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口服单剂量地尔硫卓缓释胶囊的人体相对生物利用度研究
引用本文:代宗顺,顾世芬,侯淑贤,邵春丽,吴力,艾永循. 口服单剂量地尔硫卓缓释胶囊的人体相对生物利用度研究[J]. 沈阳药科大学学报, 2000, 17(1): 19-22
作者姓名:代宗顺  顾世芬  侯淑贤  邵春丽  吴力  艾永循
作者单位:1. 同济医科大学临床药理研究所,武汉,430030
2. 同济医科大学基础医学院药理教研室,武汉,430030
3. 武汉市职工医学院,武汉,430016
摘    要: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.

关 键 词:地尔硫卓  缓释胶囊  生物利用度  药代动力学  高效液相色谱
修稿时间:1999-04-15

Relative Bioavailability of Diltiazem Sustained-release Capsules after Administration of the Single Oral Dose to Healthy Volunteers
Dai Zongshun,Gu Shifen,Hou Shuxian,Shao Chunli,Wu Li,Ai Yongxun. Relative Bioavailability of Diltiazem Sustained-release Capsules after Administration of the Single Oral Dose to Healthy Volunteers[J]. Journal of Shenyang Pharmaceutical University, 2000, 17(1): 19-22
Authors:Dai Zongshun  Gu Shifen  Hou Shuxian  Shao Chunli  Wu Li  Ai Yongxun
Abstract:This article introduces the study on bioavailability of diltiazem between the tested sustained-release capsules(SRC)(made in Wuhan)and control SRC(made in France),which was carried out in 12 healthy volunteers at the oral dose by the cross-over method.A new analytical method was established for determining the plasma diltiazem concentration using HPLC.The results indicated that both maximal plasma concentration( C max )of two kinds of SRC were(68.85±19 00)ng/mL and(69 01±22 45)ng/mL,respectively;Tmax of two kinds of SRC were(4 58±1 37)h and(4 69±2 10)h,respectively,and the AUC of two kinds of SRC were(1541 6±535 9)ng/mL·h and(1562 2±649 0)ng/mL·h,respectively.In conclusion,the relative bioavailability of the diltiazem SRC of Wuhan was(98 58±16 98)%.Through the equivalent analysis,the two kinds of SRC were bioequivalence.
Keywords:diltiazem  sustained-release capsule  bioavailability  pharmacokinetic  HPLC
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