| Objectives: To establish the quality control methods of chromatographic fingerprints of roots of Salvia yunnanensis C. H. Wright (S. yunnanensis), and identify the main chromatographic peaks with HPLC-MS, from the level of the chemical composition comparing similarities and differences with the roots of Salvia miltiorrhiza Bge. (S. miltiorrhiza). A hydrogen peroxide-induced injury of vascular endothelial cells is used as a model to explore S. yunnanensis and S. miltiorrhiza and the compatibility of them to the total saponins of Panax notoginseng (TSPNS) to demonstrate their different antioxidant capacities, from the Pharmacology of the cell level comparing their similarities and differences. S. yunnanensis extraction, purification and screening of new excipients is studied, and with it compressing to Preparation Zidan Huoxue, an orally disintegrating tablet, offers special patients such as those unconscious after stroke and dysphagia, a new quicker-effect option for treatment.Methods: Collection of S. yunnanensis of different origins. The effect of the major fingerprint factors such as the mobile phase, column, the extraction and other factors were studied. S. yunnanensis main peaks features were identified, using a HPLC-MS method. Also using the same conditions S. Miltiorrhiza fingerprints were identified for comparison. A hydrogen peroxide-induced injury in cultured human umbilical vein endothelial cells was used to detect protective effects by MTT method, to analyze cell division cycle by flow cytometry techniques. This clarifies the pharmacological effects of S. yunnanensis and S. Miltiorrhiza and them to TSPNS compatibility ratios. S. yunnanensis extraction and purification was studied to produce suitable raw materials and identify auxiliary materials passing through the screening and so acheive compression into orally disintegrating tablets.Results: Identification of S. yunnanensis fingerprints of hydrophilic and hydropholic components with high reproducibility, specificity and Congruity. There is a big difference in the comparison of the hydrophilic components of the fingerprints of the size and number of the peaks obtained with S. yunnanensis and S. Miltiorrhiza. S. yunnanensis fingerprints feature relatively more peaks, although the peak areas have relatively small differences. In the S. Miltiorrhiza fingerprints, Salvianolic Acid B, shows "a large-independence" and has other feature peaks with less volumes. With the S. yunnanensis hydropholic components fingerprints compared with S. Miltiorrhiza, the number of peaks are basically similar, but the peaks in volume "peak area" show big differences.Protective effect of the S. yunnanensis total phenol acid (TPA) on the damaged vascular endothelial cells is stronger than S. Miltiorrhiza TPA. In the groups of different ratios of S. yunnanensis and S. Miltiorrhiza to TSPNS, when the ratio value of S. Miltiorrhiza to TSPNS is 1∶1 and 2∶1, the protective effect is more stronger.In S. yunnanensis TPA extraction and purification processes, the process temperature is a key factor of Salvianolic Acid B transfer rates. By regulating the pH in extraction the process can be effective in reducing the rate of dry extract. By this process, the S. yunnanensis TPA, can meet orally disintegrating tablet formulations requirements. When the ratio of MCC: PVPP: L-HPC is 26∶5.3∶2.7, and the amount of prescription is 74%, by compression molding, the finished product meets orally disintegrating tablet quality requirements.Conclusions: The S. yunnanensis fingerprints have high reproducibility, specificity and congruity. This means the method can be used as a new quality control in S. yunnanensis. S. yunnanensis and S. Miltiorrhiza hydrophilic components show large differences, providing a material basis for a reasoned explanation that the S. yunnanensis pharmacological effect is stronger than or equivalent to S. Miltiorrhiza. Through a comparison of the two, there is indication of a need for further study of the S. yunnanensis chemical constituents. We find protection activity of S. yunnanensis TPA on injury cell was stronger than the effect of S. Miltiorrhiza TPA. It is found that when the Value ratio of S. Miltiorrhiza TPA to TSPNS is 2∶1 and 1∶1, the protective effect is more stronger, and stronger than groups of S. yunnanensis TPA to TSPNS. This shows S. Miltiorrhiza TPA significantly improved their disadvantage of single component, and strengthened the short-term role, the proportion of compatibility provides basis for clinical application. We find that the activity order of S. yunnanensis TPA to TSPNS is 1∶2＞1∶1, 2∶1. This discovery is significant to the full use and protection of the resources of S. yunnanensis, because S. yunnanensis comes from wild plant, its resources is scarce, The discovery lay the foundation that a small amount of S. yunnanensis compatibility can play a greater role. S. yunnanensis in controlled extraction and purification, can be presented in an orally disintegrating tablet. In this presentation, the tablet rapidly disintegrated and thus provides a new treatment for special patients.In the S. yunnanensis study of this dissertation, it is the first time this has been recorded.
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