湿颗粒法与直接压片生产的盐酸左氧氟沙星薄膜衣片超微结构分析  

Analysis of Ultramicrostructure for Levofloxacin Hydrochloride Film Coated Tablet Produced by Wet Granulation and Direct Compression Tabletting

作　　者：王秀珍[1] 

机构地区：[1]绍兴文理学院,浙江绍兴312000

出　　处：《中国药业》2008年第18期48-49,共2页China Pharmaceuticals

摘　　要：目的考察两种不同方法生产的盐酸左氧氟沙星薄膜衣片的超微结构。方法用电子显微镜观察完全符合国家药品标准的两种盐酸左氧氟沙星薄膜衣片(乐朗与可乐必妥)。结果乐朗的超微结构中可见多种形状、粒径为1～200μm的物质组成的团状混合物,而可乐必妥的超微结构是粒径100nm以下的疏松、细匀颗粒,两者存在巨大差异。结论导致两种片剂的差异原因在于我国传统片剂制备工艺(湿颗粒法)与直接压片工艺的巨大差距,而缩小这个差距的根本是改进我国的传统片剂生产工艺。Objective To investigate the uhramicrostructure of levofloxacin hydrochloride film coated tablet produced by two different technologies. Methods The uhramicrostructure of two sorts of levofloxacin hydrochloride film coated tablet（Lelang and Kelebituo） accorded with the drug standard of our country were observed with electron microscope. Results There were agglomerate composed of substances with many different sorts of shapes and particle sizes from 1 to 200 μm in Lelang uhramicrostructure, but there were loose and uniform fine granules of sixe less than 100 nm in Kelebituo. Conclusion The reason causing the immense difference in uhramicrostructure is due to the difference between the traditional compression technology （wet granulation） and the direct compression technology, and the foundation of reducing the difference is to improve our traditional compression technology.

关 键 词：电子显微镜 超微结构 左氧氟沙星 薄膜衣片 

分 类 号：R917[医药卫生—药物分析学] TQ460.6[医药卫生—药学]