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目的:建立家犬血浆中葛根素的高效液相色谱-荧光法测定方法;研究单剂量口服复合吸收促进剂-葛根素片在家犬体内的药物动力学和相对生物利用度。方法:6只健康家犬采用随机交叉自身对照试验,分别单次口服复合吸收促进剂-葛根素片和普通葛根素片,采用高效液相色谱-荧光法测定。结果:复合吸收促进剂-葛根素片和普通葛根素片的Cmax分别为(0.326±0.121)ng·mL-1和(0.272±0.083)ng·mL-1,tmax分别为(2.750±0.957)h和(4.500±1.732)h,t1/2α分别为(1.157±0.748)h和(1.223±0.311)h,t1/2β分别为(6.679±2.552)h和(1.987±0.386)h,AUC(0-t)分别为(2.513±1.046)mg·h·L-1和(1.951±0.442)mg·h·L-1,AUC(0-∞)分别为(5.035±2.190)mg·h·L-1和(3.001±1.382)mg·h·L-1。复合吸收促进剂-葛根素片与普通葛根素片相比较相对生物利用度为(128.8±31.2)%。Cmax、AUC(0-t)及AUC(0-∞)经生物等效性检验均为不等效。结论:试验建立的分析方法准确、灵敏、快速。复合吸收促进剂-葛根素片与普通葛根素片相比生物不等效,复合吸收促进剂-葛根素片的生物利用度提高了28.8%。
OBJECTIVE: To establish a method for the determination of puerarin in dog plasma by high performance liquid chromatography-fluorescence method and to study the pharmacokinetics and relative bioavailability of puerarin in a single dose oral compound absorption accelerator. Methods: Six healthy domestic dogs were randomized cross-self-controlled trials, respectively, a single oral administration of complex absorption enhancers - Puerarin tablets and ordinary puerarin tablets, using high performance liquid chromatography - fluorescence determination. Results: The Cmax of puerarin and puerarin were (0.326 ± 0.121) ng · mL-1 and (0.272 ± 0.083) ng · mL-1, respectively, and the tmax were (2.750 ± 0.957) h And (4.500 ± 1.732) h, t1 / 2α were (1.157 ± 0.748) h and (1.223 ± 0.311) h respectively, and t1 / 2β were (6.679 ± 2.552) h and (1.987 ± 0.386) t were 2.513 ± 1.046 mg · h · L-1 and 1.951 ± 0.442 mg · h · L-1, respectively, and the AUC values were (5.035 ± 2.190) mg · h · L-1 And (3.001 ± 1.382) mg · h · L-1, respectively. The relative bioavailability of composite absorption enhancer-puerarin tablets was (128.8 ± 31.2)% compared with that of puerarin tablets. Cmax, AUC (0-t) and AUC (0-∞) were not equivalent by the test of bioequivalence. Conclusion: The experimental method established is accurate, sensitive and rapid. Bioabsorbable agent - puerarin tablets compared with ordinary puerarin tablets bio-equivalent, bioavailability of the composite absorption enhancer - puerarin tablets increased by 28.8%.