Cefalexin tablet and preparation method thereof

A technology for cephalexin tablets and fadroxil tablets, which is applied in the field of medicinal chemistry, can solve problems such as affecting product quality, complex processes, and non-compliance with quality consistency evaluation requirements, and achieves avoiding the generation of related substances, simple coating process, and production. Easy to operate effect

Active Publication Date: 2015-12-02
NORTH CHINA PHARMA HEBEI HUAMIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The traditional process adopts wet granulation, the process is complicated, and more water will be introduced, while cephalexin belongs to β-lactam antibiotics. Because this type of antibiotics contains β-lactam rings, it is easily affected by heat and humidity, and degradation reactions occur. substances, affecting the quality of the product; and the in vitro dissolution curve of cephalexin tablets produced by the traditional process is not similar to the dissolution curve of the reference preparation, which does not meet the quality consistency evaluation requirements

Method used

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  • Cefalexin tablet and preparation method thereof
  • Cefalexin tablet and preparation method thereof
  • Cefalexin tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] In the present embodiment, each component of cephalexin tablet is as follows:

[0026]

[0027] Prepare as follows:

[0028] 1) Sieve

[0029] Pass the above raw materials of cephalexin, microcrystalline cellulose, sodium carboxymethyl starch, hypromellose and magnesium stearate through an 80-mesh sieve respectively, and collect the powder under the sieve;

[0030] (2) Premix

[0031] Weigh 250 g of cephalexin, 45 g of microcrystalline cellulose, 6 g of sodium carboxymethyl starch, and 17 g of hypromellose after sieving respectively, add them into a mixer, and pre-mix for 10 minutes.

[0032] (3) Dry granulation

[0033] Use a dry granulator to put the mixed material into the feeder, the main pressure: 7-15MPa; the granulation screen: 24 mesh. Conveying speed: 90-220rpm; speed of pressing wheel: 20-45rpm; one screen for whole grain; speed: 10 mesh; 100-150rpm; two screen for whole grain; speed: 24 mesh; 100-150rpm.

[0034] Sieving: The granules are sieved throu...

Embodiment 2

[0042] In the present embodiment, each component of cephalexin tablet is as follows:

[0043]

[0044] Prepare as follows:

[0045] 1) Sieve

[0046] Pass cephalexin, microcrystalline cellulose, sodium carboxymethyl starch, hypromellose, and magnesium stearate through an 80-mesh sieve respectively, and collect the powder under the sieve;

[0047] (2) Premix

[0048] Weigh 250 g of cephalexin, 45 g of microcrystalline cellulose, 7 g of sodium carboxymethyl starch, and 13 g of hypromellose after sieving respectively, add them into a mixer, and pre-mix for 10 minutes.

[0049] (3) Dry granulation

[0050] Use a dry granulator to put the mixed material into the feeder, the main pressure: 7-15MPa; the granulation screen: 24 mesh. Conveying speed: 90-220rpm; speed of pressing wheel: 20-45rpm; one screen for whole grain; speed: 10 mesh; 100-150rpm; two screen for whole grain; speed: 24 mesh; 100-150rpm.

[0051] Sieving: The granules are sieved through a high-efficiency vibra...

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Abstract

The invention discloses a cefalexin tablet and a preparation method thereof. A dry granulating process is adopted, and not only is the degradation of beta-lactam rings achieved, but also the problem of low dissolution of products produced through conventional wet granulation is solved. The product is high in stability, a dissolution curve is similar to that of a reference product, and a production process is simple.

Description

technical field [0001] The invention discloses a cephalexin tablet and a preparation method thereof, belonging to the field of medicinal chemistry. Background technique [0002] Cephalexin (Cephalexin) is a semi-synthetic β-lactam antibiotic with broad-spectrum antibacterial effect on Gram-positive bacteria and Gram-negative bacteria. Its mechanism of action is by inhibiting the synthesis of cell walls, Swell the contents of the cells until they are ruptured and dissolved, thereby achieving a bactericidal effect. [0003] Cefalexin is a semi-synthetic oral cephalosporin antibiotic listed by Eli Lilly and Company in 1970. Its chemical name is (6R,7R)-3-methyl-7-[(R)-2-amino-2-phenylacetamido]- 8-Oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cephalexin tablets were first launched in the United States in October 1972 by Eli Lilly and Company. Due to market reasons, the product has now been removed from the shelves in the United States. At present, there is only ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/545A61P31/04
Inventor 贾玉捷王景欣张锁庆李雪元张文胜杨丹门红乐郑宝丽刘雪飞柳世萍刘海席王朝卿吴士军刘萍牛旻晖李亚卿张剑楠王欠
Owner NORTH CHINA PHARMA HEBEI HUAMIN PHARMA
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