Lai Kuan-Ming, Cheng Yung-Yi, Tsai Tung-Hu
Institute of Traditional Medicine, School of Medicine, National Yang-Ming University, No. 155, Sec. 2, Li-Nong St, Beitou District, Taipei 11221, Taiwan.
Graduate Institute of Acupuncture Science, China Medical University, No. 91, Hsueh-Shih Road, Taichung 40402, Taiwan.
Molecules. 2015 Jun 9;20(6):10641-56. doi: 10.3390/molecules200610641.
The herbal decoction process is generally inconvenient and unpleasant. To avoid using herbal medicine decoctions, various high-quality industrial and pharmaceutical herbal decoction products have been used in clinical applications for more than ten years in Taiwan. However, the consistency and standardization of the quality of these herbal medicines are goals that remain to be achieved. The aim of study was to develop a validated liquid chromatography-tandem electrospray ionization mass spectrometry (LC-MS/MS) method to determine the biomarkers astragaloside I, astragaloside IV, formononetin, cinnamic acid, paeoniflorin and gingerol in the herbal preparation known as Huangqi-Guizhi-Wuwu (HGW). To investigate the physical quality of HGW, methods such as scanning electron microscopy, light microscopy with Congo red and potassium iodine staining, solubility measurements, swelling power tests, and crude fiber analysis were used to identify additives in commercial pharmaceutical products. The optimal LC-MS/MS multiple reaction-monitoring system included a gradient program using 5 mM ammonium acetate buffer with 0.05% formic acid/methanol. The results demonstrate deviations in biomarker content across different brands. In addition to the herbal extract, starch and excipients in the pharmaceutical granule, and crushed crude herb powder was added to the pharmaceutical products to increase their herbal ingredient content. In conclusion, a rigorous examination should be performed to certify the quality of the herbal products.
中药汤剂的制备过程通常不方便且令人不适。为避免使用中药汤剂，台湾临床应用各种优质的工业和药用中药汤剂产品已有十多年。然而，这些中药质量的一致性和标准化仍是有待实现的目标。本研究的目的是开发一种经过验证的液相色谱 - 串联电喷雾电离质谱（LC-MS/MS）方法，以测定名为黄芪桂枝五物汤（HGW）的中药制剂中的生物标志物黄芪苷I、黄芪苷IV、芒柄花素、肉桂酸、芍药苷和姜辣素。为研究HGW的物理质量，采用扫描电子显微镜、刚果红和碘化钾染色的光学显微镜、溶解度测量、膨胀力测试和粗纤维分析等方法来鉴定市售药品中的添加剂。最佳的LC-MS/MS多反应监测系统包括一个梯度程序，使用含0.05%甲酸/甲醇的5 mM醋酸铵缓冲液。结果表明不同品牌的生物标志物含量存在差异。除了草药提取物外，药物颗粒中的淀粉和赋形剂，以及粉碎的生药粉末被添加到药品中以增加其草药成分含量。总之，应对草药产品的质量进行严格检查。
