Establishment and Development of a Quality Evaluation Method for Sangbaipi Decoction.

BACKGROUND: Sangbaipi decoction (SD), a traditional Chinese "Ancient Classical Prescription" consisting of eight medicinal materials, is usually used to treat asthma due to excess lung Qi and phlegm fire. OBJECTIVE: To establish a comprehensive quality evaluation method for SD. METHODS: HPLC fingerprint analysis, hierarchical cluster analysis (HCA), and principal component analysis (PCA) were applied for the quality control of SD prepared from different batches of medicinal materials. A total of 10 batches of SD samples were prepared and analyzed. RESULTS: A total of 24 common peaks and six active components (gardenoside, rutin, berberine, palmatine, baicalein, and wogonin) were identified in the HPLC fingerprint of SD. The ten batches of SD samples were divided into four groups via HCA and PCA. The HPLC fingerprint similarities of the 10 batch samples were 0.934 or higher. The precision, stability, repeatability, and other methodological indexes suggested that the developed method met the requirements for qualitative fingerprint research. CONCLUSION: The results indicated that HPLC fingerprints combined with PCA and multicomponent determination can be successfully applied to SD quality control. This study also provides a basis for a more comprehensive quality evaluation method for SD. HIGHLIGHTS: The fingerprint of SD, a TCM famous classical formula, was established by HPLC in this paper. Moreover, contents of six pharmacodynamic related components in SD were determined simultaneously in order to establish a comprehensive quality evaluation method of SD. This study can also provide a basis for raw material selection, quality evaluation, extraction process, preparation development and pharmacodynamic material basis research of SD.

Application of a new validated HPLC-DAD method for simultaneous determination of ten active components in Xiedu San.

In this research, a sensitive high-performance liquid chromatography-diode array detector (HPLC-DAD) method was established and validated for simultaneous detection of ten active constituents (gallic acid, catechin, berberine, palmatine, baicalin, baicalein, wogonin, rhein, emodin and chrysophanol) in Xiedu San, a traditional Chinese medicine compound preparation with effects of clearing away heat and toxic materials. The analysis was achieved on Agilent ZORBAX SB-C18 column (5µm, 250mm×4.6mm) with the temperature of 30°C. Gradient elution was applied using methanol (A)-0.1% phosphoric acid solution (B) as mobile phase at the flow rate of 1.0mL• min-1. The determination was performed at the wavelength of 225, 245, 278 and 348 nm along with the sample volume of 5µL. The tested constituents demonstrated good linear relationships within their respective determination ranges (r>0.9995). Average recoveries varied from 99.97% to 101.12% with RSDs of 0.71% to 1.92%. The contents of tested constituents ranged from 0.970 to 24.602 mg•g-1. The developed method was proved to be simple, accurate and sensitive, which can provide a quantitative analysis method for the quality evaluation and quality control of Xiedu San.

Simultaneous Determination of Eight Components in Leonuri Herba from Different Habitats by HPLC-DAD.

A HPLC-DAD method was established for the simultaneous determination of eight components in Leonuri Herba from different habitats, as well as providing methodological reference for quality control of Leonuri Herba. In this study, absolute ethanol extracts of the medicinal material were considered as the sample solutions to be analyzed. Agilent ZORBAX SB-C18 column (250 mm × 4.6 mm, 5 µm) was used for determination maintained at the temperature of 30°C. Gradient elution was performed with a mobile phase of methanol (B)-0.1% phosphoric acid solution (A) at the flow rate of 1.0 mL·min-1. The analysis was carried out at the wavelength of 225, 280 and 320 nm. The measured eight components showed good linear relationships within their own concentration range. Average recoveries ranged from 98.83 to 100.36% with RSDs of 1.14~1.97%. The proposed method was found to be simple, accurate and reproducible, which provided an effective quantitative analytical method for quality control of Leonuri Herba from different habitats.

Analysis of Antioxidant Capacity of Chromones in Saposhnikoviae Radix Obtained by Ultrasonic-Assisted Deep Eutectic Solvents Extraction.

In this paper, ultrasonic-assisted deep eutectic solvent (DES) extraction was applied to the acquisition of chromones (cimicifugin, prim-o-glucosylcimifugin, and 5-o-methylvisamminoside) from Saposhnikoviae radix (SR). The extraction effects of 11 prepared DESs were screened taking contents of chromones as indexes. Furthermore, the optimum extraction conditions were confirmed using a single-factor test and response surface optimization test. Scavenging activities of DPPH anion and ABTS cation radicals of different SR extracts (DES, methanol, and ethanol) were studied. The analysis results of best extraction conditions optimized by Design-Expert software were as follows: extraction time (40 min), extraction temperature (60°C), and the solid/liquid ratio (32 mL/g). Scavenging rates of the DES extract for DPPH anion radical and ABTS cation radical were found to be 75.31% and 65.71%, which were higher than those of methanol and ethanol extracts. In conclusion, the developed extraction method can be regarded as a safe, green, and more effective approach for the extraction of chromones in SR.

Simultaneous Determination of Six Active Components in Danggui Kushen Pills via Quantitative Analysis of Multicomponents by Single Marker.

In this paper, a valid evaluation method for the quality control of Danggui Kushen pills (DKP) has been established based on quantitative analysis of multicomponents by single marker (QAMS). Gallic acid, matrine, oxymatrine, catechin, ferulic acid, and rutin were selected as the indexes for quality evaluation of DKP. The analysis was achieved on an Agilent ZORBAX SB-C18 column (250 mm × 4.6 mm, 5 µm) via gradient elution. Gallic acid was used as internal standard to determine the relative correction factors (RCF) between gallic acid and other five constituents in DKP. The contents of those components were calculated at the same time. The accuracy of QAMS method was verified by comparing the contents of six components calculated by external standard (ES) method with those of the QAMS method. It turned out that there was no significant difference between the quantitative results of QAMS method and external standard method. The proposed QAMS method was proved to be accurate and feasible according to methodological experiments, which provided an accurate, efficient, and economical approach for quality evaluation of DKP.

Simultaneous Determination of Six Active Components in Oviductus Ranae via Quantitative Analysis of Multicomponents by Single Marker.

A method, quantitative analysis of multicomponents by single marker (QAMS), was established in this article to investigate the quality control of a traditional Chinese medicine, Oviductus Ranae. 7-Hydroxycholesterol, 7-ketocholesterol, 4-cholesten-3-one, stigmasterol, 7-dehydrocholesterol, and cholesterol were selected as the indexes of quality evaluation of Oviductus Rana. The determination was achieved on an Agilent HC-C18 column (4.6 mm × 250 mm, 5 µm) using methanol with water (87 : 13 v/v) as mobile phase at the flow rate of 2.0 mL/min. Cholesterol was used as an internal standard to determine the relative correction factors between cholesterol and other steroidal constituents in Oviductus Ranae. The contents of those steroidal constituents were calculated at the same time. To evaluate the QAMS method, an external standard method was used to determine the contents of six steroidal constituents. No significant difference was observed when comparing the quantitative results of QAMS with the results of external standard method. The proposed QAMS method was proved to be accurate and feasible based on methodological experiments. QAMS provided a simple, efficient, economical, and accurate way to control the quality of Oviductus Ranae.