摘要
目的评价甲硝唑片的生物等效性。方法将20名健康男性志愿者随机分为两组,分别交叉口服两种甲硝唑片,采用高效液相色谱法测定血药浓度;以3P97软件计算药代动力学参数,用方差分析和双单侧t检验及(1-2α)置信区间法分析两种甲硝唑片是否等效。结果单剂量口服600mg受试制剂和参比制剂,达峰时间(Tmax)为(1.425±0.373)h和(1.5±0.281)h,血药峰浓度(Cmax)为(8.999±0.800)μg/mL和(9.226±0.788)μg/mL;0～48h药时曲线下面积(AUC0→48)为(157.285±15.526)mg·h/L和(151.760±16.718)mg·h/L,受试制剂的相对生物利用度为(104.0±10.1)%。结论两种甲硝唑片具有生物等效性。
Objective To evaluate the bioequivalence （BE） of two kinds of metronidazole tablets. Methods Twenty healthy male volunteers were divided into two groups randomly and a single dosage of 600 mg of testing tablet or reference tablet were given to each volunteer in the crossover way. Plasma concentrations of metronidazole were measured by HPLC, and the 3P97 software was employed to calculate the parameter of metabolic dynamics of drugs. Statistical differences between the means were analyzed by using square analysis two one- side test and （1- 2α） believe- intervals. Results The pharmacokinetic parameters of metronidazole in the testing tablet and reference tablet were as follows： Tmax were （1.425±0.373）h and （1.5±0.281）h;Cmax were （8. 999 ±0. 800） μg/mL and （9. 226 ±0. 788） μg/mL; AUC0→4s were （157. 258 ±15. 526）mg· h/L and （151. 760 ±16. 718）mg ·h/L respectively. The relative bioavailability of testing tablet was （ 104. 0 ±10. 1 ）%. Conclusion The two metronidazole tablets were bioequivalent.
出处
《中国药业》
CAS
2006年第8期10-11,共2页
China Pharmaceuticals
