论文部分内容阅读
目的:研究正清风痛宁肠溶片在Beagle犬体内的生物等效性。方法:12只Beagle犬随机交叉单剂量灌胃100mg湖南正清风痛宁肠溶片(受试制剂)或西安正清风痛宁肠溶片(参比制剂),采用高效液相色谱法测定青藤碱的血药浓度,用3p97软件拟合药动学参数,并计算生物利用度。结果:2种药物在犬体内药-时曲线符合一室模型,t1/(2Ke)分别为(84.77±19.33)和(87.63±18.26)min,Cmax分别为(0.18±0.049)和(0.13±0.018)μg·mL-1,tmax分别为(79.27±15.62)和(69.66±16.41)min,AUC0～t分别为(38.51±13.23)和(35.43±9.84)μg·h-1·mL-1;相对生物利用度为(108.71±8.97)%。结论:经方差分析和双单侧t检验,2种正清风痛宁肠溶片具有生物等效性(P>0.05)。
Objective: To study the bioequivalence of Zhengqing Fengtongning enteric-coated tablet in Beagle dogs. Methods: Twelve Beagle dogs were randomized to receive a single dose of 100mg Hunan Zhengqing Fengtongning enteric-coated tablet (test preparation) or Xi’an Zhengqing Fengtongning enteric-coated tablet (reference preparation), and the contents of Ivy Pharmacokinetic parameters were calculated using 3p97 software and bioavailability was calculated. Results: The drug-time curves of two drugs in a canine model were consistent with those of the one-compartment model. The t1 / (2Ke) were (84.77 ± 19.33) and (87.63 ± 18.26) min and the Cmax were (0.18 ± 0.049) and (0.13 ± 0.018 ) (μg · mL-1) and tmax were (79.27 ± 15.62) and (69.66 ± 16.41) min, respectively, and AUC0 ~ t were (38.51 ± 13.23) and (35.43 ± 9.84) μg · h-1 · mL- Bioavailability was (108.71 ± 8.97)%. CONCLUSION: Two kinds of Zhengqing Fengtongning enteric-coated tablets are bioequivalent (P> 0.05) by means of analysis of variance and double unilateral t test.