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８名健康者，随机交叉口服两种单剂量（３０ｍｇ）地尔硫普通片后，利用ＨＰＬＣ法测定血浆中地尔硫，其药代动力学过程均符合二室开放模型，消除半衰期分别为３．６±３．５和４．７±１．８ｈ。分别在３．１±０．４和３．１±０．２ｈ达到峰值１１８．５±１４．３和１１３．０±３２．０μｇ／Ｌ，血药浓度曲线下面积分别为７９３．１±８３．１和７４７．５±１２１．５μｇ·ｈ·Ｌ－１。８名健康者，随机交叉口服两种多剂量（每次３０ｍｇ，８ｈ一次）地尔硫普通片后，测得两种片剂稳态时的Ｃｍａｘ分别为８５．４±１９．８和９１．１±２８．４μｇ／Ｌ，Ｃｍｉｎ分别为３０．７±９．２和２９．０±７．７μｇ／Ｌ。两者的血药浓度波动系数ＦＩ分别为０．９１±０．４０和１．００±０．２９。经双单侧Ｔ检验法检验，两种片剂具有生物等效性。
Eight healthy volunteers were randomized to receive two single doses (30 mg) of diltiazem tablets randomly. Plasma Diltiazem was determined by HPLC. The pharmacokinetics of Diltiazem were in accordance with the two-compartment open model and the elimination half-lives 3.6 ± 3.5 and 4.7 ± 1.8h. Respectively reached peak values of 118.5 ± 14.3 and 113.0 ± 32.0μg / L at 3.1 ± 0.4 and 3.1 ± 0.2h respectively, and the area under the plasma concentration curve was 793.1 ± 83 .1 and 747.5 ± 121.5μg · h · L-1.8 healthy persons were randomized to two oral administration of multiple doses (once every 30mg, 8h once) diltiazem common tablets, the two tablets were measured The Cmax was 85.4 ± 19.8 and 91.1 ± 28.4 μg / L, respectively, at steady state, with Cmin of 30.7 ± 9.2 and 29.0 ± 7.7 μg / L, respectively. The plasma concentration fluctuation coefficients FI of the two were 0.91 ± 0.40 and 1.00 ± 0.29, respectively. Tested by double-sided T test, the two tablets have bioequivalence.