Study on Pharmacokinetics and Bioequivalen of Multi-Absorption Enhancer and Puerarin Tablet (1.Key Laboratory of Modern Preparation of TCM , Ministry of Education, Nanchang, 330004, China;2.Department of Pharmacy,The People's Hospital of Ganzhou, Ganzhou, 341000)

LAI Jun; LIAO Zheng-gen; LIANG Xin-li; ZHAO Guo-wei; ZHANG Ping; ZHANG Xiao-hui

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Study on Pharmacokinetics and Bioequivalen of Multi-Absorption Enhancer and Puerarin Tablet (1.Key Laboratory of Modern Preparation of TCM , Ministry of Education, Nanchang, 330004, China;2.Department of Pharmacy,The People's Hospital of Ganzhou, Ganzhou, 341000)

更新时间：2024-01-04

- Study on Pharmacokinetics and Bioequivalen of Multi-Absorption Enhancer and Puerarin Tablet (1.Key Laboratory of Modern Preparation of TCM , Ministry of Education, Nanchang, 330004, China;2.Department of Pharmacy,The People's Hospital of Ganzhou, Ganzhou, 341000)
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 16, Issue 7, Pages: 142-146(2010)
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- Published：2010
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LAI Jun, LIAO Zheng-gen, LIANG Xin-li, et al. Study on Pharmacokinetics and Bioequivalen of Multi-Absorption Enhancer and Puerarin Tablet (1.Key Laboratory of Modern Preparation of TCM , Ministry of Education, Nanchang, 330004, China;2.Department of Pharmacy,The People's Hospital of Ganzhou, Ganzhou, 341000)[J]. Chinese journal of experimental traditional medical formulae, 2010, 16(7): 142-146.
DOI：

LAI Jun, LIAO Zheng-gen, LIANG Xin-li, et al. Study on Pharmacokinetics and Bioequivalen of Multi-Absorption Enhancer and Puerarin Tablet (1.Key Laboratory of Modern Preparation of TCM , Ministry of Education, Nanchang, 330004, China;2.Department of Pharmacy,The People's Hospital of Ganzhou, Ganzhou, 341000)[J]. Chinese journal of experimental traditional medical formulae, 2010, 16(7): 142-146. DOI：

摘要

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%。

Abstract

Objective: To establish an analytical method for the determination of puerarin in dog plasma with HPLC-FLD

and to evaluate the pharmacokinetics and relative-bioavailability of puerarin of tested multi-absorption enhancer and puerarin tablet after a single oral dose in healthy dogs. Method: Six healthy dogs took muti-absorption enhancer and puerarin tablets with a single oral dose in a randomized cross-over design in the case. The serum concentration of puerarin was determined by HPLC-FLD method. Result: The puerarin in test and reference formulations were Cmax (0.326±0.121) and (0.272±0.083) ng ·mL-1

tmax (2.750±0.957) and (4.500±1.732) h

t1/2α (1.157±0.748) and (1.223±0.311) h

t1/2β (6.679±2.552) and (1.987±0.386) h

AUC(0-t) (2.513±1.046) and (1.951±0.442) mg ·h ·L-1

AUC(0-∞) (5.035±2.190) and (3.001±1.382) mg ·h ·L-1

respectively. The relative bioavailability of puerarin was (128.8±31.2)%. Cmax

AUC(0-t) and AUC(0-∞) were not bioequivalent through the bioequivalent tests. Conclusion: The method is proved to be accurate

sensitive and rapid. Puerarin in the test formulation is not bioequivalent to the reference formulation. The relative-bioavailability of puerarin of tested multi-absorption enhancer and puerarin tablet is enhanced by 28.8 percents.

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