北京大学学报(医学版)2001,Vol.33Issue(3):224-227,4.
溶蚀分散型盐酸地尔硫卓艹脉冲控释片的体内外研究
In vitro and in vivo studies on pulsatile release ta blets of
diltiazem hydrochloride of the erosion-dispersion type
摘要
Abstract
Objective: To investigate the preparation of pulsatile release tablets, the release of the drug in vitro and the pharmacokinetics in vivo . Methods: Dil tiazem hydrochloride(DIL) was used as model drug. The pulsatile release tabl e ts were prepared by dry-coated method with carnauba wax, bee wax and hydrophil i c cellulose as coating materials. The effects of formulation and technology on t he release characteri stic of diltiazem hydrochloride was investigated. The mechanism of pulsatile rel ease of the drug was proved by erosion test. The pharmacokinetic study on four h uman subjects was done by means of HPLC measurement. Results: In vitro , delayed-release ti me t 10 was 2.1 h, the maximum release time t rm 4.0 h and t he pulsed-releas e time t 10-90 1.7 h. In vivo , delayed-release time t la g was 5.7 h, the p eak time 8.5 h and the pulsed-release time 2.6 h. Conclusion: The rele ase of drug from pulsatile-released tablets of diltiazem hydrochloride was in a pulsed way both in vitro and in vivo .关键词
地尔硫/化学合成/地尔硫/药代动力学/剂型分类
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范田园,严文伟,魏树礼,丁武孝..溶蚀分散型盐酸地尔硫卓艹脉冲控释片的体内外研究[J].北京大学学报(医学版),2001,33(3):224-227,4.