Cefaclor film-controlled slow-release pellet capsule

Abstract

The invention relates to a cefaclor film-controlled slow-release pellet capsule. A slow-release film of the cefaclor film-controlled slow-release pellet utilizes a mixture of aqueous dispersion Eurdragit RL 30D and Eurdragit RS 30D as a film-formation material, wherein a weight ratio of Eurdragit RL 30D to Eurdragit RS 30D in the mixture is 4: 1. A pellet core of the cefaclor film-controlled slow-release pellet contains sodium carboxymethyl starch having high expansibility, and also contains pharmaceutically-acceptable common excipients for the slow-release pellet, wherein preferably, the excipients comprise microcrystalline cellulose and lactose, and the pellet core comprises 5 to 20wt% of the sodium carboxymethyl starch. The slow-release film comprises the mixture of Eurdragit RL 30D and Eurdragit RS 30D, triethyl citrate as a plasticizer, and talcum powder as an antiplastering aid, wherein preferably, a ratio of Eurdragit RL 30D to Eurdragit RS 30D to triethyl citrate to talcum powder is 24: 6: 2: 4 and a film weight increasing ratio is in a range of 23 to 40%. The cefaclor film-controlled slow-release pellet comprises the pellet core containing sodium carboxymethyl starch having high water expansibility and thus after absorbing water, the cefaclor film-controlled slow-release pellet obviously expands so that the slow-release film is stretched; the thickness of the slow-release film is reduced; the water-permeable micropore size is increased; and permeability is improved and the permeability reduction caused by film aging is counteracted. Therefore, in middle and later stages, the cefaclor film-controlled slow-release pellet release rate is basically constant; in the last stage, residues are less; and stable release performances can be kept in the period of validity.

Description

technical field [0001] The invention relates to a cefaclor membrane-controlled sustained-release pellet capsule, in particular to a cefaclor membrane-controlled sustained-release pellet capsule whose core contains sodium carboxymethyl starch, belonging to the field of pharmaceutical preparations. Background technique [0002] Cefaclor is a cephalosporin antibiotic, which plays an antibacterial effect by inhibiting the synthesis of bacterial cell walls and has bactericidal properties. It can quickly sterilize bacteria at low concentrations, and is used for respiratory system, urinary system, otolaryngology, skin and soft tissue infections caused by sensitive bacteria. [0003] Cefaclor is slightly soluble in water, and the earliest common preparation on the market needs to be taken 3 times a day, the blood concentration fluctuates greatly, the peak concentration is too high, and the adverse reactions are serious. [0004] Cefaclor Sustained Release Tablets (trade name: Cefac...

AI Technical Summary

Problems solved by technology

[0008] In order to solve the problem of release decline caused by film aging of cefaclor film-controlled sustained-release pellets prepared by water dispersion coating, the present invention provides a film-controlled film-controlled pellet that can maintain stable release performance throughout the validity period. Cefaclor sustained-release pellet capsules are characterized in that the core of the pellets contains sodium carboxymethyl starch with high water-swellability, and the sustained-release coating film is deformed by water swelling, thereby offsetting the aging of the film

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