[Quality analysis of Xueshuan Xinmaining Tablets and Capsules based on UPLC-Q/TOF-MS and UPLC-QQQ-MS/MS]

Xueshuan Xinmaining Tablets and Capsules are two Chinese patent medicines with the same prescription, different preparation methods but the same function of replenishing Qi, activating blood, opening orifices, and relieving pain. Xueshuan Xinmaining Capsules were qualitatively analyzed by UPLC-Q/TOF-MS for the first time, and 61 compounds were identified, including 9 phenolic acids, 10 bufadienolides, 15 saponins, 5 bile acids, and 22 other compounds. The chemical composition was slightly different between Xueshuan Xinmaining Tablets and Capsules. On this basis, network pharmacology was employed to construct the component-target-pathway network, which clarified 36 active ingredients and 31 common targets of the tablets and capsules for treating coronary heart disease, angina pectoris, and ischemic stroke. A method was developed based on UPLC-QQQ-MS/MS for determining the content of bufadienolides including gamabufotalin, arenobufagin, bufotaline, bufalin, cinobufagin, and resibufogenin. The average recoveries of the six components were 80.84%, 98.65%, 104.6%, 102.7%, 83.46%, and 104.9%, respectively. The content of the six components was 4.13-10.3, 20.6-57.9, 11.0-32.2, 9.52-22.7, 1.64-3.39, and 11.3-19.5 μg·g~(-1) in 10 batches of Xueshuan Xinmaining Tablets and 0.647-5.36, 2.69-72.1, 2.05-17.6, 2.14-24.2, 1.19-7.58, and 2.71-21.8 μg·g~(-1) in 15 batches of Xueshuan Xinmaining Capsules, respectively. The results showed that the content of six components varied in the samples of different dosage forms, different manufacturers, and different batches. This study clarified the chemical composition of Xueshuan Xinmaining Tablets and Capsules and predicted the active ingredients, common targets, and signaling pathways for the treatment of coronary heart disease, angina pectoris, and ischemic stroke by network pharmacological methods. The findings laid a foundation for clarifying the pharmacodynamic substances and provided testing methods for improving the quality standards and quality control of Xueshuan Xinmaining Tablets and Capsules. It is recommended that attention should be paid to the quality of toad venom in the production process of Xueshuan Xinmaining Tablets and Capsules.