利巴韦林片人体生物等效性研究  

Studies on the bioequivalence of ribavirin tablet in healthy volunteers

作　　者：靖百谦[1] 周文[1] 王凤山[2] 

机构地区：[1]山东大学齐鲁医院,济南250012 [2]山东大学药学院,济南250012

出　　处：《齐鲁药事》2006年第6期367-369,共3页qilu pharmaceutical affairs

摘　　要：目的 评价2种国产利巴韦抹片剂的生物等效性。方法 采用自身交叉试验方法．22名健康志愿者顿服1000mg利巴韦林片后，在规定时间内采血。以HPLC法测定血清药物浓度;以DAS（Ver1．0）新药统计软件计算主要药动学参数，并评价2种国产利巴韦林片之间的生物等效性。结果 受试制剂和参比制剂主要药动学参数t1/2分别为22．36±3．28h和21．57±2．42h。Tmax分别为2．00±0．00h和1．98±0．11h．Cmax分别为0．80±0．12pg·ml^-1和0．85±0．22pg·ml^-1 AUC0-72”分别为15．77±3．90μg·h·ml^-1和15．12±2．98／Lg·h·ml^-1，AUC0-∞。分别为17．75±4．47μg·h·ml^-1和16．75±3．42μg·h·ml^-1，试验制剂相对于参比制剂的相对生物利用度为104．71％±16．49％。结论 方差分析和双向单侧t检验结果表明两种利巴韦林片剂为生物等效制剂。OBJECTIVE To evaluate the bioequivalence between two kinds of ribavirin tablets. METHODS A single oral dose of 1000 mg ribavirin tablet was given respectively to 22 healthy volunteers in an open randomized cross-over test for comparison of relative bioavailability in human. Ribavirin serum concentration was determined by HPLC. RESULTS The main pharmaeokinetie parameters were as follows： t1/2 of test preparation and reference preparation were 22. 36±3. 28h and 21. 57±4- 2. 42h,Tmax were 2.00±0. 00h and 1.98±0. 11h,Cmax were 0. 80±0.12μg·ml^-1 and 0.85±0. 22μg· ml^-1 ,AUC0-72 were 15. 77±3. 90μg·h ·ml^-1and 15.12±2. 98μg· h ·ml^-1 ,AUC0-∞ were 17. 75±4. 47μg·h·ml^-1 and 16. 75±3. 42μg·h·ml^-1 ,respectivdy. There were no statistical differences of all parameters between two preparations（ P 〉0. 05）. The mean rela tive bioavailability of test preparation versus reference preparation was 104. 71~ q-16. 49 ~ . The test preparation was bioequivalent to reference preparation. CONCLUSION The result of variance analysis and two one-side test showed that the two formulations were bioequivalent.

关 键 词：利巴韦林片 生物等效性 高效液相色谱法 

分 类 号：R969.1[医药卫生—药理学]