复方磺胺甲上左（口）右（恶）唑片在正常从体内的药动学及相对生物利用度

 目的：研究了10名志愿受试者自身交叉 po 单剂量Co-SMZ片和Co-SMZ分散片800 mg的药动学及相对生物利用度。方法：按照随机交叉试验设计，采集服药后0.25，0.5，0.75，1，2，3，4，6，8，10，12，24，36，48 h的血样本，用I-IPLC测定SMZ和TMP的血药浓度。结果：Co-SMZ分散片及Co-SMZ片中SMZ和TMP的主要药动学参数分别为：c_max为(46.69士7.66)，(44.61士6.37)μg·ml^-1和(1.82士0.49)，(1.63士0.43)μg·ml^-1；t_max为(3.41士1.59)，(3.4士0.84)h和(1.48士0.83)，(1.50±0.81)h；AUC=(761士129.37)，(761.79士145.6)μg·h·ml^-1和(26.91土3.89)，(26.96士4.71)μg·h·ml^-1。两种制剂的药动学参数除TMP的Ka值P<0.05外，其他参数均无显著性差异(P>0.05)。结论：受试制剂相对于参比制剂的相对生物利用度分别为(101.28±14.35)%，(101.26±15.76)%。受试制剂与参比制剂生物等效。

Pharmacokinetics and relative bioavailability of co-trimexazole in healthy volunteers

OBJECTIVE: The pharmacokinetics and relative bioavailability of dispersible tablet of co trimexazole were studied in 10 healthy male volunteers. METHODS: A single oral dose of 800 mg co trimexazole of the two formations(test and reference preparations) was given in a randomized 2 way cross over design.Blood samples were withdrawn up to 48 hours post administration.Plasma concentrations of SMZ and TMP were assayed by HPLC. RESULTS: The main pharmacokinetic parameters of SMZ and TMP in the test preparation and the reference preparation were as following.c_max:(46.69±7.66)，(44.61±6.37) μg·ml^-1and (1.82±0.49)，(1.63±0.43) μg·ml^-1；t_max:(3.41±1.59),(3.4±0.84) h and (1.48±0.83),(1.50±0.81) h;AUC(761±129.37),(761.79±145.6) μg·h·ml^-1and (26.91±3.89),(26.96±4.71) μg·h·ml^-1,respectively. CONCLUSION: The relative bioavailability of the test preparation was (101.28±14.35)%(SMZ) and (101.26±15.76)% (TMP) to the reference preparation,indicating that both preparations were bioequivalent.