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曲克芦丁溶出度测定条件的优选和体外溶出的比较 被引量:2

Optimization of dissolution determination condition and comparison of in vitro dissolution behaviors of troxerutin tablets
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摘要 目的建立曲克芦丁片的溶出度试验方法,对5厂家生产的曲克芦丁片的含量和溶出度进行测定。方法对该片剂的溶出度测定的基本条件进行筛选,用紫外分光光度法测定含量,测定波长为349nm,并对溶出参数进行了统计学处理。结果以纯化水为溶出介质,转速为125 r·min-1,60 min取样为测定该片剂的最佳测定条件,各厂家曲克芦丁片的溶出参数(t50、td、m)差异有高度统计学意义(P<0.01)。结论5厂家生产的曲克芦丁片的溶出行为明显不一致,进行溶出度检查有助于控制质量。 AIM To establish a dissolution determination method for troxerutin tablets, and to determine the content and vitro dissolution of troxerutin tablets produced from 5 factories. METHODS The best conditions were selected through experiment, the content was measured by UV spectrophotometry at 349 nm, the dissolutive parameters of different products were processed with statistical analytics. RESULTS An ideal determining condition from experiments was got: releasing medium was purified water, rotational speed was 125 r·min^-1 and sampling time was 60min. The dissolution parameters( t50, td, re)of troxerutin tablets from different manufactures had very significant difference( P 〈 0.01 ). CONCLUSION The dissolution rate of troxerutin tablets from different manufactures are remarkably different, dissolution measurement is helpful for controlling the quality.
出处 《中国临床药学杂志》 CAS 2006年第3期185-187,共3页 Chinese Journal of Clinical Pharmacy
关键词 曲克芦丁 含量测定 溶出度 troxerutin content determination dissolution
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  • 1江苏省卫生厅药政局编.江苏省药品标准[S].南京:江苏省科技出版社,1984.107.
  • 2中国药品生物制品检定所编.中国药品检验标准操作规范[S].北京:人民卫生出版社,2000.50-55.

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