 8 S. [0003] Cefuroxime sodium is white, off-white or light yellow powder or crystalline powder; odorless, bitter taste; hygroscopic, easily soluble in water, slightly soluble in methanol, insoluble in ethanol or chloroform, and contains in every 1ml In a 10 mg solution, the specific rotation is +55° to +65°; the absorbance is measured at a wavelength of 274nm by spectrophotometry, and the absorption coefficient (E1cm1%) is...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/34C07D501/04A61K31/546A61P31/04
CPCC07D501/34C07B2200/13C07D501/04
Inventor 王霞
Owner 陕西顿斯制药有限公司
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