Stoll R G, Chao G C, Hoyt H J, Yacobi A
J Pharm Sci. 1978 Sep;67(9):1328-9. doi: 10.1002/jps.2600670940.
Two methaqualone tablets that exhibited different in vitro dissolution rates were administered to 11 normal healthy male volunteers. Serial blood samples were withdrawn following administration of each tablet, and plasma methaqualone concentrations were determined by an established spectrophotofluormetric assay. Both tablets produced virtually identical plasma concentration versus time profiles in humans, and no statistically significant differences in either the rate or extent of drug absorbed were detected. The results indicate that there is no correlation between in vivo bioavailability and the modified NF in vitro dissolution test used.
将两种体外溶出速率不同的甲喹酮片给予11名正常健康男性志愿者。服用每片药后采集系列血样，用既定的分光荧光测定法测定血浆中甲喹酮浓度。两种片剂在人体内产生的血浆浓度-时间曲线几乎相同，在药物吸收速率或程度方面均未检测到统计学上的显著差异。结果表明，体内生物利用度与所采用的改良《国家处方集》体外溶出试验之间不存在相关性。
