mechanisms of ASEP against cardiovascular diseases, and provided useful insights for future integrated PK study on anti-cardiovascular diseases TCM injections.

This paper reported a feasibility study strategy of identifying pharmacokinetic (PK) markers for a cardiovascular herbal medicine, Guanxin Danshen drop pill (GDDP). First, quantification analysis revealed the constituent composition in the preparation by high-performance liquid chromatography (HPLC). Subsequently, physiochemical property calculation predicted the solubility and intestinal permeability of the constituents in the preparation. Furthermore, HPLC–MS analysis ascertained the absorbable ingredients and their PK properties in rat plasma. The main effective substances from the ingredients absorbed into blood and their cardiovascular effects were also predicted by systems pharmacology study, and were further confirmed by in vivo protective effects on isoprenaline-induced myocardial injury in mice. Finally, the ingredients with high content, representative structure feature, favorable PK properties, high relevant degree to myocardial ischemia (MI) issues, and validated therapeutic effects were considered as the PK markers for the preparation. Ginsenosides Rg1, Rb1, and tanshinone (TS) IIA were identified originally as PK markers for representing PK properties of GDDP. In addition, integrated PK studies were carried out according to previous reports, viz. drug concentration sum method and the AUC weighting method, to understand the in vivo process of GDDP comprehensively. The present study maybe provide a reference approach to identify PK markers for cardiovascular herbal medicines.

Background: Ciwujia injection, prepared from water extraction of Acanthopanax senticosus, is widely used for the treatment of cardiovascular diseases in the clinic in China. The ingredients of the preparation are still not efficiently clear and its quality control method requires further improvement. </P><P> Objective: In this paper, the qualitative and quantitative methods for quality control of Ciwujia injection were originally developed by a combination of HPLC-Q-TOF-MS, HPLC-TQ-MS/MS and UPLCPDA. Methods: With HPLC-Q-TOF-MS and HPLC-TQ-MS/MS, compounds were identified firstly by comparison of their MS spectra and retention times with those of standards or recorded information in the literature. Further, a new UPLC-PDA method was originally established to simultaneously determine the multiple ingredients in the preparations. Results: For qualitative analysis, 22 compounds were identified by the presented method. For quantitative analysis, the validated method exhibited good linearity (R2 > 0.998), repeatability (RSD < 1.50%), intra- and inter-day precisions (RSD < 8.33%) and recoveries (95.93-108.58%) for the simultaneous determination of the active ingredients, including protocatechuic acid-3-glucoside, l-phenylalanine, protocatechuic acid, neochlorogenic acid, chlorogenic acid, gentiopicroside, eleutheroside B, and cryptochlorogenic acid, and was successfully utilized to analyze the eight compounds in 4 batches of Ciwujia injection. Conclusion: The presented method is simple and rapid for quality control of Ciwujia injection, and could provide a useful reference for the quality control and routine analysis of others Ciwujia preparations.