Cefaclor sustained release tablet and preparation method thereof

A technology of cefaclor and sustained-release tablets, which is applied in the field of medicine, can solve problems such as complicated procedures, increased humidity and unstable impurities, etc., and achieve the effects of simple process, good product stability and excellent sustained-release performance

Active Publication Date: 2021-08-03
GUANGZHOU BAIYUNSHAN PHARMA HLDG CO LTD BAIYUNSHAN PHARMA GENERAL FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Invention concept: The present invention uses polyoxyethylene water-soluble resin as the skeleton material, cooperates with enteric-coated blocker, and adopts direct compression technology to prepare cefaclor sustained-release tablets, which can avoid the damp heat caused by traditional wet granulation and tablet compression. The increase of unstable impurities also improves the problem of complicated procedures in dry granulation

Method used

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  • Cefaclor sustained release tablet and preparation method thereof
  • Cefaclor sustained release tablet and preparation method thereof
  • Cefaclor sustained release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] A cefaclor sustained-release tablet, comprising an inner core and a coating, the inner core includes the following components:

[0037]

[0038] Film-forming material: hypromellose (stomach-soluble coating solution).

[0039] Its preparation method is as follows:

[0040] Weigh the prescription amount of raw and auxiliary materials, sieve them separately, mix in a mixer for 60 minutes, and set aside; set the pressure of the tablet press to 6kN, and the speed to 12 rpm, and perform tablet compression to obtain plain tablets. The obtained plain tablets are prepared with 60% ethanol solution to prepare a stomach-soluble coating liquid, and coated, and the weight of the finished product increases by 3% after coating.

Embodiment 2

[0042] A cefaclor sustained-release tablet, comprising an inner core and a coating, the inner core includes the following components:

[0043]

[0044] Film-forming material: hydroxypropyl cellulose (stomach-soluble coating solution).

[0045] Its preparation method is as follows:

[0046] Weigh the raw and auxiliary materials of the prescribed amount, sieve them separately, mix them in a mixer for 40 minutes, and set aside; set the pressure of the tablet press to 15kN, and the rotation speed to 10 rpm, and perform tablet compression to obtain plain tablets. The obtained plain tablets are prepared with 60% ethanol solution to prepare a stomach-soluble coating liquid, and coated, and the weight of the finished product increases by 3% after coating.

Embodiment 3

[0048] A cefaclor sustained-release tablet, comprising an inner core and a coating, the inner core includes the following components:

[0049]

[0050] Film-forming material: polyvinylpyrrolidone (stomach-soluble coating solution).

[0051] Its preparation method is as follows:

[0052] Weigh the prescription amount of raw and auxiliary materials, sieve respectively, mix in a mixer for 40 minutes, and set aside; set the pressure of the tablet press to 6kN, and the rotating speed to 15 rpm, and perform tablet compression to obtain plain tablets. The obtained plain tablets are prepared with 60% ethanol solution to prepare a stomach-soluble coating liquid, and coated, and the weight of the finished product increases by 3% after coating.

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Abstract

The invention belongs to the technical field of medicines, and discloses a cefaclor sustained release tablet and a preparation method thereof. The cefaclor sustained release tablet comprises an inner core and a coating, the inner core comprises cefaclor, polyoxyethylene water-soluble resin and an enteric retardant, and the mass of the polyoxyethylene water-soluble resin accounts for 15.0%-30.0% of the mass of the inner core. According to the invention, the polyoxyethylene water-soluble resin is used as a framework material and is matched with the enteric retardant, and the mass ratio of the polyoxyethylene water-soluble resin is controlled, so that the prepared sustained release tablet is constant in drug release, excellent in sustained release performance and good in product stability, and few impurities are generated in a finished product in a lofting process. The cefaclor sustained release tablet provided by the invention is few in raw material composition and free of a lubricant and is few in preparation steps, simple in process, easy to operate and suitable for industrial mass production by adopting a direct tabletting mode.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a cefaclor sustained-release tablet and a preparation method thereof. Background technique [0002] Cefaclor is a second-generation oral cephalosporin, which has a strong killing effect on a variety of Gram-positive and Gram-negative bacteria, and is mainly used for the treatment of respiratory tract infections, urinary tract infections, gonorrhea infections, Otitis media and other diseases. The dosage form of cefaclor at present has multiple dosage forms such as tablet, capsule, granule, sustained-release pellet, sustained-release tablet and dispersible tablet. [0003] Common preparations of cefaclor are generally taken three times a day, and the number of times of taking is too many, which brings inconvenience to patients. Cefaclor sustained-release tablets just make up for this defect, not only maintaining its original antibacterial properties, but also reducing...

Claims

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Application Information

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Patent Type & AuthorityApplications(China)
IPC IPC(8): A61K9/36A61K9/32A61K9/22A61K31/545A61K47/10A61K47/38A61K47/32A61P31/04
CPCA61K31/545A61K9/2031A61K9/2054A61K9/2027A61K9/2866A61K9/284A61K9/2095A61P31/04
Inventor王玮王健松陶婵娟黄海文钟莹
OwnerGUANGZHOU BAIYUNSHAN PHARMA HLDG CO LTD BAIYUNSHAN PHARMA GENERAL FACTORY