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Cefetamet pivoxil hydrochloride crystal form II and preparation method thereof

A technology of ceftazidime pivoxil hydrochloride and its crystal form, which is applied in the field of pharmaceuticals, can solve the problems of unreported compound solid-state form data, unmentioned compound crystal form research, etc., achieve good medicinal value and development prospects, and good medicinal development value, mild effect

Inactive Publication Date: 2015-10-14
CHENGDU BRILLIANT PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the existing literature, there is no mention of the crystal form of the compound, nor any solid state data of the compound

Method used

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  • Cefetamet pivoxil hydrochloride crystal form II and preparation method thereof
  • Cefetamet pivoxil hydrochloride crystal form II and preparation method thereof
  • Cefetamet pivoxil hydrochloride crystal form II and preparation method thereof

Examples

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Effect test

Embodiment 1

[0025] A crystal form II of ceftamet pivoxil hydrochloride, the preparation method of which comprises the following steps:

[0026] (1) 100 g of crude ceftazidime hydrochloride with a purity of 98.5% was fully dissolved with 300 mL of methanol at room temperature to obtain ceftazidime hydrochloride solution;

[0027] (2) Add 1500g of water to the ceftazidime pivoxil hydrochloride solution obtained in step (1), crystallize at room temperature, filter after crystallization while stirring for 5h, and air-dry at room temperature for 5h to obtain the crystal form of ceftazime pivoxil hydrochloride II 81.5g, the yield is 81.5%, and its purity is 99.6% as detected by HPLC.

[0028] The X-ray powder diffraction pattern and DSC-TGA pattern of the crystal form II of ceftazime pivoxil hydrochloride prepared are shown in the accompanying drawings.

[0029] Stability determination: the prepared crystalline form II of ceftamet pivoxil hydrochloride was vacuum-dried at 60°C for 24 hours, an...

Embodiment 2

[0032] A crystal form II of ceftamet pivoxil hydrochloride, the preparation method of which comprises the following steps:

[0033] (1) 50 g of crude ceftazidime hydrochloride with a purity of 98.5% was fully dissolved with 100 mL of methanol at room temperature to obtain ceftazidime hydrochloride solution;

[0034] (2) add 500g water in the ceftazidime pivoxil hydrochloride solution that step (1) obtains, crystallization, room temperature crystallization, filter after the crystallization 5h while stirring, room temperature blast drying 5h, obtain ceftazime pivoxil hydrochloride The crystal form II was 43.2g, the yield was 86.4%, and its purity was 99.5% as determined by HPLC.

[0035] The X-ray powder diffraction pattern and DSC-TGA pattern of the crystal form II of ceftazime pivoxil hydrochloride prepared are shown in the accompanying drawings.

[0036] Stability determination: the prepared crystalline form II of ceftamet pivoxil hydrochloride was vacuum-dried at 60°C for 2...

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Abstract

The invention discloses a cefetamet pivoxil hydrochloride crystal form II. The X-ray powder diffractogram of the crystal form II measured by Cu-Kalpha rays has characteristic absorption peaks when 2theta is 4.8+ / -0.2 degrees, 7.3+ / -0.2 degrees, 11.7+ / -0.2 degrees, 12.4+ / -0.2 degrees, 14.6+ / -0.2 degrees, 19.0+ / -0.2 degrees, 22.2+ / -0.2 degrees and 24.6+ / -0.2 degrees. The preparation method comprises the following steps: (1) dissolving cefetamet pivoxil hydrochloride in an organic solvent in a weight ratio of 1:(1-5); and (2) adding water or a poor solvent, crystallizing at room temperature for 3-8 hours, filtering, and carrying out forced air drying at room temperature for 5-6 hours to obtain the cefetamet pivoxil hydrochloride crystal form II. The preparation method is simple, has the advantages of mild conditions and low cost, and can be performed at room temperature; and the prepared product has high yield and high purity (up to 99.5% or above), and has favorable pharmaceutical development value.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and in particular relates to a crystal form II of ceftamet pivoxil hydrochloride and a preparation method thereof. Background technique [0002] Cefetame Pivoxil Hydrochloride (Cefetame Pivoxil Hydrochloride), the chemical name is (6R, 7R)-3-methyl-7-[(Z)-2-(2-amino-4-thiazolyl)-2-(methoxy Imino)-acetylamino]-8-oxo-5-thia-1-azabicyclo[4,2,0]oct-2-ene-2-carboxylic acid pivaloyloxymethyl ester hydrochloride, molecular formula :C 20 h 25 N 5 o 7 S 2 ·HCl, molecular weight: 548.04, structural formula as follows: [0003] [0004] Ceftazidime pivoxil hydrochloride was developed by Roche (Ro15-8075), developed by Takeda Pharmaceutical Company of Japan, and organized a nationwide research in Japan in 1987. It was first listed in Mexico in 1992, listed in Japan in 1993, and launched in China in 1997. Successful domestic development. [0005] Ceftazidime pivoxil hydrochloride itself has no or ...

Claims

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Application Information

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IPC IPC(8): C07D501/22C07D501/12
CPCC07D501/22C07B2200/13C07D501/12
Inventor 唐云黄浩喜李晓东李英富苏忠海
Owner CHENGDU BRILLIANT PHARMA CO LTD
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