Dong Fengyu, Xie Mengdi, Xu Manwen, Lu Lu, Miao Yan, Zhang Panpan, Li Xiaopeng, Gui Xinjing, Liu Ruixin
Henan University of Traditional Chinese Medicine, Zhengzhou, Henan, China.
Department of Pharmacy, First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou, Henan, China.
Biomed Chromatogr. 2023 Dec;37(12):e5745. doi: 10.1002/bmc.5745. Epub 2023 Sep 21.
Dispensing granules of Chinese medicine (DGCM) have emerged as a more convenient alternative to traditional decoction (TD) of Chinese medicine, gaining popularity in recent years. However, the debate surrounding the consistency of DGCM compared to TD remains unresolved. In this study, three batches of Baishao and Gancao DGCM were obtained from manufacturers A, B, and C, and 15 batches of crude drugs were procured from hospital pharmacies for the preparation of dispensing granule decoction (DGD) and TD of Shaoyao-Gancao decoction (SGD). The HPLC-UV method was employed to determine the levels of gallic acid, paeoniflorin, albiflorin, liquiritin, liquiritin apioside, isoliquiritin apioside, isoliquiritin, glycyrrhizic acid, and isoliquiritigenin. The analgesic and antispasmodic effects were assessed using the hot plate and acetic acid writhing test in mice. To evaluate the consistency of chemical constituents and pharmacological effects between the two decoctions, the Criteria Importance Though Intercriteria Correlation (CRITIC) method combined with chemometrics was employed. Grey relation analysis (GRA) was used to assess the comprehensive quality consistency of the two decoctions. The CRITIC results revealed certain differences in chemical constituents and pharmacological effects between the selected DGCM and TD. Notably, DGD-A/C exhibited a significant difference from TD (p > 0.05), whereas DGD-B demonstrated no significant difference from TD (p > 0.05). The GRA analysis demonstrated that the overall quality consistency between DGD-B and TD was the highest among the three manufacturers. This study presents a method for evaluating the quality consistency of DGCM and TD of SGD, offering novel insights into the evaluation of consistency between DGCM and TD.
中药配方颗粒已成为比传统中药汤剂更便捷的替代品，近年来颇受欢迎。然而，与传统汤剂相比，中药配方颗粒的一致性问题仍存在争议。本研究从A、B、C三家生产厂家获取了三批白芍甘草配方颗粒，并从医院药房采购了15批中药材，用于制备芍药甘草汤的配方颗粒汤剂（DGD）和传统汤剂（TD）。采用高效液相色谱-紫外检测法（HPLC-UV）测定没食子酸、芍药苷、 albiflorin、甘草苷、甘草苷芹菜糖苷、异甘草苷芹菜糖苷、异甘草苷、甘草酸和异甘草素的含量。通过热板法和醋酸扭体试验对小鼠进行镇痛和解痉作用评估。为评价两种汤剂化学成分和药理作用的一致性，采用了基于化学计量学的标准重要性通过指标间相关性（CRITIC）方法。采用灰色关联分析（GRA）评价两种汤剂的综合质量一致性。CRITIC结果显示，所选配方颗粒与传统汤剂在化学成分和药理作用上存在一定差异。值得注意的是，DGD-A/C与传统汤剂有显著差异（p＞0.05），而DGD-B与传统汤剂无显著差异（p＞0.05）。GRA分析表明，三家生产厂家中，DGD-B与传统汤剂的整体质量一致性最高。本研究提出了一种评价芍药甘草汤配方颗粒与传统汤剂质量一致性的方法，为评价配方颗粒与传统汤剂的一致性提供了新的见解。
