复方愈麻美芬缓释片在Beagle犬体内的药物动力学研究

目的对Beagle犬服用复方愈麻美芬缓释片和国外对照缓释片的药动学特性和生物利用度进行比较。方法HPLC法测定 6只Beagle犬服药后的血药浓度 ,计算出有关药物动力学参数 ,经统计学分析并将两者的计算参数进行比较。结果 6只Beagle犬服用复方愈麻美芬缓释片的血药浓度与服用国外对照缓释片基本一致。复方愈麻美芬缓释片中愈创木芬甘油醚的tpeak 为(3 0 0 0± 0 14 4 )h ,ρmax为 (13 79± 0 5 70 )mg·L-1,t1/ 2 为 (2 35 3± 0 2 5 5 )h ,AUC为 (139 1±9 0 83)mg·L-1·h ;氧去甲右美沙芬的tpeak为 (4 4 2 9± 0 0 88)h ,ρmax为 (0 30 1± 0 0 4 0 )mg·L-1,t1/ 2 为 (6 4 4 5± 0 5 5 1)h ,AUC为 (4 35 4± 0 4 79)mg·L-1·h ;盐酸伪麻黄碱的tpeak为 (2 6 10±0 14 6 )h ,ρmax 为 (1 174± 0 2 0 6 )mg·L-1,t1/ 2 为 (2 84 4± 0 82 5 )h ,AUC为 (8 2 6 6±2 0 30 )mg·L-1·h。与国外对照缓释片相比 ,复方愈麻美芬缓释片的生物利用度为 :愈创木芬甘油醚为 119 8% ;氧去甲右美沙芬为 10 2 4 % ;盐酸伪麻黄碱为 115 6 % ;两制剂tmax、ρmax和AUC间无显著的统计学差异。结论经双单侧t检验分析 ,服用复方愈麻美芬缓释片后其生物利用度与服用国外对照缓释片等效

Study on the pharmacokinetics of compound Yumameifen sustained-release tablets in Beagle dogs

Objective To compare with the pharmacokinetics and bioavaibility between compound Yumameifen sustained-release tablets and reference formulations in Beagle dogs.Methods A sensitive HPLC method was developed to determine the plasma drug concentration.The main pharmacokinetic parameters were calculated by the 3p97 pharmacokinetic calculation program.Using satistic analysis to compare compound sustained-tablets and reference formulations.Result Pharmacokinetic parameters of compound Yumameifen sustained-release tablets were obtained as follows:guaifenesin:t peak was (3.000±0.144) h,t 1/2 was 2.35 h,C max was ( 13.79±0.570)mg·L -1,AUC was (139.1±9.083)mg·h·L -1; dextromethorphan: t peak was(4.429±0.088) h,t 1/2 was (6.445±0.551) h, C max was (0.301±0.040) mg·L -1,AUC was (4.354±0.479)mg·h·L -1; pseudophedrine: t peak was (2.610±0.146) h,t 1/2 was (2.844±0.825)h,C max was (1.174±0.206)mg·L -1,AUC was (8.266±2.030)mg·h·L -1.The relative bioavailablity of guaifenesin,dextromethorphan and pseudophedrine respectively was 119.8%,102.4% and 115.6%.There wasn't significant difference between compound sustained-release tablets and reference formulations through a satistic analysis (t-test in t max,C max and AUC).Conclusion The result exhibited the test tablets were bioequivalent with the reference tablets.