血必净注射液大鼠体内的药动学研究

目的: 建立同时测定丹参素(DSS)、羟基红花黄色素A(HSYA)、芍药苷(PF)、阿魏酸(FA)血浆样品HPLC分析方法,研究血必净注射液中主要有效成分DSS、HSYA、PF、FA在大鼠体内的药代动力学。 方法: 尾静脉注射给药,不同时间采集血样,HPLC测定各成分血药浓度,用DAS 2.0软件拟合药时曲线,对药代动力学参数进行分析。 结果: DSS、HSYA、PF、FA的回收率均大于72%;日内、日间精密度RSD均小于6%;DSS、HSYA、PF、FA的t_1/2β分别为(12.206±4.211)min,(54.207±11.516)min,(23.397±8.553)min,(16.482±5.896)min;VF分别为(5.673±1.954)L·kg^-1,(0.587±0.375)L·kg^-1,(0.866±0.586)L·kg^-1,(21.263±2.698)L·kg^-1;CL分别为(0.237±0.093)L·min^-1,(0.020±0.005) L·min^-1,(0.033±0.009)L·min^-1,(1.707±0.364) L·min^-1。 结论: 该方法简便、准确,可用于血必净注射液的质量控制,适合多组分药代动力学研究,为血必净的临床用药提供依据。

Objective: To establish the HPLC method to analysis danshensu(DSS),hydroxysafflor yellow A(HSYA),paeoniflorin(PF),ferulic acid(FA) in plasma samples,and then study the pharmacokinetic process of Xuebijing injection in rat. Methods: The blood sample was collected at the different time after injected with vein of tail;The concentration of all compounds in the plasma sample were determined by the HPLC.The drug-time curve was fitted with the soft of DAS 2.0 to evaluate the pharmacokinetic parameters. Results: The recovery rate,the RSD of inter- and intra-day precision of all compounds were more than 72%,less than 6%,respectively.The pharmacokinetic parameters of DSS,HSYA,PF and FA were as follows:t_1/2β was (12.206±4.211) min,(54.207±11.516) min,(23.397±8.553) min,(16.482±5.896) min,respectively;VF was (5.673±1.954) L·kg^-1,(0.587±0.375) L·kg^-1,(0.866±0.586) L·kg^-1,(21.263±2.698) L·kg^-1,respectively;CL was (0.237±0.093) L·min^-1,(0.020±0.005) L·min^-1,(0.033±0.009) L·min^-1,(1.707±0.364) L·min^-1,respectively. Conclusion: This method is simple,accurate and successfully applied to the quality control,can provide the basis for clinical treatment and apply to the multi-components in the future.