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.

A review on analytical methods for natural berberine alkaloids

“…UHPLC‐Q‐TOF‐MS was also used in the detection of BAs (including jatrorrhizine, palmatine, and berberine) in Phellodendri amurensis cortex for QC at 220 nm and in the QC of Corydalis at 335 nm, where the capillary and cone voltages were 3 kV and 45 V, respectively . UHPLC‐Q‐TOF‐MS was also used for Chinese drug preparations of Sanhuang tablets . An Acquity UPLC BEH C18 column and a high‐resolution Q‐TOF‐MS were used as the detector with ESI in positive and negative modes for quantitative evaluation of alkaloids in Sanhuang tablets (including coptisine, epiberberine, jatrorrhizine hydrochloride, palmatine hydrochloride, and berberine hydrochloride).…”

“…An Agilent 6540 Q‐TOF mass spectrometer was used, and the peaks with the range of 100–1700 m/z were recorded. The separation speed, analysis efficiency, and sensitivity were clearly improved . A validated UHPLC‐ESI‐Q‐TOF/MS method was used for the drug metabolism analysis of traditional Chinese scutellaria‐coptis herb couple.…”

Novel applications of mass spectrometry‐based metabolomics in herbal medicines and its active ingredients: Current evidence

“…Thus, it is imperative to develop sensitive and high‐speed methods for herbal medicines analysis. The continuous innovation of various analytical techniques impels the research of herbal ingredients (Song et al, ; Fung et al, ; Cao et al, ). Although a broad range of instruments have been used to detect herbal ingredients, including CE, infrared spectroscopy, and Raman spectroscopy, only MS and NMR are routinely used.…”

Post-Harvest Processing Methods Have Critical Roles in the Contents of Active Ingredients of Scutellaria baicalensis Georgi

“…It has the qualities of clearing heat and drying moisture, halting bleeding, and relaxing the fetus [ 1 ]. Several traditional Chinese medicine prescriptions contain S. baicalensis , such as the Huangqin Qingre Chubi Capsule, the San Wu Huangqin Decoction, the Sanhuang Tablet, and the oral dose of Shuanghuanglian [ 2 , 3 , 4 , 5 ]. In recent medical research, S. baicalensis exhibits anti-inflammatory, anti-tumor, anti-bacterial, hypotensive, and anti-depressant properties [ 6 , 7 ].…”