title: Comprehensive Quantitative Analysis of 32 Chemical Ingredients of a Chinese Patented Drug Sanhuang Tablet.
abstract: Sanhuang Tablet (SHT) is a Chinese patented drug commonly used for the treatment of inflammations of the respiratory tract, gastrointestinal tract, and skin. It contains a special medicinal composition including the single compound berberine hydrochloride, extracts of Scutellariae Radix and Rhei Radix et Rhizoma, as well as the powder of Rhei Radix et Rhizoma. Despite advances in analytical techniques, quantitative evaluation of a Chinese patented drug like SHT remains a challenge due to the complexity of its chemical profile. In this study, ultra-high performance liquid chromatography coupled with quadrupole-time-of-flight mass spectrometry (UHPLC-Q-TOF-MS) was used to simultaneously quantify 29 non-sugar small molecule components of SHT (11 flavonoids, two isoflavonoids, one flavanone, five anthraquinones, two dianthranones, five alkaloids, two organic acids and one stilbene). Three major saccharide components, namely fructose, glucose, and sucrose, were also quantitatively determined using high performance liquid chromatography-charged aerosol detector (HPLC-CAD) on an Asahipak NH₂P-50 4E amino column. The established methods were validated in terms of linearity, sensitivity, precision, accuracy, and stability, and then successfully applied to analyze 27 batches of commercial SHT products. A total of up to 57.61% (w/w) of SHT could be quantified, in which the contents of the determined non-saccharide small molecules varied from 5.91% to 16.83% (w/w) and three saccharides accounted for 4.41% to 48.05% (w/w). The results showed that the quality of the commercial products was inconsistent, and only four of those met Chinese Pharmacopoeia criteria.
authors.affiliation: School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, China. 15485862@life.hkbu.edu.hk.
authors.forename: Hau-Yee
authors.initials: HY
authors.lastname: Fung
authors.affiliation: First Affiliated Hospital, Zhengzhou University, Zhengzhou 450001, China. graduately@163.com.
authors.forename: Yan
authors.initials: Y
authors.lastname: Lang
authors.affiliation: School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, China. alanhhm@hkbu.edu.hk.
authors.forename: Hing-Man
authors.initials: HM
authors.lastname: Ho
authors.affiliation: School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, China. 15485021@life.hkbu.edu.hk.
authors.forename: Tin-Long
authors.initials: TL
authors.lastname: Wong
authors.affiliation: Department of Chemistry, Hong Kong Baptist University, Hong Kong, China. edmondma@hkbu.edu.hk.
authors.forename: Dik-Lung
authors.initials: DL
authors.lastname: Ma
authors.affiliation: State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China. duncanleung@umac.mo.
authors.forename: Chung-Hang
authors.initials: CH
authors.lastname: Leung
authors.affiliation: School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, China. simonhan@hkbu.edu.hk.
authors.forename: Quan-Bin
authors.initials: QB
authors.lastname: Han
mesh_terms: D000470:Alkaloids / Q000737:chemistry / Q000302:isolation & purification; D002851:Chromatography, High Pressure Liquid; D004365:Drugs, Chinese Herbal / Q000032:analysis / Q000737:chemistry*; D005419:Flavonoids / Q000737:chemistry / Q000302:isolation & purification; D006801:Humans; D007249:Inflammation / Q000188:drug therapy* / Q000473:pathology; D008518:Medicine, East Asian Traditional; D027343:Rhizome / Q000737:chemistry; D031364:Scutellaria baicalensis / Q000737:chemistry; D013607:Tablets / Q000032:analysis / Q000737:chemistry*; D053719:Tandem Mass Spectrometry
chemical_list: D000470:Alkaloids; D004365:Drugs, Chinese Herbal; D005419:Flavonoids; D013607:Tablets; C532979:sanhuang
keywords: CAD; Chinese patented drug; quality evaluation; quantitative analysis; sanhuang tablet