论文部分内容阅读
１０名健康男性志愿者交叉口服３００ｍｇ国产罗红霉素颗粒剂和进口片剂，进行国产制剂生物利用度研究，采用微生物法测定不同时间的血药浓度。结果罗红霉素颗粒剂和进口片剂两种制剂的血药浓度曲线均符合二室模型。Ｃｍａｘ分别为８．２８±０．５６ｍｇ／Ｌ和８．４２±０．７８ｍｇ／Ｌ，达峰时间分别为１．５１±０．２２ｈ和１．４２±０．１８ｈ，Ｔ１／２β分别为１２．２０±０．８５ｈ和１２．５８±０．９３ｈ，ＡＵＣ分别为１２０．５８±１２．９５ｍｇ／Ｌ·ｈ－１，和１１７．８０±１３．６８ｍｇ／Ｌ·ｈ－１两种制剂的药代动力学参数统计学检查无显著性差异。国产罗红霉素颗粒剂相对于进口片剂的生物利用度为１０２．７９±８．６８％，两种制剂生物等效。
10 healthy male volunteers oral administration of 300mg domestic roxithromycin granules and imported tablets, domestic bioavailability of preparations, the determination of blood concentration at different times using the microbiological method. Results Roxithromycin granules and imported tablets of two formulations of blood concentration curves are in line with the two-compartment model. C max were 8.28 ± 0.56 mg / L and 8.42 ± 0.78 mg / L, respectively. The time to peak reached 1.51 ± 0.22 h and 1.42 ± 0.18 h, respectively, and T1 / 2β were 12 .20 ± 0.85h and 12.58 ± 0.93h, AUC of 120.58 ± 12.95mg / L · h-1 and 117.80 ± 13.68mg / L · h-1 Pharmacokinetic parameters of statistical tests showed no significant difference. The bioavailability of domestic roxithromycin granules relative to imported tablets was 102.79 ± 8.68%, and both formulations were bioequivalent.