盐酸青藤碱缓释胶囊的家犬体内药动学和相对生物利用度研究

 目的研究口服盐酸青藤碱缓释胶囊在家犬体内药动学和相对生物利用度。方法以随机分组自身对照、间隔1周交叉试验设计法,用高效液相色谱法测定盐酸青藤碱的浓度,在6条健康家犬身上比较单剂量po 120 mg盐酸青藤碱缓释胶囊和正清风痛宁缓释片后的药动学参数和相对生物利用度。结果盐酸青藤碱缓释胶囊和正清风痛宁缓释片的药-时曲线相似,其t_1/2分别为(25.19±10.94)和(20.48±6.55)h,t_max分别为(8.67±1.63)和(5.7±1.51)h,ρ_max分别为(1 012.23±510.82)和(1 031.66±546.15)μg·L^-1,AUC_0-30分别为(13 797.04±4 915.68)和(15 507.17±6 263.07)μg·h·L^-1。结论盐酸青藤碱缓释胶囊和正清风痛宁缓释片具有等效性,盐酸青藤碱缓释胶囊t_max明显延后,t_1/2明显延长。

Studies on Pharmacokinetics and Relative Bioavailability of Sinomenine Hydrochioride Sustained-Released Capsules in Dogs

OBJECTIVE To study the pharmacokinetics and bioavailability of sinomenine hydrochloride sustained-release capsules in dogs.METHODS 120 mg single oral dose of sinomenine hydrochloride sustained-release capsules and sinomenine hydrochloride sustained-release tablets were given to 6 dogs in an open randomized crossover way.sinomenine hydrochloride concentration in blood was assayed by HPLC method.RESULTS The relative bioavailability of sinomenine hydrochloride sustained-release capsules was(88.97%).The time-concentration curve of sinomenine hydrochloride sustained-release capsules was similar to that of sinomenine hydrochloride sustained-released tablets,and their AUC_0-30 were(13 797.04±4 915.68) and(15 507.17±6 263.07)μg·h·L^-1;ρ_max were(1 012.23±510.82) and(1 031.66±546.15)μg·L^-1;t_1/2 were(25.19±10.94) and(20.48±6.55)h;t_max were(8.67±1.63) and(5.7±1.51)h,respectively.The statistical analysis on above parameters showed that there was no significant difference between sinomenine hydrochloride sustained-release capsules and sinomenine hydrochlorid sustained-release tablets.CONCLUSION Two formulations are bioequivalent.