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目的:探讨通脉活络胶囊的制备及对血栓性疾病治疗的药理作用。方法:利用先进的生产工艺设备,对通脉活络胶囊的制备、工艺流程及质量控制进行研究,同时用动物实验的方法进行药理毒理探讨。结果:动物实验结果显示:通脉活络胶囊对凝血功能的影响:通脉活络胶囊0.50g/kg、1.00g/kg给药14d与正常对照组比较,有明显延长小鼠凝血及出血时间的趋势(P<0.05或P<0.01);通脉活络胶囊对血瘀大鼠血小板聚集率及凝血因子的影响比较:结果与正常组比较,模型组血液中TT、PT、APTT内源性和外源性凝血功能明显缩短,血小板聚集率显著增高;通脉活络胶囊0.20g/kg、0.40g/kg、0.80g/kg均能明显降低血瘀高凝大鼠模型Ⅱ因子活性,降低血小板聚集率,抑制内源性和外源性凝血系统,降低血液高凝状态,与模型组比较有明显差异(P<0.05或P<0.01)。结论:通脉活络胶囊的制备工艺简便,质量易于控制,对血栓性疾病治疗的药理作用明确,可安全应用于临床,取得显著的临床疗效。
Objective: To investigate the preparation of Tongmai Capsule and its pharmacological effects on the treatment of thrombotic diseases. Methods: Using advanced production technology and equipment, Tongmai active capsule preparation, process and quality control were studied, and the animal experiment method for pharmacological and toxicological studies. Results: The results of animal experiments showed that: Tongmai capsule on the coagulation function: Tongmai Capsule 0.50g / kg, 1.00g / kg administration 14d compared with the normal control group, there is a significant extension of the tendency of mice clotting and bleeding time (P0.05 or P0.01) .Comparison of the effect of Tongmai Huoluo Capsule on platelet aggregation rate and blood coagulation factor in blood stasis rats: Compared with the normal group, the levels of TT, PT, APTT in the model group were both endogenous and exogenous Tongmai Capsule 0.20g / kg, 0.40g / kg, 0.80g / kg can obviously reduce the activity of factor II in blood stasis and hypercoagulable rat model, reduce the rate of platelet aggregation, Inhibition of endogenous and exogenous coagulation system, reduce blood hypercoagulability, compared with the model group were significantly different (P <0.05 or P <0.01). Conclusion: Tongmai active capsule has the advantages of simple preparation process, easy control of quality, clear pharmacological action on the treatment of thrombotic diseases, safe application in clinic and remarkable clinical curative effect.