目的:优选祛痹止痛凝胶剂的提取和制备工艺,并建立质量控制方法。方法:采用L_9(3~4)正交设计试验方法,以徐长卿中丹皮酚含量为评价指标,考察最优提取工艺;应用薄层色谱法(TLC)对祛痹止痛凝胶剂中的威灵仙、姜黄及羌活进行定性鉴别;应用高效液相色谱法对祛痹止痛凝胶剂中的丹皮酚进行含量测定。结果:最佳提取工艺为药材加6倍量75%乙醇冷浸48 h;在TLC色谱中可检出威灵仙、姜黄、羌活,与其他组分分离良好;高效液相色谱中丹皮酚在1～32 mg·L~(-1)范围呈良好的线性关系(r=0.999 7),平均回收率为99.22%,RSD为1.45%(n=6)。结论:祛痹止痛凝胶剂的制备工艺简单,质量可靠。 OBJECTIVE: To optimize the extraction and preparation process of Quxu pain gel and establish the quality control method. Methods: L_9 (3 ~ 4) orthogonal design test method was used to evaluate the optimal extraction process of paeonol in Xuchangqing. The TLC Ling Xian, turmeric and notopterygii qualitative identification; application of high performance liquid chromatography Quban pain gel paeonol content determination. Results: The best extraction process was cold-dipping for 48 h with 6 times the amount of 75% ethanol and 6 hours 75% ethanol. Clematis, turmeric and notopterygium could be detected by TLC. The separation of paeonol, In the range of 1 ~ 32 mg · L ~ (-1), there was a good linear relationship (r = 0.999 7) with an average recovery of 99.22% and a RSD of 1.45% (n = 6). Conclusion: Qubi pain gel preparation process is simple, reliable quality.