ABSTRACT
We established a quality evaluation method for Shuanghuanglian preparations based on an effect-constituent index (ECI), which is guided by the clinical efficacy of Shuanghuanglian and a dose-efficacy correlation. An HPLC method was used to establish the quantitative fingerprint of Shuanghuanglian from different manufacturers and to determine the content of 10 fingerprint components, including baicalin, chlorogenic acid, forsythin, galuteolin, wogonin, forsythoside A, luteolin, caffeic acid, baicalein, and scutellarin. Using Staphylococcus aureus as biological model, the potency of Shuanghuanglian preparations was determined by antibiotic microbial assay. Using the method of PLC-DA, the efficacious antibacterial components were screened by "dose-efficacy" correlation analysis. According to the antibacterial potency and content of the antibacterial ingredients, combined with the method of the custom weight coefficient, ECI was calculated and verified. The results show that the antibacterial ECI can facilitate evaluation of the efficacy of Shuanghuanglian based on the composition of its contents, providing a new method for the quality control of traditional Chinese medicine.
ABSTRACT
Testing and analysis of chemical markers is currently the prevailing approach for quality assessment of traditional Chinese medicines. However,several important issues remain to be addressed,including the trade-off between accuracy and coverage. In this study,in order to give full play to the advantages of their respective methods and provide technical support for more comprehensively and rapidly evaluate the quality of Danshen Injection products,a fingerprint method was coupled with quantitative analysis of multicomponents by single marker( QAMS),with Danshen Injection as the carrier. Ultra performance liquid chromatography( UPLC) was used to establish the quantitative fingerprint. The UPLC fingerprints contained 13 common peaks,11 of which were identified by using ultra performance liquid chromatography-quadrupole time-of-flight mass spectrometry( UPLC-QTOF-MS). Furthermore,with sodium danshensu as the internal reference substance,relative correction factors( RCFs) of protocatechuic aldehyde,caffeic acid,rosmarinic acid,lithospermic acid,and salvianolic acid B were calculated through slope analysis method,and the QAMS method was adopted to determine the contents of these 6 components. The UPLC fingerprint was employed to assess the consistency of 12 batches of Danshen Injection,which showed good batch-to-batch consistency with similarity higher than 0. 99. In the comparison of contents of the six constituents obtained by QAMS and external standard method( ESM),RSD was all less than 4. 3%,indicating the good accuracy of the QAMS method. The QAMS method developed in this study combined with UPLC fingerprint can comprehensively reflect the internal quality of Danshen Injection when only the reference substance sodium danshensu is consumed,with greatly reduced detection cost and time. It provides a technical basis for further improving the quality standard of Danshen Injection.
Subject(s)
Chromatography, High Pressure Liquid , Drugs, Chinese Herbal , Reference Standards , Injections , Mass Spectrometry , Quality Control , Salvia miltiorrhiza , ChemistryABSTRACT
Objective To establish a HSDE-HPLC-DAD-ESI-TOF/MS method for the rapid identification of chemical ingredients for Chaenomeles thibetica, and establish the multi-component quantitative fingerprint to evaluate its quality. Methods The separation was developed via an Agilent Zorbax SB-C18 column (250 mm × 4.6 mm, 5.0 μm) with a gradient elution at a temperature of 25 ℃, the acetonitrile was used as the mobile phase A and 0.5% glacial acetic acid and 10 mM ammonium acetate solution was used as the mobile phase B with a flow rate of 0.8 mL/min, and the detection wavelength was 280 nm. ESI-TOF/MS was used for the identification of chemical ingredients in C. thibetica. The fingerprint of C. thibetica was established based on the quantitative detection of multi-components. Results The HPLC fingerprint of C. thibetica has 30 common peaks, nine ingredients (chlorogenic acid, vanillic acid, caffeic acid, veratric acid, rutin, quercitrin, hyperin, oleanolic acid, and uosolic acid) of C. thibetica were identified, and the contents of them were determined. Similarity analysis shows that the similarity of 10 batches of C. thibetica is relatively close, while the similarity between C. thibetica and other varieties' is quite different. Conclusion HSDE-HPLC-DAD-ESI-TOF/MS method can be used for the rapid extraction and analysis of C. thibetica fresh samples. On this basis, the fingerprint analysis combined with similarity analysis can be used for quality evaluation of C. thibetica.
ABSTRACT
The present study was designed to establish a multi-wavelength quantitative fingerprinting method for San-Huang Tablets (SHT), a widely used and commercially available herbal preparation, where high performance liquid chromatography (HPLC) with a diode array detector (DAD) was employed to obtain the fingerprint profiles. A simple linear quantitative fingerprint method (SLQFM) coupled with multi-ingredient simultaneous determination was developed to evaluate the quality consistency of the tested samples qualitatively and quantitatively. Additionally, the component-activity relationship between chromatographic fingerprints and total radical-scavenging capacity in vitro (as assessed using the 1, 1-diphenyl-2-picrylhydrazyl (DPPH) assay) was investigated by partial least squares regression (PLSR) analysis to predict the antioxidant capacity of new samples from the chromatographic fingerprints and identify the main active constituents that can be used as the target markers for the quality control of SHT. In conclusion, the strategy developed in the present study was effective and reliable, which can be employed for holistic evaluation and accurate discrimination for the quality consistency of SHT preparations and other traditional Chinese medicine (TCM) and herbal preparations as well.