一种米格列奈钙缓释微丸及其制备方法

Mitiglinide calcium sustained-release pellets and preparation method thereof

Abstract

<b>本发明公开了</b><b>一种米格列奈钙缓释微丸及其制作方法,包括</b><b>包衣层、含药微丸;</b><b>尤特奇NE30D,滑石粉,十二烷基硫酸钠或聚乙二醇</b><b>;</b><b>米格列奈钙,空白丸芯,填充剂,润滑剂,粘合剂。</b><b>本发明采用的比较新颖的缓释制剂和微丸制剂,缓释是指通过延缓药物从该剂型中的释药速率,降低药物进入机体的吸收速率,从而起到更加稳定的治疗效果;微丸具有药物在胃肠道表面分布面积增大,可减少刺激性,提高生物利用度,同时不受胃排空因素影响,药物体内吸收均匀,个体差异小;两种先进的技术同时应用更加增强了本药的技术优势。与口服液相比,具有药物稳定性好,包装,运输,贮藏方便等优点,其制备方法简单易行,适用于工业生产。</b>
The invention discloses mitiglinide calcium sustained-release pellets and a preparation method thereof. The mitiglinide calcium sustained-release pellets comprise a coating layer, drug-containing pellets, Eudragit NE 30D, powdered steatile, sodium dodecyl sulfate or polyethylene glycol, mitiglinide calcium, blank-pellets, a filler, a lubricant, and an adhesive. According to the invention, a novel sustained-release preparation and a pellets preparation are employed, sustained release means that by prolonging drug release rate of a drug in a dosage form, the absorption rate of the drug in human body is reduced, so that more stable treatment effect can be realized; the pellets have the advantage of large distribution area of the drug on surface of gastrointestinal tract, reduce irritation, increase bioavailability, and do not be influenced by gastric emptying influence, the drug can be uniformly absorbed by human body, individual difference is little; simultaneous application of two advanced technologies enhances the technical advantage of the mitiglinide calcium sustained-release pellets; compared with oral liquid, the mitiglinide calcium sustained-release pellets have the advantages of good drug stability, convenient package, transport and storage, the preparation method is simple and easy to operate, and is suitable for industrial production.

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