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高效液相色谱法测定犬血浆中葛根素含量及缓释片相对生物利用度研究

Quantitative determination of puerarin in dog plasma by HPLC and study on the relative bioavailability of sustained release tablets.

作者信息

Ren Fuzheng, Jing Qiufang, Shen Yongjia, Ma Hongmei, Cui Jingbin

机构信息

Department of Pharmaceutical Engineering, School of Chemistry and Pharmaceutics, East China University of Science and Technology, Shanghai 200237, China.

出版信息

J Pharm Biomed Anal. 2006 May 3;41(2):549-53. doi: 10.1016/j.jpba.2005.11.041. Epub 2006 Jan 18.

Abstract

To evaluate the bioavailability of puerarin sustained release tablet (SR-Tab.) and Yufengningxin tablet (YU-Tab.), a liquid chromatography method was developed and validated to determine puerarin in dog plasma. Chromatographic separation was performed on Diamonsil C18 column using a mixture of methanol-acetic acid-water (25:6:69, v/v/v) delivered at a flow rate of 1.0 ml/min and detected by UV. 4-Hydroxybenzaldehyde was used as the internal standard. The linear range for puerarin was from 60 to 1800 ng/ml (r=0.9991) with a limit of quantitation of 60 ng/ml. Within-day accuracy and precision ranged from -3.0 to 2.2% and from 1.2 to 4.3%, between-day accuracy and precision ranged from -4.1 to 2.6% and from 1.3 to 5.7%, respectively. The mean extraction recoveries of puerarin determined over the three concentrations were (90.3+/-5.2)%, (95.7+/-1.4)% and (93.1+/-3.5)%. A significant difference was observed in main pharmacokinetic parameters of Tmax, Cmax and AUC0-infinity between puerarin SR-Tab. and YU-Tab. in dogs. The smoother plasma concentrations were obtained from SR-Tab. in dogs and the results were as expected.

摘要

为评价葛根素缓释片(SR-Tab.)与愈风宁心片(YU-Tab.)的生物利用度,建立并验证了一种液相色谱法用于测定犬血浆中的葛根素。采用Diamonsil C18柱进行色谱分离,以甲醇-乙酸-水(25:6:69,v/v/v)混合溶液为流动相,流速为1.0 ml/min,紫外检测。以4-羟基苯甲醛为内标。葛根素的线性范围为60~1800 ng/ml(r=0.9991),定量限为60 ng/ml。日内准确度和精密度范围分别为-3.0%至2.2%和1.2%至4.3%,日间准确度和精密度范围分别为-4.1%至2.6%和1.3%至5.7%。三个浓度下葛根素的平均提取回收率分别为(90.3±5.2)%、(95.7±1.4)%和(93.1±3.5)%。观察到葛根素缓释片与愈风宁心片在犬体内的主要药代动力学参数Tmax、Cmax和AUC0-∞存在显著差异。犬服用缓释片后血浆浓度更为平稳,结果符合预期。

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