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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)、Td(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。
In this study, we investigated the release of hydrochlorothiazide (25mg) tablets from two domestic pharmaceutical companies and hydrochloric hydrochlorothiazide (25mg) tablets from Merck Sharp and Dohme Pharmaceutical Factory in artificial gastric juice and artificial intestinal juice by the cycle method and spin-basket method. The results showed that the T_ (50) (time required for 50% release), Td (release 63.2%), and m (slope) in vitro were significantly different by ANOVA. The release of 60% are less than 30 minutes, in line with USP 19 version of the dissolution rate of the provisions of this product.