摘要
目的 :评价国产丙硫氧嘧啶肠溶胶囊的人体相对生物利用度。方法 :采用改进的高效液相色谱法测定20名男性健康受试者单剂量口服100mg丙硫氧嘧啶肠溶胶囊 (受试制剂 )和进口的丙硫氧嘧啶片 (参比制剂 )后的血药浓度 ,应用CRFB生物利用度统计程序对数据进行拟合。结果 :受试制剂和参比制剂的AUC0～t 分别为 (9 13±1 53)、(8 80±1 37) (μg·h)/ml,Cmax 分别为(3 02±0 71)、(3 03±0 66) μg/ml ,tmax 分别为 (4 51±0 24)、(1 13±0 44)h。两组参数均无统计学差异 (P>0 05) ,受试制剂的相对生物利用度为 (104 37±12 16) %。结论 :国产丙硫氧嘧啶肠溶胶囊与进口丙硫氧嘧啶片具有生物等效性。
OBJECTIVE:To evaluate the bioavailability of domestic propylthiouracil enteric coated capsule.METHODS:A modified RP-HPLC assay was used for determination of the plasma drug concentrations.In a randomized two-way crossover design,a single oral dose of100mg domestic propylthiouracil capsule(trial agent,A)and imported propyithiouracil tablet(reference agent,B)were given to20male healthy volunteers.The parameters were fitted by CRFB bioavailaility softˉware.RESULTS:The AUC 0～t ,C max and t max of A and B were(9.13±1.53)and(8.80±1.37)(μg·h)/ml,(3.02±0.71)and(3.03±0.66)μg/ml,(4.51±0.24)and(1.13±0.44)h respectively.There were no significant differences in parameters between2groups.The relative bioavailability of product A was(104.37±12.16)%.CONCLUSION:The results suggest that these two products were bioequivalent.
出处
《中国药房》
CAS
CSCD
北大核心
2005年第5期366-367,共2页
China Pharmacy
