title: Integrated LC-MS/MS Analytical Systems and Physical Inspection for the Analysis of a Botanical Herbal Preparation.
abstract: 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.
authors.affiliation: Institute of Traditional Medicine, School of Medicine, National Yang-Ming University, No. 155, Sec. 2, Li-Nong St, Beitou District, Taipei 11221, Taiwan. lancaster021@hotmail.com.
authors.forename: Kuan-Ming
authors.initials: KM
authors.lastname: Lai
authors.affiliation: Institute of Traditional Medicine, School of Medicine, National Yang-Ming University, No. 155, Sec. 2, Li-Nong St, Beitou District, Taipei 11221, Taiwan. vininecheng@gmail.com.
authors.forename: Yung-Yi
authors.initials: YY
authors.lastname: Cheng
authors.affiliation: Institute of Traditional Medicine, School of Medicine, National Yang-Ming University, No. 155, Sec. 2, Li-Nong St, Beitou District, Taipei 11221, Taiwan. thtsai@ym.edu.tw.|Graduate Institute of Acupuncture Science, China Medical University, No. 91, Hsueh-Shih Road, Taichung 40402, Taiwan. thtsai@ym.edu.tw.|School of Pharmacy, College of Pharmacy, Kaohsiung Medical University, No. 100, Shih-Chuan 1st Road, Kaohsiung 80708, Taiwan. thtsai@ym.edu.tw.|Department of Education and Research, Taipei City Hospital, No.145, Zhengzhou Rd., Datong Dist., Taipei 10341, Taiwan. thtsai@ym.edu.tw.
authors.forename: Tung-Hu
authors.initials: TH
authors.lastname: Tsai
mesh_terms: D002853:Chromatography, Liquid; D004365:Drugs, Chinese Herbal / Q000737:chemistry* / Q000592:standards*; D028321:Plant Preparations / Q000737:chemistry* / Q000592:standards*; D015203:Reproducibility of Results; D012995:Solubility; D053719:Tandem Mass Spectrometry
chemical_list: D004365:Drugs, Chinese Herbal; D028321:Plant Preparations
keywords: Traditional Chinese Medicine; herbal analysis; quality control; traditional  herbal formulation