目的 建立妇康宝口服液（Fukangbao oral liquid，FOL）的HPLC指纹图谱、化学计量学和多指标成分定量测定相结合的质量评价方法。方法 采用菲罗门色谱柱，以乙腈-0.1%磷酸水溶液为流动相，进行梯度洗脱，体积流量1.0 mL/min，柱温35℃，检测波长237 nm，芍药苷对照品为参照，建立了FOL HPLC指纹图谱，结合层次聚类分析（hierarchical cluster analysis，HCA）、主成分分析（principal component analysis，PCA）和偏最小二乘法-判别分析（partial least squares-discriminant analysis，PLS-DA）对5家生产企业共29批FOL进行质量评价，开发并验证了3种指标成分的定量测定分析方法。结果 指纹图谱及定量测定的方法学验证均良好，29批FOL样品指纹图谱相似度均大于0.85，共确定了22个共有峰，并通过与对照品比较指认了其中3个色谱峰，分别为甘草苷、甘草酸和芍药苷。HCA与PLS-DA结果一致，29批FOL样品可按不同生产厂家、不同生产日期聚类，并筛选出引起FOL质量差异的9个差异性成分，分别为色谱峰12、3、4、18、14、9、20、21、22。9个差异性成分主要来自于药味白芍和甘草，建立的芍药苷、甘草苷和甘草酸定量测定方法能够同时快速、准确测定FOL中关键差异性成分含量。结果显示，不同厂家、不同批次FOL样品中芍药苷、甘草苷和甘草酸含量差异明显。结论 建立的FOL HPLC指纹图谱、化学计量学和多指标成分含测方法相结合的FOL质量评价方法，快速、准确、高效、特征性强、重复性和稳定性较好，可用于市售FOL产品的质量评价，也可为各生产企业完善FOL质量控制体系提供参考。

Objective To establish a quality evaluation method for Fukangbao Oral Liquid (FOL, 妇康宝口服液) by combining HPLC fingerprint, multi-index content determination, and analyze the content determination results by chemometrics method.Methods The analysis was carried out on Phenomenex chromatographic column with acetonitrile-0.1% phosphoric acid solution as the mobile phase by gradient elution, flow rate of 1.0 mL/min, column temperature of 35 ℃, detection wavelength of 237 nm, and paeoniflorin reference substance. The determination results were comprehensively analyzed using hierarchical cluster analysis (HCA), principal component analysis (PCA), and partial least squares-discriminant analysis (PCA) to evaluate the quality of 29 batches of FOL from five production enterprises. The content determination and analysis methods of three indicator components were developed and validated.Results The methodological validation of fingerprint spectra and content determination was good, and the similarity of fingerprint spectra of 29 batches of FOL was greater than 0.85. A total of 22 common peaks were identified, and three chromatographic peaks were identified by comparison with the control substance, namely liquiritin, glycyrrhetinic acid and paeoniflorin. The results of HCA and PLS-DA are consistent. 29 batches of FOL samples can be clustered according to different manufacturers and production dates. Nine differential components that cause differences in the quality of FOL can be screened, namely chromatographic peaks 12, 3, 4, 18, 14, 9, 20, 21, 22. The nine differential components mainly come from the medicinal flavors of Baishao (Paeoniae Radix Alba, PRA) and Gancao (Glycyrrhizae Radix et Rhizoma, GRR). The established method for determining the content of paeoniflorin, liquiritin, and glycyrrhetinic acid can simultaneously, quickly, and accurately determine the content of key differential components in FOL. The results showed significant differences in the content of paeoniflorin, liquiritin, and glycyrrhizic acid in FOL from different manufacturers and batches.Conclusion The established HPLC fingerprint, multi-index component content determination method, and chemometric combined quality evaluation method for FOL are fast, accurate, efficient, highly characteristic, have good repeatability and stability. The method can be used for the quality evaluation of commercially available FOL products, and can be used to improve the quality control system of FOL.

R283.6

国家药品监督管理局中国药品监管科学行动计划重点项目（NMPAJGKX-2023-079）<