Studies On The Toxicity, Pharmacodynamics And Quality Control Method Of SHENHUATONGMAI Capsules

Objective:To observe acute toxicity of SHENHUATONGMAI Capsule in mice and chronic toxicity of SHENHUATONGMAI Capsule in rats. Observe SHENHUATONGMAI Capsule on the microcirculation of prevention and treatment by acute blood stasis model. Determine the content of Sodium Danshensu in SHENHUATONGMAI Capsules by HPLC in order to establish the method of quality control.Methods:Acute toxicity test will participate in the original powder dubbed spend Capsule suspension, Crude drug equivalent dose0.333g/mL administered to mice for a week. After treatment, the mice were gross anatomy, organs found there when the volume, color, texture change, then changing the supply of organs for histopathological examination. Long-term toxicity tests in rats spent Capsule will participate in the original powder paired suspension, respectively, in low doses [0.33g/(kg·d)], medium dose [0.87g/(kg·d)] and high dose [2.36g/(kg·d)] administered to rats,7days a week straight a month to observe the rats hematologic indicators (including the clotting time, RBC, WBC, platelet count, WBC and hemoglobin content), urine routine, blood biochemical parameters (AST, ALT, Urea, Cr, CT) and the various organs (heart, liver, spleen, lung, kidney, adrenal gland, thyroid, testes or ovaries) and to carry out histopathological examination. SHENHUATONGMAI Capsules acute experimental rat model of blood stasis that with adrenaline and ice water stress caused by blood stasis in rats to observe the participants took capsules against the ear perfusion, cerebral blood flow top perfusion volume and perfusion of the mesenteric microcirculation changes in such indicators. Observation of the whole blood viscosity, plasma viscosity, hematocrit and fibrinogen. Observe the reduction in blood viscosity and determine RBC aggregation index, RBC deformation index, RBC rigidity index and RBC electrophoresis index. Use the TIANHE C18(200mm×4.6,5μm) column, its mobile phase was methanol0.15%acetic acid(10:90).The flow velocity was0.8mL-min-1and the detective wavelength of Sodium Danshensu was280nm,and the temperature of the column was room temperature.RESULTS:Acute toxicity test results in mice showed that the appearance of action in mice, reflex activity, water intake, large urinary conditions were normal. Compared with the control group, long-term toxicity tests in rats showed that participants spent three dose capsules against weight gain and general behavior of rats had no effect on activity; three hematology, urine and blood chemistry were measured no significant change. The major organs in rats treated group index and the control animals no significant difference. The histopathological examination showed the major organs in each group were non-toxic venereal reason to change. Experimental rats with acute blood stasis model of experimental results the ear, brain and mesenteric perfusion of microcirculation parameters are significantly increased in the acute blood stasis model (P<0.01). Microcirculation parameters of the whole blood viscosity, plasma viscosity, hematocrit and fibrinogen are significantly increased in the acute blood stasis model (P<0.01). SHENHUATONGMAI Capsule can improve blood stasis model:The ear, brain and mesenteric perfusion of microcirculation parameters have improved markedly and more obviously in high dose. The model index increase is most obvious in high doses. In the model, whole blood viscosity, plasma viscosity, hematocrit, and fibrinogen increased with high doses of more pronounced. It was showed that the Sodium Danshensu had a good linearity within the range of2.5-25mg/L, the average recovery was99.71%, and RSD=0.81%(n=6).Conclusions:Iavage can not spend Capsule measured parameters of the LD50, the drug use of safety tips. SHENHUATONGMAI Capsules equivalent to50times the clinical dose in rats given oral gavage doses of1month, no obvious toxicity. SHENHUATONGMAI Capsule has a good effect which improved the state of microcirculation and blood rheology in the acute blood stasis model. This method is simple and accurate for determination of Sodium Danshensu in SHENHUATONGMAI Capsules.