复方枣仁片中左旋延胡索乙素的生物等效性  

The bioequivalence of L-tetrahydropalmatine in compound Zaoren tablets

作　　者：余继英[1] 陈璐[1] 邹静[1] 童荣生[1] 吴正中[1] 

机构地区：[1]四川省人民医院药剂科,四川成都610072

出　　处：《中国医院药学杂志》2011年第8期663-666,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的:以左旋延胡索乙素为指标,评价复方枣仁片的生物等效性。方法:21名男性健康受试者随机交叉单剂量口服试验制剂和参比制剂后,以HPLC法测定血清左旋延胡索乙素浓度,评价试验制剂中左旋延胡索乙素的相对生物利用度。结果:单剂量口服相等剂量(复方枣仁片2片/复方枣仁胶囊1粒)后,试验制剂和参比制剂的AUC0-12h分别为(627.0±228.8)和(614.0±205.4)μg.h.L-1;AUC0-∞分别为(698.8±236.4)和(681.7±224.5)μg.h.L-1;tmax分别为(1.4±0.3),(1.4±0.5)h;Cmax分别为(235.3±60.7),(227.5±65.5)μg.L-1。试验制剂的F0-12h为(108.0±43.3)%。对AUC0-24h、AUC0-∞、Cmax经对数转化后作方差分析、双单侧t检验,tmax作非参数法秩和检验,结果两组间差异无显著性。结论:以左旋延胡索乙素为指标,试验制剂复方枣仁片与参比制剂复方枣仁胶囊生物等效。OBJECTIVE To evaluate the bioequivalenee of L-tetrahydropalmatine in Compound Zaoren tablet. METHODS 21 healthy male volunteers were administered with an oral single dose of test and reference products respectively in a random crossover study. The concentrations of L-tetrahydropalmatine in serum were determined by RP-HPLC using diazepam as internal standard. RESULTS The AUG, 12h for L-tetrahydropalmatine of test and reference were （627. 0 ± 228. 8） and （614. 0 ± 205.4）μg·h·L^-1;AUC0-∞ were （698. 8 ±236. 4） and（681.7 ± 224. 5）μg·h·L^-1 ;Tm,x were （1.4 ±0. 3） and （1.4 ± 0. 5）h; Cmax were （235.3 ± 60. 7） and （227. 5 ±65.50）μg·L^-1 ,respectively after an oral single dose （2 tablets of Compound Zaoren tablet or 1 capsule of Compound Zaoren capsule）. There was no significant difference between the main pharmaeokinetic parameters and the relative bioavailability of the test was （ 108.0 ± 43. 3） %. CONCLUSION It is bioequivalent for L-tetrahydropalmatine in the two Compound Zaoren products after a single oral dose.

关 键 词：左旋延胡索乙素 高效液相色谱法 生物等效性 

分 类 号：R969.1[医药卫生—药理学]