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目的：进行国产与进口罗红霉素的生物利用度研究。方法：通过交叉试验对８名男性志愿者（２２．６ａ±ｓ２．１ａ）交叉口服罗红霉素３００ｍｇ国产胶囊剂和进口片剂，进行单剂量药物动力学研究。血药浓度采用微生物法进行测定。结果：口服国产胶囊和进口片剂的血药浓度＿时间曲线均符合二室模型，Ｃｍａｘ分别为９．５ｍｇ／Ｌ±１．３ｍｇ／Ｌ与９．０ｍｇ／Ｌ±１．０ｍｇ／Ｌ，Ｔｍａｘ为１．１４ｈ±０．１８ｈ与１．３１ｈ±０．２１ｈ，Ｔ１２β为１３．１ｈ±２．４ｈ与１３．６ｈ±２．２ｈ，ＡＵＣ为１０７ｍｇ·ｈ／Ｌ±２３ｍｇ·ｈ／Ｌ与１０８ｍｇ·ｈ／Ｌ±１４ｍｇ·ｈ／Ｌ。比较２种制剂的药物动力学参数，其差别均无显著意义（Ｐ＞０．０５）。与进口罗红霉素片相比较，国产罗红霉素胶囊剂的相对生物利用度为（９８±１３）％。口服该药４８ｈ尿药回收率为给药量的（１５±５）％。结论：国产罗红霉素胶囊体内过程与进口罗红霉素片剂相仿，２种制剂生物等效。
Objective: To study the bioavailability of domestic and imported roxithromycin. METHODS: A single dose pharmacokinetic study was conducted on a cross-sectional study of eight male volunteers (22.6a ± s2.1a) crossed with roxithromycin 300mg domestic capsules and imported tablets. Blood concentration was determined by the microbial method. Results: The plasma concentration-time curves of oral domestic capsules and imported tablets were in accordance with the two-compartment model with Cmax of 9.5mg / L ± 1.3mg / L and 9.0mg / L ± 1.0mg / L, respectively. Tmax Were 1.14h ± 0.18h and 1.31h ± 0.21h, T12β was 13.1h ± 2.4h and 13.6h ± 2.2h, AUC was 107mg · h / L ± 23mg · h / L and 108mg · H / L ± 14 mg · h / L. There was no significant difference in the pharmacokinetic parameters between the two preparations (P> 0.05). Compared with imported roxithromycin tablets, the relative bioavailability of domestic roxithromycin capsules was (98 ± 13)%. Oral 48h urinary drug recovery for the dose (15 ± 5)%. Conclusion: The process of domestic roxithromycin capsule is similar to the imported roxithromycin tablets, and the two preparations are bioequivalent.