College of Pharmaceutical Science, Zhejiang University of Technology, Hangzhou, China.
Zhejiang Provincial Key Laboratory of TCM for Innovative R & D and Digital Intelligent Manufacturing of TCM Great Health Products, Huzhou, China.
Phytochem Anal. 2024 Jun;35(4):873-888. doi: 10.1002/pca.3334. Epub 2024 Feb 17.
Zhou Tian Formula (ZTF) is an antidepressant traditional Chinese medicine utilized widely in clinical settings for the treatment of patients with depression. However, shortcomings persist in its extraction technology and quality control.
This study aimed to propose a methodology for ZTF extraction technology based on the analytic hierarchy process (AHP)-criteria importance through intercriteria correlation (CRITIC) method and to establish a quality control framework for the efficient transfer of index components.
Firstly, we analyzed the chemical components of ZTF and determined the optimal extraction technology. Secondly, we calculated the transfer efficiency of the index components during the conversion of water decoction to extract powder and subsequently to granules. Thirdly, we established HPLC fingerprints for 15 batches of ZTF water decoction, extract powder, and granules. We employed SIMCA software to analyze the chemicals responsible for variations in quality among different batches of ZTF granules.
We determined the optimal extraction process. The average transfer efficiency of ferulic acid, puerarin, mirificin, isoferulic acid, and calycosin during the conversion of water decoction to extract powder and subsequently to granules exceeded 41%. The HPLC fingerprints of ZTF exhibited a similarity exceeding 0.890. Variable importance in projection values indicated that calycosin, ferulic acid, and puerarin were the primary contributors to quality variations.
The AHP-CRITIC method, coupled with an orthogonal array design, could be used for exploring extraction technology. In addition, the rules governing the transfer of index components from water decoction to extract powder, and subsequently to granules, could be applied for the evaluation and quality assessment of ZTF.
周氏复方(ZTF)是一种抗抑郁的中药,在临床上广泛用于治疗抑郁症患者。然而,其提取技术和质量控制仍存在缺陷。
本研究旨在提出一种基于层次分析法(AHP)-通过准则相关性(CRITIC)方法的 ZTF 提取技术方法,并建立一个有效的指标成分传递质量控制框架。
首先,我们分析了 ZTF 的化学成分,确定了最佳提取工艺。其次,我们计算了在水提物转化为提取物粉末和随后转化为颗粒的过程中,指标成分的传递效率。第三,我们建立了 15 批 ZTF 水提物、提取物粉末和颗粒的 HPLC 指纹图谱。我们采用 SIMCA 软件分析了不同批次 ZTF 颗粒质量差异的化学成分。
我们确定了最佳提取工艺。在水提物转化为提取物粉末和随后转化为颗粒的过程中,阿魏酸、葛根素、米利菲林、异阿魏酸和毛蕊异黄酮的平均传递效率超过 41%。ZTF 的 HPLC 指纹图谱相似度超过 0.890。投影变量重要性值表明,毛蕊异黄酮、阿魏酸和葛根素是质量变化的主要贡献者。
AHP-CRITIC 方法与正交数组设计相结合可用于探索提取技术。此外,还可以应用从水提物到提取物粉末,再到颗粒的指标成分传递规律,对 ZTF 进行评价和质量评估。