XiaoJin Capsule (XJC) is a classic Traditional Chinese Medicine formula for clinical treatment of thyroid nodules, mammary gland hyperplasia and breast cancer. For the specification and rational application of XJC in the future, an accurate and specific LC–MS/MS method was developed and validated for quantitative determination of five components in rat plasma after oral administration of XJC. The collected plasma samples were extracted by protein precipitation with methanol–acetonitrile (1:3, v/v) mixture solvent and separated on a C₁₈ column using a gradient elution system. Mass spectrometry was performed on a triple quadrupole mass spectrometer, and samples were detected in positive ionization and multiple reactions monitoring mode. The method was properly validated in terms of linearity, precision, accuracy, recovery, matrix effect and stability. All calibration curves showed good linearity (r² > 0.9910) over their concentration ranges. The intra‐ and inter‐day precisions (RSD) were within 11.0%, and the LLOQ was 0.1, 0.2, 0.5, 7.5 and 7.5 ng/ml for aconine, songorine, neoline, 3‐acetyl‐11‐keto‐β‐boswellic acid and 11‐keto‐β‐boswellic acid, respectively. Extraction recovery, matrix effect and stability were satisfactory in rat plasma. This established method was successfully applied to a pharmacokinetics study of five compounds after oral administration of XJC to normal and mammary gland hyperplasia model rats.

中文翻译：

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LC-MS / MS同时测定正常人和乳腺增生大鼠血浆中小金胶囊的五种生物活性成分及其在药代动力学研究中的应用

小金胶囊（XJC）是经典的传统中药配方，可用于临床治疗甲状腺结节，乳腺增生和乳腺癌。为了将来XJC的规范和合理应用，开发了一种准确而专一的LC-MS / MS方法，并经过验证可用于口服XJC后定量测定大鼠血浆中的五种成分。收集的血浆样品用甲醇-乙腈（1：3，v / v）混合溶剂通过蛋白沉淀法提取，并在C ₁₈上分离色谱柱使用梯度洗脱系统。在三重四极杆质谱仪上进行质谱分析，并以正电离和多反应监测模式检测样品。该方法在线性，精密度，准确性，回收率，基质效应和稳定性方面得到了正确验证。所有校准曲线 在其浓度范围内均显示出良好的线性（r ² > 0.9910）。日内和日间精密度（RSD）均在11.0％以内，并且乌头碱，松香碱，新碱，3-乙酰基-11-酮基-β-乳香的LLOQ为0.1、0.2、0.5、7.5和7.5 ng / ml酸和11-酮基β乳香酸。在大鼠血浆中的提取回收率，基质效应和稳定性令人满意。该建立的方法已成功地应用于正常和乳腺增生模型大鼠口服XJC后五种化合物的药代动力学研究。