目的:研制伤筋活血合剂,观察该合剂对踝关节骨折和挠骨下端骨折的临床疗效。方法:建立该合剂的质量控制方法;将踝关节骨折和挠骨下端骨折二组病人随机分组,分别用伤筋活血合剂和相应对照药物治疗,观察疗效。结果:伤筋活血合剂制备工艺简单,质量可靠,性质稳定。在相同时间内治疗组疗效优于对照组,在 4～6周期间治疗组与对照组经统计学处理有显著性差异(P<0.05)。结论:根据中医理论的整体观念而组方制成的伤筋活血合剂,制备工艺可行,临床疗效良好。 OBJECTIVE: To develop a method for the treatment of the fractures of the ankle joint and the fracture of the lower end of the radius. Methods: The quality control method of the mixture was established. The patients in the second group of fractures of the ankle joint and the lower part of the radius were randomly divided into groups and were treated with Zhijin Huoxue Mixture and the corresponding control medicine respectively. The curative effect was observed. RESULTS: The preparation process of Jianjin Huoxue Mixture was simple, reliable, and stable. At the same time, the curative effect of the treatment group was better than that of the control group. In the 4 to 6 weeks, the treatment group and the control group had statistically significant differences (P<0.05). Conclusion: According to the overall concept of traditional Chinese medicine theory, the preparation of wound healing and blood circulation mixture made by the prescription is feasible and the clinical curative effect is good.