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

赵真龄;谭家风;卓海通;徐进

中国药学杂志 ›› 2000, Vol. 35 ›› Issue (04) : 257-259.

中国药学杂志
中国药学杂志 ›› 2000, Vol. 35 ›› Issue (04) : 257-259.
临床药学

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

  • 赵真龄；谭家风；卓海通；徐进
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Pharmacokinetics and relative bioavailability of co-trimexazole in healthy volunteers

  • Zhao Zhenling
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摘要

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：cmax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；tmax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。

Abstract

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two formations(test and reference preparations) was given in a randomized 2way crossover design.Blood samples were withdrawn up to 48 hours post administration.Plasma concentrations of SMZ and TMP were assayed by HPLC.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.cmax:(46.69±7.66)，(44.61±6.37) μg·ml-1and (1.82±0.49)，(1.63±0.43) μg·ml-1；tmax:(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.

关键词

SMZ / TMP / HPLC / 药动学 / 相对生物利用度

Key words

SMZ / TMP / HPLC / pharmacokinetics / relative bioavailability

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赵真龄;谭家风;卓海通;徐进. 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[J]. 中国药学杂志, 2000, 35(04): 257-259
Zho Zhenling . Pharmacokinetics and relative bioavailability of co-trimexazole in healthy volunteers[J]. Chinese Pharmaceutical Journal, 2000, 35(04): 257-259

参考文献

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