卡托普利片在人体相对生物利用度测定
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文章编号：(2003)02-0057-06,卡托普利片在人体相对生物利用度测定
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张舒雅1 ，潘洪达2 ，赵春杰3
(1.朝阳市中心医院药材科，辽宁 朝阳122000； 2.盘锦市辽河油田卫生处，辽宁盘锦124010；
3. 沈阳药科大学药学院，辽宁沈阳110016)
摘要：目的 测定卡托普利片在人体内的相对生物利用度。方法18名健康志愿者单剂量口服卡托普利片，以反相高效液相色谱法测定其血药浓度。结果 受试制剂和参比制剂中卡托普利主要药物动力学参数为：达峰时间为(0.83±0.23)h和(0.81±0.28)h，达峰时药物质量浓度为 (22.88±13.64)mg·L-1和(20.96±8.06)mg·L-1，消除相半衰期为(1.95±0.11)h和 (1.89±0.11)h，药时曲线下面积为(66.92±11.15)mg·h·L-1和(67.85±12.33)mg·h·L-1。结论 试验制剂与参比制剂两种制剂生物等效。
关键词：药剂学；相对生物利用度；高效液相色谱法；卡托普利片；药物动力学
中图分类号：R914.1 文献标识码：A
Study on the relative bioavailability of captopril tablets in volunteers
ZHANG Shu-ya1 ，PAN Hong-da2 ，ZHAO Chun-Jie3
(1. The Center Hospital of Chaoyang, Chaoyang 122000, China; 2.The Health Administration of Liaohe ’s oil field, Panjin 124000, China; 3. School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016，China)
Abstract： Objective To study the relative bioavailability of captopril tablets in human being. Methods The randomized, crossed-over study was conducted in 18 healthy volunteers. After a single dose (containing 100 mg captopril), the plasma drug levels were determined by RP-HPLC. Results The main pharmacokinetic parameters of captopril in the test and reference formulation were as follows: tmax were ( 0.83±0.23) and (0.81±0.28) h；cmax were (22.88±13.64) and (20.96±8.06) mg·L-1, t1/2 were (1.95±0.11) and (1.89±0.11) h；AUC0→∝ were (66.92±11.15) and (67.85±12.33) mg·h·L-1, respectively. Conclusion It can be showed that the two formulations are bioequivalent.
Key words：pharmaceutics ; bioavailability；HPLC; captopril pharmacokinetics;
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