阿奇霉素分散片人体相对生物利用度实验研究

Bioavailability of azithromycin dispersive tablet in normal volunteers

１２名健康志愿者随机自身交叉单剂量口服阿奇霉素分散片和阿奇霉素片进行生物利用度研究，用微生物杯碟法测定血清中阿奇霉素浓度。结果表明阿奇霉素两种制剂的体内药时数据符合二室模型，Ｃｍａｘ分别为０．３４和０．３６μｇ／ｍｌ；ｔｐ为１．９７和１．９０ｈ；ｔ为４４．８１和４２．９６ｈ；ＡＵＣ（０～１６８）为７．４９和７．４７ｍｇ·ｈ·Ｌ－１。阿奇霉素分散片相对生物利用度为１０１．７４±１４．５６％，表明阿奇霉素分散片与阿奇霉素片具有生物等效性。

The bioavailability of azithromyein dispersive tablet was studied in 12 normal male volunteers. A single oraldose of 500mg azithromycin dispersive tablet or common tablet was given according to a crossover design. Serumconcentrations of azithromycin were measured by bioassay. The concentration-time curves of dispersive tabletand general tablet fitted to a twocompartment open model.Peak serum levels of dispersive tablet and generaltablet reached 0.34 and 0.36hμg/ml, at 1.97 and 1.90h respectively. The t1/2 βwere 44.81 and 42.96h. The AUC were7.49 and 7.47mg · h · L-1 respectively. The relative bioavaliability of dispersive tablet to general tablet was 101.74±14.56 % , so it demonstrated that both fornation had bioequivalence.