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| 多潘立酮片人体生物等效性研究 | |
| 引用本文： | 吴婷,张军,储继红,许美娟,居文政,周玲,谈恒山. 多潘立酮片人体生物等效性研究[J]. 中国药物与临床, 2011, 11(6): 638-640 |
| 作者姓名： | 吴婷 张军 储继红 许美娟 居文政 周玲 谈恒山 |
| 作者单位： | 1. 南京中医药大学附属医院临床药理科,210029 2. 南京中医药大学药学院 3. 南京军区总医院临床药理科 |
| 基金项目： | 江苏省中医药领军人才培养资助项目 |
| 摘 要： | 目的用高效液相色谱-质谱联用法(LC-MS/MS)测定受试者口服多潘立酮制剂后的血药浓度,估算受试制剂和参比制剂的药代动力学参数,评价2种制剂的生物等效性和相对生物利用度。方法采用随机二交叉设计试验,24例男性健康志愿受试者,单剂量口服受试制剂和参比制剂多潘立酮片。以LC-MS/MS测定血浆中多潘立酮的浓度。采用BAPP3.0软件处理计算主要药动学参数。结果受试制剂和参比制剂血浆中多潘立酮的半衰期(t1/2)分别为(10.2±1.9)和(10.2±2.2)h;达峰浓度(Cmax)分别为(26±11)和(25±12)μg/L,达峰时间(tmax)分别为(0.7±0.5)和(0.6±0.3)h;药-时曲线下面积(AUC0～36h)分别为(75±24)和(70±27)μg·h-1·L-1;AUC0-∞分别为(80±26)和(74±28)μg·h-1·L-1;人体相对生物利用度为(114±30)%。结论 2种制剂在健康人体内具有生物等效性。 |
| 关 键 词： | 多潘立酮 药代动力学 治疗等效 碎片质谱法 |
Bioequivalence study of domperidone tablets in healthy Chinese volunteers |
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| WU Ting,ZHANG Jun,CHU Ji-hong,XU Mei-juan,JU Wen-zheng,ZHOU Ling,TAN Heng-shan. Bioequivalence study of domperidone tablets in healthy Chinese volunteers[J]. Chinese Remedies & Clinics, 2011, 11(6): 638-640 | |
| Authors: | WU Ting ZHANG Jun CHU Ji-hong XU Mei-juan JU Wen-zheng ZHOU Ling TAN Heng-shan |
| Affiliation: | WU Ting,ZHANG Jun,CHU Jihong,XU Mei-juan,JU Wen-zheng,ZHOU Ling,TAN Heng-shan.Department of Clinical Pharmacology,Affiliated Hospital of Nanjing University of Traditional Chinese Medicine,Nanjing 210029,China |
| Abstract: | Objective To evaluate the relative bioequivalence of two domperidone preparations in healthy Chinese volunteers by estimated pharmacokinetics based on plasma concentrations of the drugs detected by LC-MS/MS.Methods A single oral dose of two preparations was given to 24 healthy male volunteers according to a randomized crossover design.Plasma drug concentrations were determined by LC-MS/MS.The pharmacokinetic parameters were calculated by BAPP3.0.Results The major pharmacokinetic parameters of domperidone in... |
| Keywords: | Domperidone Pharmacokinetics Therapeutic equivalency Mass fragmentography |
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