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８名男性健康志愿者交叉口服３００ｍｇ国产罗红霉素胶囊和进口片剂，进行国产制剂生物利用度研究，血药浓度用微生物法测定。结果表明：口服国产和进口两种制剂的血药浓度时间曲线均符合二室模型，Ｃｍａｘ分别为８．５９±１．０４和８．０５±１．３９ｍｇ／Ｌ，于１．３９±０．２５和１．５４±０．３５ｈ达峰，Ｔ１／２分别为１３．４５±３．３２和１４．０９±４．８７ｈ，ＡＵＣ是１１７．５±３２．０和１１５．２±２１．８ｍｇ·ｈ－１·Ｌ－１，比较两种制剂的药代动力学参数均无显著性差异，Ｐ＞０．０５。国产罗红霉素胶囊的相对生物利用度为１０２．０％，两种制剂生物等效。本项研究为国产罗红霉素胶囊的临床应用提供了指标和依据。
Eight healthy volunteers cross-oral administration of 300mg domestic roxithromycin capsules and imported tablets, domestic bioavailability of formulations, plasma concentrations measured by the microbial method. The results showed that the plasma concentration time curves of domestic and imported oral preparations both fit the two-compartment model with Cmax of 8.59 ± 1.04 and 8.05 ± 1.39 mg / L, respectively, at 1.39 ± 0. 25 and 1.54 ± 0.35h, respectively, T1 / 2 was 13.45 ± 3.32 and 14.09 ± 4.87h, AUC was 117.5 ± 32.0 and 115.2 ± 21.8 mg · H-1 · L-1. There was no significant difference in the pharmacokinetic parameters between the two preparations (P> 0.05). The relative bioavailability of domestic roxithromycin capsules was 102.0%, and both formulations were bioequivalent. This study provides an index and basis for the clinical application of domestic roxithromycin capsules.