Cefalexin capsules and preparation method

A technology of cephalexin capsules and cephalexin, applied in capsule delivery, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problems of unstable dissolution of cephalexin capsules and poor product fluidity, and improve fluidity and dissolution Unstable problems, improvement of fluidity, effect of ensuring product quality

Inactive Publication Date: 2019-12-27
长春迪瑞制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to achieve the above object, the present invention provides a kind of cephalexin capsule, whic

Method used

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  • Cefalexin capsules and preparation method
  • Cefalexin capsules and preparation method
  • Cefalexin capsules and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] A preparation method of cephalexin capsules comprises:

[0039] Step S1, pre-mixing: put 90.6% of cephalexin, 7.9% of microcrystalline cellulose, and 1.0% of carmellose sodium (here is weight percentage) into the three-dimensional motion mixer, and set the frequency of the three-dimensional motion mixer to 10Hz , mixed for 16 minutes;

[0040] Step S2, granulation: add the above mixed medicinal powder into a dry granulator for dry granulation; the parameters of the granulator are: stirring speed 25rpm, screw speed 80rpm, pressure roller speed 16rpm, pressure roller gap 1.1mm, granulation speed 80rpm , Roller pressure 120bar, sieve size 1.0mm, vacuum 0.1bar;

[0041]Step S3, batch mixing: add the above granules and 0.5% magnesium stearate into a three-dimensional motion mixer, and mix for 10 minutes at a frequency of 10 Hz;

[0042] Step S4, capsule filling: put the above mixed powder into a capsule filling machine to fill capsules.

Embodiment 2

[0044] The microcrystalline cellulose in Step S1 of Example 1 was replaced by dextrin, the sodium carmellose was replaced by methyl cellulose, the magnesium stearate in Step S3 was replaced by stearic acid, and the rest remained unchanged.

Embodiment 3

[0046] The microcrystalline cellulose in step S1 of Example 1 was replaced with sorbitol, the sodium carmellose was replaced with hydroxypropyl cellulose, the magnesium stearate in step S3 was replaced with talcum powder, and the rest remained unchanged.

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Abstract

The invention discloses cefalexin capsules and a preparation method. The capsules comprise the following components in percentage: 90.6% of cefalexin, 6.4-8.3% of microcrystalline cellulose, 0.6-1.6%of carboxymethyl cellulose sodium and 0.5-1.4% of magnesium stearate, wherein the sum of weight percentages of the components is 100%. The preparation process of the capsules comprises the following steps: performing pre-mixing for 16 minutes at a frequency of 10Hz, performing pelletizing, performing batch mixing for 10 minutes at a frequency of 10Hz, and performing capsule filling, wherein pelletizing conditions are that the stirring speed is 25rpm, the spiral rotation speed is 55-85rpm, the rotation speed of rollers is 16rpm, the gap of the rollers is 0.9-1.3mm, the rotation speed of granuleshaping is 80rpm, the pressure of the rollers is 100-130bar, the aperture of a granule shaping mesh size is 1.0mm, and the vacuum degree is 0.1bar. The flowability and the dissolution stability of the capsules disclosed by the invention can be improved, and the method for preparing the capsules is low in energy consumption and green and environment-friendly.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a cephalexin capsule and a preparation method thereof. Background technique [0002] Bacterial infection is the most common and most frequent infectious disease and complication clinically, endangering human health, and the treatment mainly relies on antibiotics. Cefalexin is the first generation of cephalosporin antibiotics that can be taken orally. In my country, it is mainly used for acute tonsillitis, angina, bronchitis, pneumonia and other respiratory tract infections, urinary tract infections and skin and soft tissue infections caused by sensitive bacteria. Wait. Cefalexin (Cefalexin, namely cephalexin IV) is a β-lactam antibiotic, which inhibits the synthesis of the cell wall and causes the cell contents to swell to burst and dissolve, thereby achieving a bactericidal effect. [0003] Cefalexin is an oral cephalosporin antibiotic developed by the America...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/38A61K31/545A61P31/04
CPCA61K9/1652A61K31/545A61P31/04
Inventor 孙佳欣黄玉芬王立华
Owner 长春迪瑞制药有限公司
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