| 吲达帕胺缓释片人体药动学和生物等效性研究 |
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| 引用本文： | 尹银华,金晶,毛志海,刘明胜,王小路,李拓,甘方良. 吲达帕胺缓释片人体药动学和生物等效性研究[J]. 中国医院药学杂志, 2020, 40(24): 2540-2543,2588. DOI: 10.13286/j.1001-5213.2020.24.08 |
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| 作者姓名： | 尹银华 金晶 毛志海 刘明胜 王小路 李拓 甘方良 |
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| 作者单位： | 1. 遵义医科大学第五附属医院, 广东 珠海 519100;2. 湖北省药品监督管理局技术审评核查中心, 湖北 武汉 430071;3. 真奥金银花药业有限公司, 湖北 咸宁 437100;4. 咸宁市中心医院临床药理研究中心, 湖北 咸宁 437100 |
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| 基金项目： | 咸宁市科技局资助项目（编号：咸科技发〔2019〕8号） |
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| 摘 要： | 目的：研究吲达帕胺试验制剂（缓释片）和参比制剂（片剂）的人体药动学和生物等效性。方法：24名健康志愿者按随机双周期交叉试验设计，分别口服受试制剂（吲达帕胺缓释片）和参比制剂（吲达帕胺缓释片）1.5 mg，采用液相色谱-串联质谱（LC-MS/MS）分析方法测定吲达帕胺的全血浓度。利用DAS药动学程序计算其药动学参数和评价其生物等效性。结果：吲达帕胺试验制剂和参比片剂的主要药动学参数：Cmax分别为（32.9±7.1），（32.3±5.4）ng·mL-1；Tmax分别为11（5，15），12（5，15）h；T1/2ke分别为（15.0±2.2），（14.9±2.1）h；AUC0-t分别为（977.3±217.7），（965.1±179.6）ng·h·mL-1；AUC0-∞分别为（1 028.6±237.1），（1 015.3±193.7）ng·h·mL-1；受试制剂相对生物利用度为（101.27±11.3）%。结论：经方差分析及双单侧t检验结果显示，受试的吲达帕胺缓释片与参比的吲达帕胺缓释片具有生物等效性。
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| 关 键 词： | 吲达帕胺 液相色谱-串联质谱法 药动学 生物等效性 |
| 收稿时间： | 2020-05-10 |
Pharmacokinetics and bioequivalence study of indapamide sustained-release tablets in human whole blood |
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| YIN Yin-hua,JIA Jing,MAO Zhi-hai,LIU Ming-sheng,WANG Xiao-lu,LI To,GAN Fang-liang. Pharmacokinetics and bioequivalence study of indapamide sustained-release tablets in human whole blood[J]. Chinese Journal of Hospital Pharmacy, 2020, 40(24): 2540-2543,2588. DOI: 10.13286/j.1001-5213.2020.24.08 |
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| Authors: | YIN Yin-hua JIA Jing MAO Zhi-hai LIU Ming-sheng WANG Xiao-lu LI To GAN Fang-liang |
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| Affiliation: | 1. Department of pharmacy, the Fifth Affiliated(Zhuhai) Hospital of Zunyi Medical University, Guangdong Zhuhai 51900, China;2. Hubei Drug Administration Center for Evalution and Inspection, Hubei Wuhnn 430071, China;3. Zhenao Jinyinhua Pharmaceutical Limited Company, Hubei Xianning 437100, China;4. the Clinical Pharmacology Center of Xianning Central Hospital, Hubei Xianning 437100, China |
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| Abstract: | OBJECTIVE To study the pharmacokinetics and bioequivalence of indapamide test tablets and reference tablets in healthy volunteers.METHODS A single oral dose of 1.5 mg the test or the reference preparation was given to 24 healthy volunteers in a randomized two-period crossoner study.LC-MS/MS method for the determination of indapamide in human whole blood.A LC/MS/MS method for the determination of indapamide in human whole blood were established and validated.RESULTS The main pharmacokinetics parameters of test sustained-release tablets and reference tablets were as follows:Cmax were(32.9±7.1)and(32.3±5.4)ng·mL-1;Tmax were 11(5,15)and 12(5,15)h;T1/2ke were(15.0±2.2)and(14.9±2.1)h;AUC0-t were(977.3±217.7)and(965.1±179.6)ng·h·mL-1;AUC0-∞were(1 028.6±237.1)and(1 015.3±193.7)ng·h·mL-1;The relative bioavalability of the test tabtels of indapaminde was(101.27±11.3)%.CONCLUSION The results of analysis of variance and two and one-sided t-tests show that the tested pindapamide sustained-release tablets are bioequivalent to the pindapamide sustained-release tablets. |
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| Keywords: | indapamide LC/MS/MS pharmacokinetics bioequivalence |
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