地红霉素肠溶颗粒及制备工艺制造技术

本发明专利技术公开了一种地红霉素肠溶颗粒及其制备方法，本发明专利技术肠溶颗粒的原料组成为：地红霉素、微晶纤维素、４％羟丙甲纤维素溶液、尤特奇Ｌ３０Ｄ－５５、柠檬酸三乙酯、滑石粉。在制备过程中采用转动制粒机法（亦称离心制粒机法），在粉末性物料中加入一定量的粘合剂，在转动、摇动、搅拌等作用下使粉末结聚成具有一定强度的球形粒子，本工艺与传统工艺相比较工序少、省时、操作方便、可控性好，所得颗粒圆整、密实，得到的本发明专利技术地红霉素肠溶颗粒样品质量稳定，释放性质可以达到《中国药典》（２０００年版）的有关规定和临床用药品标准。

Enteric coated granules of erythromycin and preparation process thereof

The invention discloses a dirithromycin enteric coated granule and preparation method of the invention, enteric coated granules raw materials: erythromycin, microcrystalline cellulose, 4% hydroxypropyl methylcellulose solution, Eudragit L30D 55, citric acid three acetate, talcum powder. In the preparation process of the rotary granulating machine method (also known as centrifugal granulating method), adding a certain amount of binder in powder material, in turn, shaking, stirring the powder blended into spherical particles with certain strength, this process compared with the traditional process, the process is less time-saving and convenient operation and good controllability, the particle roundness, compacting, samples of the invention has stable quality of dirithromycin enteric granule obtained, release properties can reach the \China Pharmacopoeia\ (2000 EDITION) with the relevant provisions of the pharmaceutical standards and clinical.

【技术实现步骤摘要】

【技术保护点】
一种地红霉素肠溶颗粒，其特征在于该肠溶颗粒的原料组成为：　地红霉素　２００－３００重量份　微晶纤维素　３００－７００重量份　４％羟丙甲纤维素溶液　１５０－２５０重量份　尤特奇Ｌ３０Ｄ－５５　４００－５００重量 份　柠檬酸三乙酯　５－１５重量份　滑石粉　３０－７０重量份。

【技术特征摘要】

【专利技术属性】
技术研发人员：何晶，
申请(专利权)人：何晶，
类型：发明
国别省市：66[中国|海南]