目的:制备壮腰胶囊并验证其临床疗效。方法:将半处方量药材煎煮,制成清膏,另半处方量药材粉碎成细粉,两者混合制粒装胶囊,并与腰痛宁胶囊对比应用,观察疗效。结果:治疗组总有效率94%,对照组总有效率92．5%,二者疗效无统计学差异。结论:该胶囊制备工艺简单,质量可控,临床应用效果可靠,值得进一步研究。 Objective: To prepare Zhuangyao capsule and verify its clinical efficacy. Methods: The semi-prescription medicinal herbs were decocted to make a clear paste, and the other half of the prescribed amount of medicinal materials was crushed into fine powder. The two were mixed and granulated and loaded into capsules, and were compared with Yaotongning capsules to observe the curative effect. Results: The total effective rate was 94% in the treatment group and 92.5% in the control group. There was no statistical difference in the efficacy between the two groups. Conclusion: The capsule preparation process is simple, the quality is controllable, and the clinical application effect is reliable. It is worth further study.