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目的 以盐酸地尔硫 艹卓 普通片为参比制剂 ,研究盐酸地尔硫 艹卓 控释胶囊的药代动力学性质和相对生物利用度。方法 采用自身对照法 ,健康志愿受试者分别单剂量和多剂量口服盐酸地尔硫 艹卓 控释胶囊与普通片 ,采用反相高效液相色谱法测定地尔硫 艹卓 血药浓度变化情况 ,3P87药代动力学程序进行处理。结果 单剂量po 6 0mg盐酸地尔硫 艹卓 控释胶囊与普通片的AUC0→τ分别为 (6 37.5 6± 10 6 .18)h·μg·L- 1 和 (5 97.39± 117.6 0 )h·μg·L- 1 ,cmax 分别为 (5 9.5± 8.0 ) μg·L- 1 和 (99.7± 8.2 ) μg·L- 1 ,tmax分别为 (4 .5± 0 .5 )h和 (3.0± 0 .3)h ,t1 2 分别为 (5 .9± 1.1)h和 (5 .3± 0 .7)h ,相对生物利用度为 (10 6 .39± 12 .5 3) %。多剂量po盐酸地尔硫 艹卓 控释胶囊 (每次 6 0mg ,每日 2次 )与盐酸地尔硫 艹卓 普通片每次 30mg ,每日 3次达稳态后 ,AUC0→τ分别为 (6 2 0 .35± 73.75 )h·μg·L- 1 和 (30 3.90± 5 4.5 3)h·μg·L- 1 ,cssmax分别是 (79.0± 7.6 ) μg·L- 1 与 (73.3± 12 .6 ) μg·L- 1 ,cssmin分别是(33.1± 5 .5 ) μg·L- 1 与 (2 3.9± 5 .7) μg·L- 1 , css分别为 (5 1.7± 6 .2 ) μg·L- 1 和 (38.0± 6 .8) μg·L- 1 ,tmax分别为 (3.4±
OBJECTIVE To study the pharmacokinetics and relative bioavailability of diltiazem hydrochloride controlled release capsules with Diltiazem Hydrochloride as reference preparation. Methods By self-control method, healthy volunteers were treated with oral and multiple doses of diltiazem hydrochloride controlled-release capsules and normal tablets respectively, and the change of diltiazem concentration in plasma was determined by RP-HPLC , 3P87 Pharmacokinetics program for processing. Results The AUC0 → τ of single dose po 60 mg Diltiazem hydrochloride controlled release capsules and conventional tablets were (6 37.5 6 ± 10 6 .18) h · μg · L -1 and (5 97.39 ± 117.6 0) h respectively · Μg · L- 1 and cmax were (5 9.5 ± 8.0) μg · L- 1 and (99.7 ± 8.2) μg · L- 1, respectively 0. 3) h, t1 2 were (5.9 ± 1.1) h and (5.3 ± 0.7) h, respectively, and the relative bioavailability was (106.39 ± 12.53)%. Multi-dose po Diltiazem hydrochloride controlled release capsules (each 60mg, 2 times daily) and diltiazem hydrochloride tablets each 30mg, 3 times a day steady state, AUC0 → τ were (6 20.35 ± 73.75) h · μg · L -1 and (30 3.90 ± 5 4.5 3) h · μg · L -1, respectively, and the values of cssmax were (79.0 ± 7.6) μg · L -1 and (73.3 ± 12.6) μg · L-1, and cssmin were (33.1 ± 5.5) μg · L-1 and (2.39 ± 5.7) μg · L-1, respectively ) μg · L-1 and (38.0 ± 6 .8) μg · L-1, respectively. The tmax was (3.4 ±)