西黄丸活性成分、药理作用研究进展及质量标志物预测分析

Review of Active Components and Pharmacological Effect and Prediction of Quality Markers of Xihuang Pills

摘要:

西黄丸是抗癌中成药的经典名方，遵循局部与整体相结合、祛邪和扶正相结合的理论原则，具有清热解毒、消肿散结之功效，传统多用于治疗火郁、痰瘀、热毒壅滞所致的痈疽疔毒、流注、乳岩、痰核、瘰疬、肺痈、肠痈等疾病，现代临床将其用于恶性肿瘤、乳腺增生、带状疱疹、淋巴结炎、盆腔炎包快、乳腺炎、声带白斑、痤疮等疾病的治疗及辅助治疗。西黄丸现收载于2020年版《中华人民共和国药典》，采用上等药材，结合现代技术工艺，充分保留了药物中的有效成分，其化学成分主要包括氨基酸、萜类化合物、脂肪酸、脂肪酸酯、酚类、胆汁酸、胆汁色素和挥发油等。现代药理研究表明，西黄丸中的胆红素、胆酸、乳香酸及挥发油等多种活性成分交互作用，可发挥抗肿瘤、抗乳腺增生、调节免疫功能、抗炎、调节神经内分泌功能等药理作用。该文对西黄丸活性成分、药理作用研究进展进行整理综述，并根据中药质量标志物（Q-marker）概念中的传递与溯源、特有性、有效性、可测性及复方配伍环境对西黄丸的质量标志物进行预测分析，提示胆红素、胆酸、牛磺酸、麝香酮、11-羰基-β-乳香酸、β-乳香酸、3-乙酰基-11-酮-β-乳香酸、乙酸辛酯、β-榄香烯、没药酮可作为西黄丸的质量标志物，可为西黄丸的物质基础及质量控制研究提供依据。

Abstract:

Xihuang pills are a classic Chinese patent medicine following the theoretical principle of combining eliminating pathogen with reinforcing healthy qi in both local areas and the whole body， with the effects of clearing heat， detoxifying， alleviating edema， and dissipating mass. This medicine is traditionally used for treating carbuncle， furuncle， multiple abscess， carcinoma of breast， phlegm nodule， scrofula， lung abscess， and intestine abscess caused by fire depression， phlegm stasis， and heat toxin stagnation. It is used for treating malignant tumors， breast hyperplasia， herpes zoster， lymphadenitis， pelvic inflammatory disease， mastitis， vocal cord leukoplakia， and acne in modern medicine. Xihuang pills are now included in the 2020 edition of the Chinese Pharmacopoeia. The use of high-quality medicinal materials and modern technology enables full retaining of the active components in the medicinal materials. The chemical components in this medicine mainly include amino acids， terpenoids， fatty acids， fatty acid esters， phenols， bile acids， bile pigments， and volatile oils. Modern pharmacological studies have shown that a variety of active components such as bilirubin， bile acid， boswellic acid， and volatile oil in Xihuang pills interact with each other to exert anti-tumor， anti-breast hyperplasia， immunomodulatory， anti-inflammatory， and neuroendocrine-regulating effect. This paper reviews the research progress in the active components and pharmacological effects of Xihuang pills and predicts the quality markers （Q-markers） of this medicine according to the transmission， traceability， specificity， efficacy， measurability， and compound compatibility in the concept of Q-marker. It is suggested that bilirubin， bile acid， taurine， muskone， 11-carbonyl-β-boswellic acid， β-boswellic acid， 3-acetyl-11-keto-β-boswellic acid， octyl acetate， β-elemene， and myrrhone can be used as Q-markers of Xihuang pills， which can provide a basis for research on the material basis and the quality control of Xihuang pills.