目的 建立三颗针标准汤剂质量评价体系。方法 根据标准汤剂的制备要求，制备15批三颗针标准汤剂冻干粉，以薄层色谱法鉴别三颗针标准汤剂中的指标成分，采用HPLC法对指标成分进行含量测定，并计算指标成分转移率和出膏率；采用红外光谱仪分别扫描15批三颗针标准汤剂，建立红外指纹图谱，采用双指标序列分析法分析各批次间相关性；采用紫外可见分光光度计分别扫描15批三颗针标准汤剂，建立紫外对照图谱，利用SPSS软件分析样品指纹图谱与对照指纹图谱的相似度。结果 15批标准汤剂的出膏率为3.42%～6.36%，盐酸小檗碱质量分数为7.53%～13.98%，总转移率为39.64%～73.62%；三颗针标准汤剂与盐酸小檗碱对照品、三颗针对照药材溶液在同一硅胶G薄层板相同位置显相同颜色的荧光斑点；红外指纹图谱共有峰率下限为50.0%，变异峰率为0～62.5%；紫外指纹图谱相似度均大于0.9，变异可接受范围为0.768～1.000。结论 建立了稳定、可靠的三颗针标准汤剂全面质量评价方法，为三颗针配方颗粒的质量控制提供参考。

Objective To establish the quality evaluation system of Berberidis Radix (BR) standard decoction. Methods According to the preparation requirements of BR standard decoction, 15 batches of BR standard decoction powder was prepared, and, the index components in BR standard decoction was identified by using TLC chromatography. The content of index components was then detected by using HPLC, and the transfer rate of the index composition and the yield of the paste were calculated. Using infrared spectrometer to scan 15 batches of three standard decoctions. The infrared fingerprint spectrum was established, and the correlation between each batch was analyzed by using the two-index sequence analysis method. UV-vis spectrophotometer was used to respectively scan 15 batches of three needle standard medicinal broth for, establishing ultraviolet control map. The similarity between the fingerprint of sample and control was analyzed by SPSS software. Results The yield of 15 batches of standard decoction was 3.42%-6.36%. The content of berberine hydrochloride was 7.53%-13.98%, and the total transfer rate was 39.64%-73.62%. The same colored fluorescent spots were appeared at the corresponding positions of BR standard decoction, the berberine hydrochloride control, and BR control solution and the spots were in the same position of the same silica gel G thin layer. The lower limit of total peak rate of IR fingerprint was 50.0%, and the variation peak rate was 0.0%-62.5%. The similarity of UV fingerprints was all greater than 0.9, and the variation acceptable range was 0.768-1.000. Conclusion A stable and reliable method for the comprehensive quality evaluation of BR standard decoction was established, which can provide reference for the quality control of BR formula granules.

四川省千人计划项目（2013332）；四川省科技厅2018年科技项目（2018TJPT0049，2018ZR0107）；成都大学教改项目（cdjgy2017010）