Cefaclor film-controlled sustained-release pellets and capsules

Abstract

The invention relates to a cefaclor film-controlled sustained-release pellet capsule, the sustained-release film of the pellet adopts the mixture of water dispersion Eurdragit RL 30D:Eurdragit RS 30D=4:1 (weight ratio) as the film-forming material, the pellet The core contains high-expandability sodium carboxymethyl starch, and the commonly used excipients of pharmaceutically acceptable sustained-release pellets. The excipients are preferably microcrystalline cellulose and lactose, wherein the sodium carboxymethyl starch in the ball core is It accounts for 5-20% of the weight of the ball core. The sustained-release coating film comprises a mixture of water dispersion film-forming materials Eurdragit RL 30D and Eurdragit RS 30D, a plasticizer triethyl citrate and an anti-sticking agent talc, and the ratio is preferably Eurdragit RL 30D: Eurdragit RS 30D: citric acid Triethyl ester: talcum powder = 24:6:2:4, and the coating weight gain is preferably 23-40%. Because the ball core contains sodium carboxymethyl starch, which has high water swelling property, it will swell obviously after absorbing water, resulting in the expansion of the slow-release coating film, the thickness becomes thinner, the pore size of the water-permeable micropores becomes larger, and the permeability becomes better. , which compensates for the decrease in permeability caused by membrane aging, so that the release rate in the middle and late stages is basically constant, and the residue in the end stage is small, which can always maintain a stable release performance within the validity period.

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

Images