1.Material Basis and Its Distribution in vivo of Qili Qiangxin Capsules Analyzed by UPLC-Q-Orbitrap-MS
Jianwei ZHANG ; Jiekai HUA ; Rongsheng LI ; Qin WANG ; Xinnan CHANG ; Wei LIU ; Jie SHEN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):185-193
ObjectiveBased on ultra-performance liquid chromatography-quadrupole-electrostatic field orbitrap high resolution mass spectrometry(UPLC-Q-Orbitrap-MS), the chemical constituents of Qili Qiangxin capsules was identified, and their distribution in vivo was analyzed. MethodsUPLC-Q-Orbitrap-MS was used to detect the sample solution of Qili Qiangxin capsules, as well as the serum, brain, heart, lung, spleen, liver and kidney tissues of mice after oral administration. Using the Thermo Xcalibur 2.2 software, the compound information database was constructed, and the molecular formulas of compounds corresponding to the quasi-molecular ions were fitted. Based on the information of retention time, accurate relative molecular mass and fragments, the compounds and their distribution in vivo were analyzed by comparing with the data of reference substances and literature. ResultsA total of 233 compounds, including 70 terpenoids, 60 flavonoids, 23 organic acids, 17 alkaloids, 20 steroids, 7 coumarins and 36 others, were identified or predicted from Qili Qiangxin capsules, 73 of which were identified matching with standard substances. Tissue distribution results showed that 71, 17, 38, 33, 32, 58 and 43 migrating components were detected in blood, brain, heart, lung, spleen, liver and kidney, respectively. Thirty-seven components were absorbed into the blood and heart, including quinic acid, benzoylaconitine benzoylmesaconine and so on. Fourteen components were absorbed into the blood and six tissues, including calycosin, methylnissolin, formononetin, alisol B, alisol A and so on. ConclusionThis study comprehensively analyzes the chemical components of Qili Qiangxin capsules and their distribution in vivo. Among them, astragaloside Ⅳ, salvianolic acid B, ginsenoside Rb1, ginsenoside Rb3, ginsenoside Rd, ginsenoside Rg3, calycosin-7-glucoside, and sinapine may be the important components for the treatment of heart failure, which can provide useful reference for its quality control and research on pharmacodynamic material basis.
2.Effects of Tongxinluo capsules on pharmacokinetics of rivaroxaban in rats
Guosheng FU ; Jie SHEN ; Jiekai HUA ; Yupeng SHAO ; Wenna MA ; Wei LIU ; Jianwei ZHANG ; Xinnan CHANG
China Pharmacy 2025;36(23):2930-2934
OBJECTIVE To investigate the impact of Tongxinluo capsules on the pharmacokinetics of rivaroxaban in rats. METHODS Rats were randomly divided into rivaroxaban alone group (2.70 mg/kg), low-dose Tongxinluo capsules combined with rivaroxaban group (Tongxinluo capsules 0.28 g/kg+rivaroxaban 2.70 mg/kg), and high-dose Tongxinluo capsules combined with rivaroxaban group (Tongxinluo capsules 0.84 g/kg+rivaroxaban 2.70 mg/kg), with five rats in each group. Following seven consecutive days of gavage with normal saline or the corresponding doses of Tongxinluo capsules, the rats were subjected to a final gavage administration of rivaroxaban. Blood samples were collected at 0 h prior to the final administration and at 0.16, 0.33, 0.50, 0.75, 1, 1.5, 2, 4, 8, 12 and 24 h post-final administration. The plasma concentration of rivaroxaban in rats was determined by high-performance liquid chromatography-tandem mass spectrometry. The pharmacokinetic parameters [peak concentration (cmax), half-life (t1/2), area under the drug concentration time curve (AUC), mean residence time (MRT), clearance (CL), apparent volume of distribution (Vd) and peak time (tmax)] of each group were calculated using a non-compartmental model of MonolixSuite 2023R1 pharmacokinetic software. RESULTS Compared with rivaroxaban alone group, AUC₀₋ₜ and AUC0-∞ of rivaroxaban in rats were increased significantly in high-dose Tongxinluo capsules+rivaroxaban group (P<0.05), while CL was decreased significantly (P<0.05); t1/2 and MRT were shortened, tmax was extended, cmax was increased, while Vd was decreased, but there was no statistical significance (P>0.05). CONCLUSIONS Rivaroxaban combined with Tongxinluo capsules significantly increases the plasma exposure of rivaroxaban in rats. Potential drug-drug interactions should be considered in clinical practice based on the co-administration conditions.

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