Ren Fuzheng, Jing Qiufang, Shen Yongjia, Ma Hongmei, Cui Jingbin
Department of Pharmaceutical Engineering, School of Chemistry and Pharmaceutics, East China University of Science and Technology, Shanghai 200237, China.
J Pharm Biomed Anal. 2006 May 3;41(2):549-53. doi: 10.1016/j.jpba.2005.11.041. Epub 2006 Jan 18.
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.
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。
