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Cefetamet pivoxil hydrochloride hydrate crystals and dispersible tablet thereof

A technology of ceftamet pivoxil hydrochloride and hydrate, which is applied in the field of ceftamet pivoxil hydrochloride hydrate crystals and its dispersible tablets, and can solve the problem of easy moisture absorption and deterioration of loading, variance, poor stability and fluidity of ceftamet pivoxil hydrochloride and other problems, to achieve the effect of good crystal stability, high bioavailability, and not easy to absorb moisture

Active Publication Date: 2015-09-02
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Ceftazidime pivoxil hydrochloride has poor stability and fluidity, is easy to absorb moisture and deteriorate, and there is a difference in loading

Method used

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  • Cefetamet pivoxil hydrochloride hydrate crystals and dispersible tablet thereof
  • Cefetamet pivoxil hydrochloride hydrate crystals and dispersible tablet thereof
  • Cefetamet pivoxil hydrochloride hydrate crystals and dispersible tablet thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Get ceftazidime pivoxil hydrochloride crude product crude drug 10g and dissolve it in 30ml of ethanol at a temperature of 5°C, add ceftazidime pivoxil hydrochloride crude product quality 0.1 gac to decolorize for 20-30 minutes, filter, and wash with a small amount of ethanol solution to obtain ceftazidime hydrochloride Decolorize the ceftazidime pivoxil hydrochloride ethanol solution with activated carbon for 20 minutes, filter, and wash with a small amount of ethanol solution to obtain the ethanol solution of ceftazidime pivoxil hydrochloride. Add 200ml of saturated sodium chloride solution at a temperature of -15°C dropwise to the memethicone ethanol solution at a constant speed, and the dropwise addition is completed within 0.5 hours at a constant speed. Leave for 4 hours to precipitate pale yellow crystals, filter, wash with distilled water and ethyl acetate successively, and then vacuum-dry to obtain 9.78 g of ceftazidime hydrochloride hydrate crystals.

[0040]Det...

Embodiment 2

[0048] Dissolve 10 g of the crude ceftazidime hydrochloride crude drug in 50 ml of ethanol at a temperature of 10°C, add activated carbon with a crude quality of 0.02 for ceftazidime hydrochloride to decolorize for 30 minutes, filter, and wash with a small amount of ethanol solution to obtain ceftazidime hydrochloride Ethanol solution, the ethanol solution of ceftazidime hydrochloride was heated to 30 °C, and 350 ml of saturated sodium chloride solution with a temperature of -10 °C was added dropwise to the ethanolic solution of ceftazidime hydrochloride at a stirring rate of 23 rmp for 0.5 h. The dropwise addition was completed at a constant speed. After the dropwise addition was completed, the temperature was lowered to -10 °C and the stirring was continued for 1 h at a stirring speed of 12 rmp. After standing for 2 h, light yellow crystals were precipitated. 9.89 g of crystals of US ester hydrate.

[0049] Determined by powder X-ray diffractometry, the X-ray powder diffract...

Embodiment 3

[0053] Dissolve 10 g of the crude ceftazidime hydrochloride crude drug in 80 ml of ethanol at a temperature of 8 °C, add activated carbon with a crude quality of 0.1 ceftazidime hydrochloride to decolorize for 25 minutes, filter, and wash with a small amount of ethanol solution to obtain ceftazidime hydrochloride Ethanol solution, the ethanol solution of ceftazidime hydrochloride was heated to 25 °C, and 500 ml of saturated sodium chloride solution at a temperature of -5 °C was added dropwise to the ethanolic solution of ceftazidime hydrochloride at a stirring rate of 25 rmp for 0.5 h. The dropwise addition was completed at a constant speed. After the dropwise addition was completed, the temperature was lowered to -10°C and the stirring was continued for 2 hours at a stirring rate of 15 rpm. After standing for 4 hours, light yellow crystals were precipitated. 9.83 g of US ester hydrate crystals.

[0054] Determined by powder X-ray diffractometry, the X-ray powder diffraction p...

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Abstract

The invention provides a cefetamet pivoxil hydrochloride hydrate, wherein an X-ray powder diffraction spectrogram obtained by measurement by using Cu-Kalpha rays is represented by the figure 1. Cefetamet pivoxil hydrochloride hydrate crystals disclosed by the invention are good in stability, difficult to absorb moisture and good in mobility and can be uniformly mixed with other accessories; and a prepared cefetamet pivoxil hydrochloride dispersible table is rapid in absorption speed and high in bioavailability.

Description

technical field [0001] The invention belongs to the field of medicine, in particular to a ceftazidime hydrochloride hydrate crystal and a dispersible tablet thereof. Background technique [0002] In the prior art, β-lactam antibiotics are the most clinically used antibiotics, the most widely used, the most varieties, the best curative effect and the highest evaluation. Among them, cephalosporin series products account for about 70%. Among cephalosporins, ceftazidime pivoxil hydrochloride is an oral third-generation broad-spectrum cephalosporin antibiotic, which has the characteristics of broad-spectrum, high efficiency, enzyme resistance, and low toxicity. Compared with similar varieties of cephalexin and cephradine, it has antibacterial With the advantages of stronger activity and smaller dose, it overcomes the shortcomings of Pioneer series products that are unstable to β-lactamase, and is an ideal substitute for cephalexin and cephradine. [0003] Ceftazidime hydrochlori...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/22C07D501/12A61K31/546A61K9/20A61P31/04
CPCC07D501/12C07D501/22
Inventor 朱绪辉赵海松徐太平王华孟凡磊
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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