摘要
目的：用国产罗红霉素胶囊（ＲＭ－Ｂ）和颗粒剂（ＲＭ－Ｃ）与法国产罗力得片（ＲＭ－Ａ）进行人体药物动力学和生物等效性比较。方法：选择１０名健康成年男子，用自身交叉对照试验方法，分别单剂量一次口服罗红霉素ＲＭ－Ａ、ＲＭ－Ｂ、ＲＭ－Ｃ三种制剂３００ｍｇ。罗红霉素的血药浓度用微生物法测定。罗红霉素血药浓度－时间数据用３Ｐ８７程序自动拟合求算药动学参数。结果：ＲＭ的Ｔ１／２β均为１３ｈ左右，Ｔｍａｘ≈２ｈ，Ｃｍａｘ≈８．３６μｍｏｌ·Ｌ－１。ＲＭ－Ｂ和ＲＭ－Ｃ与ＲＭ－Ａ比较相对生物利用度为９５．４％和９８．９％。结论：双单侧ｔ检验结果，ＲＭ－Ｂ和ＲＭ－Ｃ与ＲＭ－Ａ为生物等效制剂。
Objective\ The pharmacokinetics and bioavailability of capsule (RM B) and granule (RM C) of domestic product roxithromycin (RM) were compared with those of France product RM tablet (RM A). Method\ A single oral dose of 300 mg roxithronycin was given according to a cross over design in 10 healthy volunteers. Plasma levels of RM was measured by bioassay method. The concentration time curver of RM was fitted to two compartment model measured by 3P87 program. Results\ The pharmacokinetic paraments of RM were T 1/2β ≈13 h, T max ≈2 h, C max ≈8 36 μmol·L -1 ,respectively. The relative bioavailability of RM B and RM C were 95 4% and 98 99%, respectively. Conclusion\ The result by two￣one sided test showed that the three formulations of RM B, RM C and RM A were bioequivalent.
出处
《中国药理学通报》
CAS
CSCD
北大核心
1997年第2期173-175,共3页
Chinese Pharmacological Bulletin
