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１２ 名男性健康志愿受试者，随机交叉一次口服法国进口的盐酸地尔硫卓缓释胶囊（ 参比品） 和国产的盐酸地尔硫卓缓释胶囊（ 试验品） 各１８０ ｍｇ，进行人体生物利用度研究，血药浓度用ＨＰＬＣ 法测定．２ 种盐酸地尔硫卓缓释胶囊，其药时曲线和药代动力学特征十分相似．参比品和试验品从胃肠吸收均有较短的滞后时间．其Ｃｍａｘ 分别为（６８－８５ ±１９－００）ｎｇ／ｍＬ 和（６９－０１ ±２２－４５）ｎｇ／ｍＬ，Ｔｍａｘ 分别为（４－５８ ±１－３７）ｈ 和（４－６９ ±２－１０）ｈ ，ＡＵＣ（０ ～３６） 分别为（１５４１－６ ±５３５－９）ｎｇ／ｍＬ·ｈ 和（１ ５６２ ±６４９－２）ｎｇ／ｍＬ·ｈ ，试验品盐酸地尔硫卓缓释胶囊的相对生物利用度（９８－５９ ±１６－９８） ％ ，试验品与参比品的ＡＵＣ（０ ～３６） ，经方差分析，２ 者的吸收程度具有生物等效性．
Twelve male healthy volunteers were randomly assigned to oral administration of diltiazem hydrochloride sustained-release capsules (reference) and domestic diltiazem hydrochloride sustained-release capsules (test) 180 mg each for oral bioavailability, blood Drug concentration was determined by HPLC method. Two kinds of diltiazem hydrochloride sustained-release capsules, the drug curve and pharmacokinetic characteristics are very similar. Reference and test samples absorbed from the gastrointestinal tract have a shorter lag time. The C max were (68-85 ± 19-00) ng / mL and (69-01 ± 22-45) ng / mL, respectively, with Tmax values of (4-58 ± 1-37) h and (4-69 ± 2 -10) h and AUC (0-36) were (1541-6 ± 535-9) ng / mL · h and (1562 ± 649-2) ng / mL · h, respectively. The test substance, diltiazem hydrochloride sustained release capsules Relative bioavailability (98-59 ± 16-98)%, AUC (0 ~ 36) of the test and reference products, by the analysis of variance, the degree of absorption of the two bioequivalence.