目的 以芍药甘草汤（Shaoyao Gancao Decoction，SGD）为例，进行均一化投料工艺研究，从均一化饮片、汤剂、中成药三重环节，结合多成分含量、特征图谱、量值传递等数据，完成SGD均一化投料工艺全流程，探讨并确定SGD均一化投料工艺的质量范围，实现批间质量均一稳定。方法 采用UHPLC法对多批次白芍、炙甘草饮片含量进行测定；选取平均值作为饮片标准质量，以此作为均一化标准饮片目标质量；计算各批饮片均一化投料比例，完成投料，制备SGD均一化标准汤剂、中成药；设定质量浓度范围，建立均一化标准汤剂、中成药特征图谱。将饮片分级后，新制备15批均一化汤剂及中成药，验证质量浓度范围的合理性，综合评价均一化工艺。结果 设置均一化标准饮片中芍药苷、甘草苷、甘草酸质量分数分别为2.236%～2.506%、0.500%～0.680%、1.870%～2.215%；均一化标准汤剂中各成分矫正质量浓度分别为芍药苷2.014～2.522 mg/mL、甘草苷0.170～0.282 mg/mL、甘草酸0.489～0.718 mg/mL；均一化标准中成药中各成分矫正质量浓度分别为芍药苷1.950～2.391 mg/mL、甘草苷0.159～0.269 mg/mL、甘草酸0.453～0.673 mg/mL；均一化标准汤剂、中成药特征图谱中共匹配16个特征峰，通过对照品共指认出8个特征峰。新制备的均一化汤剂及中成药中各成分均在设置的质量浓度范围内；将各组特征图谱与均一化标准汤剂、中成药对照特征图谱进行对比，相似度均大于0.995。结论 以饮片标准质量为目标，通过均一化投料得到质量均一的饮片，降低了投料饮片的质量波动，最终得到批间质量均一稳定的SGD汤剂及中成药，为中成药质量一致性工艺研究提供可行性方案。

Objective Taking Shaoyao Gancao Decoction (SGD, 芍药甘草汤) as an example, the homogenization feeding process was studied. From the triple links of homogenization decoction pieces, decoction and Chinese patent medicine, combined with multi-component content, characteristic spectrum, value transfer and other data, the whole process of homogenization feeding process of SGD was completed, and the quality range of homogenization feeding process of SGD was discussed and determined, so as to achieve uniform and stable quality between batches. Methods UHPLC method was used to determine the content of multiple batches of Baishao (Paeoniae Radix Alba) and Zhigancao (Glycyrrhizae Radix Preparata). The average value was selected as the standard quality of decoction pieces, which was used as the target quality of normalized standard decoction pieces. Calculate the proportion of homogenization of each batch of decoction pieces, complete the feeding, and prepare the SGD homogenization standard decoction and Chinese patent medicine; the mass concentration range was set, and the characteristic chromatograms of normalized standard decoction and Chinese patent medicine were established. After the decoction pieces were graded, 15 batches of homogenized decoctions and Chinese patent medicines were newly prepared to verify the rationality of the mass concentration range and comprehensively evaluate the homogenization process. Results The mass fractions of paeoniflorin, liquiritin and glycyrrhizic acid in normalized standard decoction pieces were 2.236%—2.506%, 0.500%—0.680% and 1.870%—2.215%, respectively. The corrected mass concentrations of each component in the normalized standard decoction were 2.014—2.522 mg/mL for paeoniflorin, 0.170—0.282 mg/mL for liquiritin, and 0.489—0.718 mg/mL for glycyrrhizic acid, respectively. The corrected mass concentrations of each component in the standard Chinese patent medicine were 1.950—2.391 mg/mL for paeoniflorin, 0.159—0.269 mg/mL for liquiritin, and 0.453—0.673 mg/mL for glycyrrhizic acid, respectively. A total of 16 characteristic peaks were matched in the characteristic chromatograms of homogenized standard decoctions and Chinese patent medicines, and eight characteristic peaks were identified by reference substances. The components in the newly prepared homogenized decoction and Chinese patent medicine were within the set mass concentration range. The characteristic chromatograms of each group were compared with the characteristic chromatograms of homogenized standard decoction and Chinese patent medicine, and the similarity was greater than 0.995. Conclusion Taking the standard quality of decoction pieces as the goal, the decoction pieces with uniform quality are obtained by homogenizing the feeding, which reduces the quality fluctuation of the feeding decoction pieces, and finally obtains the SGD and Chinese patent medicine with uniform and stable quality between batches, which provides a feasible scheme for the study of the quality consistency process of Chinese patent medicine.

R283.6

国家科技重大专项“重大新药创制”（2018ZX09721005）;中国中医科学院科技创新工程项目（CI2021A04506）;中国中医科学院科技创新工程项目（CI2023E001TS）;2023年全国中药特色技术传承人才培训项目（ZXKT23025）