利迈先片的生物利用度测定（The first piece of determination of Lima biological）.docVIP

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利迈先片的生物利用度测定（The first piece of determination of Lima biological）.doc

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利迈先片的生物利用度测定（The first piece of determination of Lima biological）

利迈先片的生物利用度测定（The first piece of determination of Lima biological） The first piece of determination of Lima biological Update: 2011-08-06 Click: Limaixian research group CLC number: R927.1, document identification code: B Article number:(2000) -[Limaixian (clarithromycin) (Clarithromycin, CLM)] is a new kind of macrolide antibiotics, chemical name is 6 - O - methyl erythromycin A, by 6 the erythromycin molecule hydroxyl and methoxy substituted by. This change makes the structure of CLM compared with erythromycin, acid stability, good oral absorption, high concentration in plasma and tissue, improve the degree of utilization of biomass, eliminate half-life, broad antibacterial spectrum, so the treatment of clinical infection curative effect. The serum concentration of CLM in healthy volunteers were determined by microbiological method, preparation and import klacid on Limaixian and 2 manufacturers of bioequivalence evaluation. 1 materials and methods 1.1 instrument and reagent DG 2A multi-function incubator (Shanghai medical instrument factory); phosphate buffer (pH6.0, prepared by the China Pharmacopoeia edition of 1995); m.luteus (9341) (Shanghai Institute for drug control; provide) medium II (pH8.0) (Kangle medium limited company); control (clarithromycin provided by the Hainan longnate Pharmaceutical Co. Ltd; (98.7%) the content of Limaixian production by Xian pharmaceutical factory, 250mg/, No. 9905167); klacid (produced by ABBOTT company, 250mg/, batch 44012TF). 1.2 volunteer selection There were 8 male healthy volunteers, ranging from 22a to 25A, with an average (23 + 1.07) a, weight 58kg to 83kg, mean (66.8 + 8.36) kg, height 165cm to 175cm, mean (170.8 + 3.84) cm. All volunteers had normal liver and kidney function before the trial, and the subjects signed voluntary protocols and applied to the Ethics Committee for clinical pharmacological bases for approval. 1.3 drug delivery methods and sample collection 8 volunteers were randomly divide