摘要
目的评价国内不同厂家罗红霉素片的相对生物利用度和生物等效性。方法18名男性健康受试者采用随机、自身对照、交叉法单剂量口服两个不同厂家的罗红霉素片后,采用微生物法测定血浆中罗红霉素质量浓度。结果单剂量口服300mg罗红霉素片受试和参比制剂后的达峰时间tmax分别为(1.68±0.76)和(1.86±0.83)h;峰值血药质量浓度Cmax分别为(6.87±0.87)和(7.12±1.23)mg·L-1;t1/2β分别为(14.96±2.48)和(16.23±1.97)h;药时曲线下面积AUC(0→48)分别为(72.84±12.62)和(70.81±13.92)mg·h·L-1。两种片剂所有的药物动力学参数均无显著性差异(P>0.05),受试制剂的相对生物利用度F为(102.9±17.8)%。结论两种制剂生物等效。
Objective To evaluate the relative bioavailability and bioequivalence of test roxithromycin tablets compared with reference roxithromycin tablets. Methods 18 male healthy volunteers orally took a single dose of 300mg tablets in randamized self-crossover ways. The plasma concentrations of roxithromycin were determined by microbiological method. Results The pharmacokinetic parameters of reference and test drugs were as follows: tmax (1.68±0. 76) and (1.86±0. 83) h; Cmax(6.87±0. 87) and (7. 12±1.23)mg·L^-1; AUC(0→48) (72.84±12.62) and (70. 81± 13.92) mg·h ·L^-1, respectively. No statistical difference was found between roxithromycin tablets in pharmacokinetic parameters(P〉0. 05). The relative bioavailability of roxithromycin tablcts was [102. 9±17. 8)%, Conclusion Two preparations of roxithromycin tablets are bioequivalent.
出处
《西北药学杂志》
CAS
2007年第6期291-293,共3页
Northwest Pharmaceutical Journal
关键词
罗红霉素片
生物利用度
生物等效性
微生物法
roxithromycin tablets
bioavailability
bioequivalence
microbiological method