Salvianolic acid B is the main active ingredient in salvianolate injection, which is produced by extracting danshen, the most commonly used Chinese herbal medicine for cardiovascular treatment. Clinically, salvianolate injection and aspirin are commonly combined to treat coronary heart diseases in patients with stable angina. To support clinical studies on drug-drug interactions (DDIs) between salvianolate injection and aspirin, a rapid and sensitive UPLC-MS/MS method for the simultaneous determination of aspirin (acetylsalicylic acid), its metabolite salicylic acid, and salvianolic acid B in human plasma was developed. The analytes and internal standard were extracted from the acidified plasma by liquid-liquid extraction with ethyl acetate and then separated by gradient elution with acetonitrile/0.5% formic acid in water on a C18 column. Salvianolic acid B, acetylsalicylic acid, and salicylic acid were quantified in multiple-reaction monitoring mode with negative ion electrospray ionization. The method was fully validated according to the current regulatory guidance for bioanalysis. Calibration curves in the range 5–6000 ng/mL, all with correlation coefficients greater than 0.99, were established using linear regression models for salvianolic acid B and acetylsalicylic acid and a quadratic model for salicylic acid. The validated method was successfully used to measure salvianolic acid B, acetylsalicylic acid, and salicylic acid concentrations in human plasma samples from 16 patients to observe the pharmacokinetic changes caused by DDIs.

中文翻译：

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使用UPLC-MS / MS同时定量测定人血浆中的阿司匹林，其代谢产物水杨酸和丹酚酸B

丹酚酸B是丹酚酸酯注射液中的主要活性成分，它是通过提取丹参（一种用于心血管治疗的最常用中草药​​）而制成的。临床上，丹参多酚酸酯注射液和阿司匹林通常联合用于治疗稳定型心绞痛患者的冠心病。为了支持丹参多酚酸盐注射液和阿司匹林之间药物相互作用的临床研究，一种快速灵敏的UPLC-MS / MS方法，用于同时测定人体中的阿司匹林（乙酰水杨酸），其代谢产物水杨酸和丹酚酸B血浆被开发出来。通过用乙酸乙酯进行液-液萃取从酸化的血浆中萃取分析物和内标，然后在C18色谱柱上用乙腈/0.5%甲酸的水溶液进行梯度洗脱，进行分离。丹参酸B，乙酰水杨酸和水杨酸通过负离子电喷雾电离的多反应监测模式进行定量。该方法已根据当前的生物分析法规指南进行了充分验证。使用丹酚酸B和乙酰水杨酸的线性回归模型以及水杨酸的二次模型，建立了5–6000 ng / mL范围内的校正曲线，所有相关系数均大于0.99。验证的方法已成功用于测量16例患者血浆中丹酚酸B，乙酰水杨酸和水杨酸的浓度，以观察DDI引起的药代动力学变化。该方法已根据当前的生物分析法规指南进行了充分验证。使用丹酚酸B和乙酰水杨酸的线性回归模型以及水杨酸的二次模型，建立了5–6000 ng / mL范围内的校正曲线，所有相关系数均大于0.99。验证的方法已成功用于测量16例患者血浆中丹酚酸B，乙酰水杨酸和水杨酸的浓度，以观察DDI引起的药代动力学变化。该方法已根据当前的生物分析法规指南进行了充分验证。使用丹酚酸B和乙酰水杨酸的线性回归模型以及水杨酸的二次模型，建立了5–6000 ng / mL范围内的校正曲线，所有相关系数均大于0.99。验证的方法已成功用于测量16例患者血浆中丹酚酸B，乙酰水杨酸和水杨酸的浓度，以观察DDI引起的药代动力学变化。使用丹酚酸B和乙酰水杨酸的线性回归模型以及水杨酸的二次模型建立。验证的方法已成功用于测量16例患者血浆中丹酚酸B，乙酰水杨酸和水杨酸的浓度，以观察DDI引起的药代动力学变化。使用丹酚酸B和乙酰水杨酸的线性回归模型以及水杨酸的二次模型建立。验证的方法已成功用于测量16例患者血浆中丹酚酸B，乙酰水杨酸和水杨酸的浓度，以观察DDI引起的药代动力学变化。