【摘要】 目的对盐酸青藤碱缓释胶囊进行相对生物利用度和体内外相关性研究。方法以随机分组自身对照、间隔1周交叉实验设计法,用高效液相色谱法测定盐酸青藤碱的浓度,对6条健康家犬比较单剂量灌服盐酸青藤碱缓释胶囊和正清风痛宁缓释片各120 mg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血药浓度-时间曲线相似,其t1/2分别为20.72和8.57 h,tmax分别为9.83和2.67 h,Cmax分别为893.12和1 334.45 ng.mL-1,浓度-时间曲线下面积(AUC0-t)分别为13 503.40和13 057.73 ng.h.mL-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tmax明显延后,t1/2明显延长。更多还原

【Abstract】 Objective To study the pharmacokinetics and relative bioavailability of sinomenine hydrochloride sustained-released capsules in dogs. Methods Single oral dose of 120 mg sinomenine hydrochloride sustained-released capsules and zhengqing fengtongning sustained-released tables were given to 6 dogs in an open randomized crossover way to study the pharmacokinetics parameter and relative bioavailability.Sinomenine hydrochloride concentration in blood was determined by an HPLC method. Results The time-concentration curve of sinomenine hydrochloride sustained-released capsules was similar to that of zhengqing fengtongning sustained-released tables,and their AUC0-t was 13 503.40 and 13 057.73 ng·h·mL-1;Cmax was 893.12 and 1 334.45 ng·mL-1;t1/2 was 20.72 and 8.57 h;tmax was 9.83 and 2.67 h,respectively.The result showed that there was no significant difference between sinomenine hydrochlorid sustained-released capsules and zhengqing fengtongning sustained-released tablets. Conclusion The two formulations of sinomenine hydrochloride sustained-released capsules and zhengqing fengtongning sustained-released tables were bioequivalent,although the fore has a longer t1/2 and more postponed tmax.更多还原