盐酸利托君片在中国健康志愿者体内的生物等效性  

Bioequivalence of ritodrine hydrochloride tablets in Chinese healthy volunteers

作　　者：陶春蕾[1] 许钒[1] 宋欣 周燕 

机构地区：[1]安徽中医学院,合肥230031 [2]安徽万邦医药科技有限公司,合肥230088

出　　处：《中国新药杂志》2011年第8期712-715,共4页Chinese Journal of New Drugs

摘　　要：目的：研究不同生产厂家生产的利托君片的生物等效性。方法：根据身高体重相近原则,18例健康女性受试者采用双周期两交叉给药方案,分别一次性口服2片（10 mg.片-1）试验盐酸利托君片或参比盐酸利托君片,用LC-MS/MS内标法测定健康受试者血浆中盐酸利托君浓度,采用DAS 2.0.1软件计算药动学参数,并进行2种制剂的生物等效性评价。结果：经药动学参数计算其参比药t1/2=（2.623±1.223）h,Cmax=（12.425±6.891）ng·mL-1,Tmax=（0.769±0.555）h,AUC0~t=（28.416±9.102）ng·h·mL-1,AUC0~∞=（33.199±12.338）ng·h·mL-1;试验制剂t1/2=（2.539±0.670）h,Cmax=（14.475±11.262）ng·mL-1,Tmax=（0.741±0.509）h,AUC0~t=（30.499±11.402）ng·h·mL-1、AUC0~∞=（34.258±12.094）ng·h·mL-1。试验制剂的相对生物利用度AUC0~t=（109.6±23.0）%,AUC0~∞=（108.0±26.2）%。结论：受试制剂与参比制剂生物等效。Objective：To investigate the bioequivalence of different ritodrine tablets produced by different manufacturers.Methods： According to the similarity of height and weight,a biperiodic two cross test was designed.Totally 18 healthy female subjects were orally administered with 2 pieces（10 mg per piece） of test or reference ritodrine hydrochloride tablets.Then,ritodrine HCl concentrations in plasma were determined by LC-MS/MS method with an internal standard.The pharmacokinetic parameters were calculated using the DAS 2.0.1 software,and the bioequivalence of the two preparations was evaluated.Results： The pharmacokinetic parameters of reference tablets were t1/2=（2.623±1.223） h,Cmax=（12.425±6.891） ng·mL-1,Tmax=（0.769±0.555） h,AUC0~t=（28.416±9.102） ng·h·mL-1,AUC0~∞=（33.199±12.338） ng·h·mL-1;those of test tablets were t1/2=（2.539±0.670） h,Cmax=（14.475±11.262） ng·mL-1,Tmax=（0.741±0.509） h,AUC0~t=（30.499±11.402） ng·h·mL-1,AUC0~∞=（34.258±12.094） ng·h·mL-1.The relative bioavailability of the test tablets was（109.6±23.0）%（AUC0~t） or（108.0±26.2）%（AUC0~∞）.Conclusion： The test and reference ritodrine hydrochloride tablets are bioequivalent.

关 键 词：利托君 LC-MS/MS 生物等效性 

分 类 号：R969.1[医药卫生—药理学]