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Stable cefaclor tablet composition and preparation method thereof

A technology for cefaclor and a composition, which is applied in the field of pharmaceutical compositions and their preparation, can solve the problems of decreased dissolution of cefaclor tablets, increased related substances, decreased content, etc., so as to improve solubility and bioavailability, and ensure product quality quality effect

Active Publication Date: 2014-03-12
SHANGHAI NEW ASIATIC PHARMA MINHANG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But this test condition is to simulate young patients, for elderly patients, the speed of its gastric peristalsis is closer to the rotating speed of 50 revolutions, and under the test conditions of 50 revolutions, the dissolution rate of commercially available cefaclor tablets is significantly decreased trend
[0011] In general, in order to solve the problem of dissolution of insoluble substances, solubilizers such as surfactants are usually added to the prescription. Generally, such surfactants are liquid, and surfactants are usually added to the adhesive. Production is carried out according to the wet granulation process, but since cefaclor is a cephalosporin raw material, the content of cefaclor is likely to decrease and the related substances increase during the wet granulation and drying process, thereby affecting product quality. The solvent is directly applied to the cefaclor tablet

Method used

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  • Stable cefaclor tablet composition and preparation method thereof
  • Stable cefaclor tablet composition and preparation method thereof
  • Stable cefaclor tablet composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Embodiment 1 cefaclor tablet prescription:

[0032]

[0033]

[0034] The preparation process is as follows:

[0035] Such as figure 1 As shown, the cefaclor, microcrystalline cellulose, lactose, and crospovidone were mixed uniformly, the colloidal silicon dioxide was added to diethylene glycol monoethyl ether and stirred evenly while heating, Make it melt, cool and pulverize, pass through a 60-mesh sieve, add cefaclor and prescribed amounts of microcrystalline cellulose, lactose, and crospovidone into a tank mixer, stir for 20 minutes, and dry the mixture The granulator granulates to obtain dry granules, and passes the dry granules through a 16-mesh sieve for granulation. Mix the granules obtained after granulation with the prescribed amount of glyceryl behenate in a V-type mixer for 10 minutes, measure the content of intermediates, determine the weight of the tablets, press them into tablets, and pack the plain tablets to obtain the product.

Embodiment 2

[0036] Embodiment 2 cefaclor tablet prescription:

[0037]

[0038] The preparation process is as follows:

[0039] Such as figure 1 As shown, the cefaclor, microcrystalline cellulose, lactose, and crospovidone are mixed uniformly, colloidal silicon dioxide is added to diethylene glycol monoethyl ether and stirred evenly while heating to make it Melt, cool and pulverize, pass through a 60-mesh sieve, add cefaclor and prescribed amounts of microcrystalline cellulose, lactose, and crospovidone into a tank mixer, stir for 20 minutes, and use a dry granulation mechanism for the mixture Granulate to obtain dry granules, and pass the dry granules through a 16-mesh sieve for granulation. Mix the granules obtained after granulation with the prescribed amount of glyceryl behenate in an elevating mixer for 10 minutes, measure the content of intermediates, determine the weight of the tablets, press them into tablets, and pack the plain tablets to obtain the product.

Embodiment 3

[0040] Embodiment 3 cefaclor tablet prescription:

[0041]

[0042] The preparation process is as follows:

[0043] Such as figure 1 As shown, the cefaclor, microcrystalline cellulose, lactose, and crospovidone are mixed uniformly, colloidal silicon dioxide is added to diethylene glycol monoethyl ether and stirred evenly while heating to make it Melt, cool and pulverize, pass through a 60-mesh sieve, add cefaclor and prescribed amounts of microcrystalline cellulose, lactose, and crospovidone into a tank mixer, stir for 20 minutes, and use a dry granulation mechanism for the mixture Granulate to obtain dry granules, and pass the dry granules through a 16-mesh sieve for granulation. Mix the granules obtained after granulation with the prescribed amount of sodium stearyl fumarate in a V-type mixer for 10 minutes, measure the content of intermediates, determine the weight of the tablet, compress it, and pack the plain tablet to obtain the product.

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Abstract

The invention discloses a cefaclor tablet pharmaceutical tablet composition which comprises cefaclor, lactose, microcrystalline cellulose, crosslinked povidone, diethylene glycol monoethyl ether, colloidal silicon dioxide and glyceryl behenate or sodium stearyl fumarate. The preparation method comprises the following steps: evenly mixing the cefaclor with the pharmaceutical auxiliary materials; adding the colloidal silicon dioxide into the diethylene glycol monoethyl ether, heating while stirring for melting, and cooling to obtain a solid mixture; screening, and evenly mixing the cefaclor auxiliary materials; granulating by a dry process; and after finishing the granules, adding the lubricant, evenly mixing, measuring the intermediate content, determining the tablet weight, tabletting and packaging. The invention provides a legal and reasonable cefaclor table composition and a preparation method thereof, thereby obtaining the cefaclor tablet which has the advantages of stabler and more controllable quality, higher bioavailability and simpler technique.

Description

technical field [0001] The invention relates to a pharmaceutical composition and a preparation method thereof, in particular to a cefaclor tablet composition with high bioavailability and stable quality and a preparation method thereof. Background technique [0002] Cefaclor is a second-generation highly effective oral cephalosporin antibiotic, and its bactericidal effect lies in preventing the synthesis of bacterial cell walls. Compared with commonly used clinical oral cephalosporin antibiotics including cephalexin and cephradine, this product inhibits Gram-negative and positive bacteria including Escherichia coli, influenza bacillus, pneumonia bacillus, Proteus mirabilis, typhoid bacillus, pneumococcus, and Staphylococcus aureus. Strong antibacterial effect. Generally better than cephalexin and cephradine. It is 4-6 times stronger than cephalexin against influenza bacillus and some intestinal bacteria. The stability of β-lactamase varies with the type of enzyme. It is re...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/10A61K9/20A61K31/545A61P31/04
Inventor 曾垂宇王佩芳商鼎
Owner SHANGHAI NEW ASIATIC PHARMA MINHANG
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