Cefprozil compound, and dispersible tablets, dry suspension and preparation method thereof

A technology of cefprozil and dry suspension, applied in the field of medicine, can solve the problems of decomposition and deterioration, affect the treatment effect of cefprozil, decrease and other problems, and achieve the effect of stable composition, suitability for clinical application and good stability

Active Publication Date: 2014-01-22
金鸿药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because cefprozil is unstable to water and heat, its oral solid preparation will decom...

Method used

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  • Cefprozil compound, and dispersible tablets, dry suspension and preparation method thereof
  • Cefprozil compound, and dispersible tablets, dry suspension and preparation method thereof
  • Cefprozil compound, and dispersible tablets, dry suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Embodiment 1: the preparation of cefprozil compound

[0051] 1. Prepare 5L of a saturated aqueous solution of crude cefprozil at 55°C;

[0052] 2. Prepare 30L of mixed organic solvent of ethanol, ether and ethyl acetate; the volume ratio of ethanol, ether and ethyl acetate in the mixed organic solvent is 4:1:1;

[0053] 3. Cool the organic solvent to 5°C. Under the sound field with a frequency of 25KHz and an output power of 40W, add the saturated aqueous solution of cefprozil crude product to the organic solvent at a constant speed while stirring. The adding speed is 3 liters / hour, and the stirring speed is 1200 rev / min, continue to stir and cool down after the addition, the stirring speed is 360 rev / min, the cooling rate is 1.5°C / hour; stop stirring after cooling down to 0°C, and let the crystal grow for 8 hours; filter after obtaining the crystal, and use Washed with water and ethanol, and dried in vacuum for 4 hours to obtain the cefprozil compound.

[0054] The p...

Embodiment 2

[0055] Embodiment 2: the preparation of cefprozil compound

[0056] 1. Prepare 5 L of saturated aqueous solution of cefprozil crude product at 60°C;

[0057] 2. Prepare 20L of mixed organic solvent of ethanol, ether and ethyl acetate; the volume ratio of ethanol, ether and ethyl acetate in the mixed organic solvent is 5:1:1;

[0058] 3. Cool the organic solvent to 0°C. Under a sound field with a frequency of 25KHz and an output power of 40W, add the saturated aqueous solution of cefprozil crude product to the organic solvent at a constant speed while stirring. The adding speed is 3 liters / hour, and the stirring speed is 600 rpm, continue to stir and cool down after the addition, the stirring speed is 60 rpm, and the cooling rate is 0.5°C / hour; stop stirring after cooling down to 0°C, and let the crystal grow for 6 hours; filter it after obtaining the crystal, and use Washed with water and ethanol, and dried under vacuum for 6 hours to obtain the cefprozil compound.

[0059] ...

Embodiment 3

[0060] Embodiment 3: Cefprozil dispersible tablet (specification 0.125g / tablet)

[0061] Its composition is:

[0062]

[0063] The preparation method is:

[0064] 1. Weigh the cefprozil compound and pharmaceutical adjuvant according to the formula; the cefprozil compound is prepared in Example 1 or 2;

[0065] 2. Sieving: Pass the cefprozil compound, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, and lactose through a 100-mesh sieve respectively;

[0066] 3. Mixing: Add cefprozil compound, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, and neotame into the mixer and mix for 20 minutes, then add sweet orange powdered essence, silicon dioxide, and spray-dried lactose to continue mixing 20 minutes, finally add magnesium stearate and mix for 10 minutes;

[0067] 4. Tablet, pack, and get ready.

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Abstract

The invention relates to the field of medicine, and in particular relates to a cefprozil compound, and dispersible tablets, a dry suspension and a preparation method thereof. The cefprozil compound is a crystal, and an X-ray powder diffraction diagram obtained by Cu-K alpha ray measurement is shown in figure 1. Through experimental detection, the cefprozil dispersible tablets and the dry suspension have the advantages of superior stability and quite good smell and taste, and are quite suitable for clinical application.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a cefprozil compound, its dispersible tablet, dry suspension and a preparation method. Background technique [0002] The molecular formula of cefprozil is: C 18 h 19 N 3 o 5 S·H 2 O, chemical name: (6R,7R)-7-L(R)-2-amino-2-(p-hydroxy-phenyl)acetamido 1-8-oxo-3-propene-5-thia-1 -Azabicyclo-(4,2,0)oct-2-ene-2-carboxylic acid monohydrate, which has the structural formula: [0003] [0004] Cefprozil belongs to the second-generation semi-synthetic cephalosporin antibiotics and is a mixture of cis and trans isomers, of which the cis isomer accounts for about 90% (≥87%). Developed by Bristol-Myers Tokyo Research Institute in 1983, it was first launched in the United States under the trade name of Cefzil in 1991, and then successively launched in more than 20 countries including Canada, Mexico and Sweden. In October 1999, my country's drug regulatory authority approved Sino-US Shanghai...

Claims

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Application Information

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IPC IPC(8): C07D501/22C07D501/12A61K31/545A61K9/16A61K9/20A61P31/04
CPCA61K9/0095A61K9/1623A61K9/1652A61K9/2009A61K9/2054A61K9/2059A61K31/545C07D501/12C07D501/22
Inventor 上官清
Owner 金鸿药业股份有限公司
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