【摘要】 目的：测定桑葛降脂丸4种主成分含量；研究桑葛降脂丸在大鼠体内的药代动力学变化规律。方法：基于HPLC法同时测定桑葛降脂丸中没食子酸、绿原酸、葛根素和丹酚酸B这4种成分的含量；采用LC-MS法测定大鼠灌胃桑葛降脂丸溶液后血浆中绿原酸和葛根素的浓度。结果：没食子酸、绿原酸、葛根素和丹酚酸B分别在质量浓度1.7～17.4、7.3～72.7、40.0～395.9、16.0～160.4 mg·L^-1时与峰面积呈良好线性关系，相关系数r分别为0.9991、0.9992、0.9999、0.9993，平均回收率分别为98.2%、100.5%、99.8%、100.4%,RSD分别为0.9%、1.9%、0.2%和0.4%，精密度、重复性、稳定性及耐用性的RSD均小于2.0%；绿原酸和葛根素血浆质量浓度分别在3～1300 ng·mL^-1、5～1800 ng·mL^-1时线性良好，提取回收率为83.3%～94.2%，基质效应为80.7%～98.8%，日内及日间精密度、准确度和稳定性良好。结论：建立的4种成分含量测定的HPLC分析方法，其精密度、重复性良好，方法稳定可靠，可用于桑葛降脂丸的质量控制；建立的LC-MS方法简便、灵敏、特异性高，可用于大鼠灌胃桑葛降脂丸溶液后绿原酸和葛根素的药代动力学研究。更多还原

【Abstract】 Objective:To determine the content of four main components in Sangge Jiangzhi pill, and to investigate the pharmacokinetic changes of Sangge Jiangzhi pill in rats. Methods:The contents of gallic acid, chlorogenic acid, puerarin, and salvianolic acid B in Sangge Jiangzhi pill were determined by HPLC. Plasma chlorogenic acid and puerarin concentrations were determined by LC-MS after the rats were intragastric administration of the Sangge Jiangzhi pill solution. Results:It showed a good linear relationship with the peak area for gallic acid, chlorogenic acid, puerarin, and salvianolic acid B at the mass concentration of 1.7-17.4, 7.3-72.7, 40.0-395.9 and 16.0-160.4 mg·L-1, respectively. The correlation coefficients r were 0.9991, 0.9992, 0.9999 and 0.9993, respectively. The average recoveries were 98.2%, 100.5%, 99.8% and 100.4%, and RSDs were 0.9%,1.9%,0.2%and 0.4%,respectively.RSDs of precision,repeatability,stability,and durability were all less than 2.0%.The plasma concentrations of chlorogenic acid and puerarin were in the range of 3-1300 and 5-1800ng·mL-1,the extraction recovery was in the range of 83.3%-94.2%,the matrix effect was in the range of 80.7%-98.8%,and the intraday and interday precision,accuracy and stability were all good.Conclusion:The HPLC method for the content determination of four components shows good precision,repeatability,stability and reliability,which can be used for the quality control of Sangge Jiangzhi pill.The established LC-MS method is simple,sensitive,and highly specific,which can be used to the pharmacokinetic study of chlorogenic acid and puerarin in rats after intragastric administration of the Sangge Jiangzhi pill solution.更多还原