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目的:制备复方仙断跌打搽剂并建立其质量控制方法,观察该制剂对各种跌打损伤的临床疗效。方法:采用薄层色谱法对制剂中冰片、薄荷脑、大黄等药材进行定性鉴别;将346例各种跌打损伤患者随机分为治疗组和对照组。治疗组以复方仙断跌打搽剂外用,对照组以正骨水外用,两组进行治疗观察。结果:质控方法可靠,复方仙断跌打搽剂临床疗效好,总有效率达97.74%,明显优于对照组。结论:该制剂制备工艺合理,质量控制方法可靠,临床疗效显著,应用前景良好。
OBJECTIVE: To prepare compound Xianduan or smashing tincture and establish its quality control method, and observe the clinical efficacy of this preparation on various bruises. METHODS: Thin-layer chromatography was used to qualitatively identify borneol, menthol and rhubarb. 346 patients with various bruises were randomly divided into treatment group and control group. The treatment group was treated with Compound Xianduan Xieban tincture for external use, and the control group was treated with Zhenggu water for external use. The two groups were observed for treatment. Results: The quality control method was reliable. The compound Xiandang Xieban had good clinical curative effect and the total effective rate was 97.74%, which was obviously better than the control group. Conclusion: The preparation process is reasonable, the quality control method is reliable, the clinical curative effect is remarkable, and the application prospect is good.