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氢氯噻嗪片释放度的研究

Dissolution Rate of Hydrochlorothiazide Tablets

  • 摘要: 本课题用循环法和转篮法研究了国内两个药厂的氢氯噻嗪(25mg)片与美国 Merck Sharp and Dohme 药厂的氢氯噻嗪(25 mg)片在人工胃液及人工肠液中的释放度。结果表明:三个药厂的片剂体外释放参数 T_(50)(释放50%所需的时间)、T_d(释放63.2%)所需的时间及 m(斜率)经方差分析有显著性差异。而释放60%均小于30分钟,符合 USP 19版对本品溶解速率的规定。

     

    Abstract: The dissolution rate of three brands of hydrochlorothiazide tablets was studied in simulated gastric and intestinal medium by using basket and circulating flow methods. The tablets used were two brands of home-made tablets (25 mg) and Merck Sharp and Dohme tablets ( 25 mg). The results showed that the parameters of T_(50),T_d, and m (slop) of tablets were significant difference statistically (P<0.01), but for the time of releasing 60% of hydrochlorothiazide, all three brands of tablets were less than 30 min., this dissolution rate meets the specification of USP XIX

     

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