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1、HPLC法测定丹皮酚血浓度及其胶囊与片剂人体生物等效性研究作者作者单位武静山东大学齐鲁医院临床药理研究所,山东济南250012王本杰山东人学齐鲁医院临床药理研究所,山东济南250012魏春敏山东大学齐鲁医院临床药理研究所,山东济南250012孔祥麟山东大学齐鲁医院临床药理研究所,山东济南250012郭瑞臣山东大学齐鲁医院临床药理研究所,山东济南250012[ABSTRACT]Objective:ToestablishtheHPLCmethodfordeterminationofpaeonolinhumanplasmaandtoev
2、aluatethepharmacokineticparametersandthebioequivalenceofitscapsulesandtabletsinhealthyChinesevolunteers.Methods:Aliquorofplasmawascollectedatscheduledtimepointsbeforeandafterasingledoseof160?mgpaeonolwasorallygivento20healthyvolunteersinatwowaycrossoverdesigntest.Thep
3、lasmasampleswereextractedwith300?u1acetonitrile.ThepaeonolconcentrationinplasmawasdeterminedbyHPLCmethodusingaXBCl8(250?mmX4.6?mm,5?um)columnasastationaryphase,andTHFmethanolwaterphosphonicacid(6：60：34：0.1,V：V)asamobilephase.Thepharmacokineticparametersweredetermineda
4、ndthebioequivalenceofpaeonolcapsulesandtabletswasevaluatedwithDAS2.0.Results:Thelimitofdetectionforpaeonolwas10?ng/ml,andalinearityobtainedintherangeof10500?ng/mlwasexcellent(r=0.999?8).Therelativestandarddeviationsofintradayandinterdaydeterminationwerelessthan13.72%.
5、Themainpharmacokineticparametersofpaeonolafterasingleoraldoseof160mgpaeonolcapsulesandtabletswereasfollows:tl/2(h)1.03±0.35and1.09±0.62,Tmax(h)1.02±0.13and1.03±0.15,Cmax(ng/ml)116.39±45.57and111.16±41.24,AUC03(ng•h/ml)173.91±45.41and1.26±42.63,AUC0~(ng•h/ml)217.13±56.
6、55and220.27±67.24,respectively.Therelativebioavailabilityofpaeonolcapsuleswas(101.56±9.31)%.Conclusion:TheestablishedHPLCmethodishighlysensitiveandaccurate,andcanbesuccessfullyusedinthedeterminationofplasmapaeonolandisitspharmacokineticsstudies.Thepharmacokineticparam
7、eterofpaeonolshowsnosignificantdifferencesbetweencapsulesandtablets.Thetwopreparationsarebioequivalent.[KEYWORDS]Paeonol;Capsules;Tablets;Chromatography,Highpressureliquid丹皮酚(paeonol)是中药牡丹皮和徐长卿的主要活性成份，化学结构为2梵基4甲氧基乙酰苯,其熔点为5152?°C,正常状态下为白色针状晶体。微溶于水，能随水蒸气挥发，溶于乙醇、氯仿、苯等有机溶
8、剂。丹皮酚药理活性广泛，具有解热镇痛、抗炎、抗过敏、抗肿瘤、免疫调节以及改变血液流变学［1］等作用，而无镇痛依赖性和耐受性，毒副作用小。以往薄层色谱法［2］、毛细管电泳法［3］、毛细管气相色谱法［4］、HPLC法［5］多用于含丹皮酚药材及其制剂的丹
