摘要
目的建立测定血浆中盐酸昂丹司琼浓度的高效液相色谱法,并以盐酸昂丹司琼片为参比制剂进行生物等效性研究。方法 20例健康男性志愿者单剂量随机交叉口服受试制剂和参比制剂各8 mg,应用RP-HPLC法测定血浆中昂丹司琼浓度,进行药物动力学及相对生物利用度研究。结果受试制剂与参比制剂的主要药动学参数:Cmax分别为(48.21±0.34)、(46.30±18.77)ng/mL;AUC0-t分别为(203.48±56.80)、(206.03±53.60)ng.h/mL;AUC0-∞分别为(223.24±55.74)、(227.14±55.59)ng.h/mL;t1/2分别为(4.39±1.75)、(4.22±1.27)h。受试制剂的相对生物利用度为101.1%±0.2%。结论两种制剂具有生物等效性。
Objective To establish an HPLC method for determining the content of ondansetron hydrochloride,and discuss the bioavailability of it with the reference preparation of ondansetron hydrochloride tablets.Methods 20 healthy volunteers were administered with 8 mg of test preparation or reference preparation randomly.The plasma concentration was determined by RP-HPLC method,to study the pharmacokinetics and relative bioavailability.Results The pharmacokinetic parameters of test and reference preparations were as follows：Cmax：（48.21±0.34）and（46.30±18.77）ng/mL;AUC0-t：（203.48±56.80）and（206.03±53.60）ng · h/mL;AUC0-∞：（223.24±55.74）and（227.14±55.59）ng · h/mL;t1/2：（4.39±1.75）and（4.22±1.27）h.The relative bioavailability of test preparation was 101.1%±0.2%.Conclusion The two preparations were bioequivalent.
出处
《实用药物与临床》
CAS
2011年第5期392-394,共3页
Practical Pharmacy and Clinical Remedies
关键词
盐酸昂丹司琼
口崩片
高效液相色谱
药物动力学
生物等效性
Ondansetron hydrochloride
Orally disintegrating tablet
HPLC
Pharmacokinetics
Bioequivalence
