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目的:建立香丹注射液中丹参素(DSS)、原儿茶酸(PA)、原儿茶醛(PAL)在大鼠血浆中的HPLC分析方法,以间羟基苯甲酸为内标,研究香丹注射液中3种酚酸类成分在大鼠体内的药动学过程。方法:10%三氯乙酸沉淀蛋白,乙酸乙酯萃取,HPLC法测定不同时间点血浆中DSS,PA,PAL血药浓度,DAS2.0数据处理软件对数据进行统计学处理。结果:DSS在0.68~44.0 mg.L-1,PA在0.43~14.0 mg.L-1,PAL在0.38~12.0 mg.L-1具有良好的线性关系,平均回收率均大于92%,精密度和稳定性试验RSD 0.4%~4.8%;香丹注射液中丹参素、原儿茶酸、原儿茶醛均呈二室开放模型,其主要药动学参数分别为t1/2α(6.26±4.6),(5.93±4.9),(18.44±2.4)min;t1/2β(64.11±8.8),(63.28±0.13),(69.315±0)min;AUC0~∞(852.98±175.6),(83.84±58.8),(147.79±12.3)mg.min-1.L-1。结论:建立了香丹注射液中DSS,PA,PAL血药浓度的测定方法,该方法准确,灵敏,稳定性好,回收率高,且适用于其药动学的研究。
OBJECTIVE: To develop an HPLC method for the determination of Danshensu (DSS), protocatechuic acid (PA) and protocatechuic aldehyde (PAL) in Xiangdan injection in rats. Pharmacokinetics of Three Kinds of Phenolic Acids in Danshen Injection in Rats. Methods: The plasma concentrations of DSS, PA and PAL at different time points were determined by 10% trichloroacetic acid precipitated protein and extracted with ethyl acetate. The data were processed by DAS2.0 data processing software. Results: There was a good linear relationship between DSS of 0.68 ~ 44.0 mg.L-1, PA of 0.43 ~ 14.0 mg.L-1 and PAL of 0.38 ~ 12.0 mg.L-1.The average recoveries of DSS were more than 92% And RSD 0.4% -4.8%. Danshensu, protocatechuic acid and protocatechuic aldehyde in Xiangdan injection showed a two-compartment open model. The main pharmacokinetic parameters were t1 / 2α (6.26 ± 4.6 ), (5.93 ± 4.9) and (18.44 ± 2.4) min, respectively; t1 / 2β (64.11 ± 8.8), (63.28 ± 0.13), (69.315 ± 0) min; AUC0 ~ ∞ (852.98 ± 175.6) and (83.84 ± 58.8) ), (147.79 ± 12.3) mg.min-1.L-1. Conclusion: The method for determination of plasma concentration of DSS, PA and PAL in Xiangdan injection was established. The method is accurate, sensitive, good stability, high recovery and suitable for its pharmacokinetic study.