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目的应用总量统计矩法研究丹红注射液主要有效成分丹参素、原儿茶醛、丹酚酸B和羟基红花黄色素A(HYSA)正交配伍对总量药动学参数的影响,研究复方内在配伍规律。方法以改良的线栓法复制大鼠大脑中动脉栓塞(MCAO)模型,采用正交试验法L_9(3~4)组成丹红注射液主要有效成分(丹参素、原儿茶醛、丹酚酸B、HYSA)用量配比不同的9个组方,供大鼠尾静脉iv给药,进行药动学研究。用DAS 3.2.6软件以非房室模型法拟合药动学参数,并进一步运用总量统计矩法计算总量药动学参数。应用正交分析法评价配伍对总量药动学参数的影响。结果丹红注射液主要有效成分丹参素、原儿茶醛、丹酚酸B和HYSA正交配伍对总量统计矩各参数影响不一,总量零阶矩AUC_t以丹参素水平的影响最大,且影响显著(P<0.05),最优组合为A_3B_3C_2D_1;总量一阶矩MRT_t以HYSA水平影响最大,最优组合为A_1B_3C_1D_1。结论总量统计矩可整合丹参素、原儿茶酸、香草酸、丹酚酸B、HYSA的药动学参数,表达各组方的整体药动学行为,中药复方多成分药动学可采用总量统计矩法进行研究,可为中药复方内在配伍规律研究提供方法。
OBJECTIVE: To study the effects of orthogonal design of total effective dose of Danshensu, protocatechuic aldehyde, salvianolic acid B and hydroxysafflor yellow A (HYSA) Research compound internal compatibility rules. Methods The model of middle cerebral artery occlusion (MCAO) in rats was established by the modified thread embolism method. The main active ingredients of Danshen injection (Danshensu, protocatechuic aldehyde, salvianolic acid B, HYSA) The dosage of 9 different prescriptions for the tail vein iv administration, pharmacokinetic studies. The pharmacokinetic parameters were fitted by DAS 3.2.6 software in a non-compartmental model and the total pharmacokinetic parameters were further calculated using the total statistical moment method. The influence of compatibility on total pharmacokinetic parameters was evaluated by orthogonal test. Results Danshensu, protocatechuic aldehyde, salvianolic acid B and HYSA were the main effective components of Danhong injection, and the parameters of total statistical moment had different effects. The total zero moment AUC_t had the greatest impact on the dosage of danshensu, (P <0.05), and the optimal combination was A_3B_3C_2D_1. The total first order moment, MRT_t, had the greatest effect on HYSA level, and the optimal combination was A_1B_3C_1D_1. Conclusion The total statistical moment can integrate the pharmacokinetic parameters of Danshensu, protocatechuic acid, vanillic acid, salvianolic acid B and HYSA, and express the overall pharmacokinetic behavior of each prescription. The multi-component pharmacokinetics of traditional Chinese medicine compound can be used The total statistical moment method can provide a method for studying the inherent compatibility of traditional Chinese medicine.