Identification of Q-Markers from Hedan Tablet by employing “spiderweb”mode and taking compounds'hepatotoxicity into account

Objective Due to the complicated compounds and the synergistic effect of multi-compounds,the quality control and assessment of Chinese materia medica(CMM)encounters a great challenge about how to identify the key compounds,which are directly correlated with its efficacy and safety.On the guidance of study on quality marker(Q-Marker),identification of Q-Markers was performed from Hedan Tablet(HDT)by the aid of the“spider-web”mode and hepatotoxicity evaluation derived from our previous researches and literatures.Methods By the established ultra performance liquid chromatography with photodiode array detector(UPLC-PDA)method,online UPLC-DPPH·and offline antioxidant assay,21 candidate compounds of HDT were systematically investigated and comprehensively evaluated by the“spider-web”mode for them properties of Q-Marker based on“content-stability-activity”.In addition,the Q-Markers related with hepatotoxicity based on our previous researches and literatures were identified.Results Salvianolic acid B(SaB),quercetin-3-O-glucuronide(Qug),isoquercitrin(IQ)and hyperoside(Hyp)were adopted as the preferable Q-Markers of HDT according to the shaded area(A)of tested compounds in“spider-web”mode.Psoralen(Ps),isopsoralen(IP),psoralenoside(PO)and isopsoralenoside(IPO)were also strongly recommended as Q-Markers closely related with safety by considering hepatotoxicity of the accumulated Ps and IP and conversion between glycoside(PO and IPO)and aglycone(Ps and IP).Conclusion This study provided scientific evidence for quality control and assessment of HDT,and also provided a meaningful reference for application of Q-Markers in CMM.

Effects of Hedan Tablet(荷丹片)on Lipid Profile, Proprotein Convertase Subtilisin/Kexin Type 9 and High-Density Lipoprotein Subfractions in Patients with Hyperlipidemia:A Primary Study

Objective： To investigate the effects of Hedan Tablet（荷丹片） on serum lipid profile, proprotein convertase subtilisin/kexin type 9（PSCK9） and high-density lipoprotein（HDL） subfractions in patients with hyperlipidemia. Methods： Thirty-seven patients with hyperlipidemia were randomized to treatment with Hedan Tablet 4.38 g/day as Hedan group（18 cases） or placebo（19 cases） as control group for 8 weeks. The lipid profile, PCSK9 and HDL subfractions were determined at day 0 and week 8 in both groups respectively. Results： Hedan treatment for 8 weeks mildly decreased serum low-density lipoprotein cholesterol（LDL-C） levels, while no changes were found in total cholesterol（TC）, triglycerides（TG） and PCSK9 concentrations. Furthermore, Hedan treatment increased the concentration of large high-density lipoprotein cholesterol（HDL-C） and the percentage of large HDL subfraction, while decreased the concentration of small HDL-C and the percentage of small HDL subfraction without changing serum HDL-C levels in patients with hyperlipidemia. Conclusion： Hedan treatment of 4.38 g per day for 8 weeks could confer a favorable effects on serum LDL-C concentration as well as HDL subfractions.