最近美国药物食品管理局(FDA)对氯噻嗪片提出生物等效性的要求。作者对两家药厂生产的6批氯噻嗪片(250mg和500mg各3批)进行体内生物利用度试验,并结合体外崩解度和溶出速率试验进行研究。体外试验:按美国药典第19版规定,测定6批片剂 Recently, the U.S. Food and Drug Administration (FDA) proposed the bioequivalence requirement for chlorothiazide tablets. The authors tested the in vivo bioavailability of 6 batches of chlorothiazide tablets (250 mg and 500 mg each) produced by two pharmaceutical companies and studied the in vitro disintegration and dissolution rate tests. In Vitro Test: Six batches of tablets are tested according to the 19th edition of the U.S. Pharmacopeia