Zhou Yongfeng, Wu Qinghua, Ren Chaoxiang, Jiang Huajuan, Huang Xulong, Chen Jiang, Zhang Ping, Zhang Dingkun, Pei Jin
Department of Pharmacy, The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, China.
State Key Laboratory of Southwestern Chinese Medicine Resources, College of Pharmacy, Chengdu University of Traditional Chinese Medicine, Chengdu, China.
Front Pharmacol. 2025 Apr 15;16:1554895. doi: 10.3389/fphar.2025.1554895. eCollection 2025.
The quality of traditional Chinese medicine (TCM) guarantees clinical efficacy. At present, although chemical quality evaluation methods can reflect the quality of TCMs to a certain extent, there are still many problems. This study proposes a new strategy for the quality innovation evaluation of the TCM "target combined quality evaluation" (TCQE) theory and method. Taking the "disease-target-medicine" combination as the main fusion strategy, using drug components/ components to achieve the overall intervention of disease targets, and establishing the TCQE strategy of TCM to improve the pertinence and accuracy of the quality evaluation of TCM, the clinical efficacy and safety of TCM is improved, and precision clinical medication is achieved.
Taking safflower as the research object, due to its main efficacy in the treatment of primary dysmenorrhea (PD), the potential targets and mechanism of action of safflower in the treatment of PD were analyzed by a network pharmacology method and combined with a metabolomics method. The pathway and mechanism of action of safflower in the treatment of PD were analyzed from multiple dimensions. The network pharmacology and metabolomics results were analyzed, the key targets of safflower in the treatment of PD were screened. Finally, a method for the biological evaluation of safflower quality was established based on the selected targets, which could provide a reference for the precise evaluation of safflower treatment and a scientific basis for the clinical application of safflower in the prevention and treatment of PD.
The pharmacodynamic results showed that Safflower significantly improved Prostaglandin E2 (PGE2) and Prostaglandin F2 α (PGF2 α) levels, the PGF2 α/PGE2 ratio and the analgesic rate in PD rats. The results of network pharmacology combined with metabolomics analysis showed that Prostaglandin G/H synthase 2 (PTGS2) and arachidonic acid (AA)were important targets and pathways of Safflower in the treatment of PD. A biological evaluation method was established around PTGS2. The results of the methodological investigation showed that the method was stable and reliable. In vivo validation experiments showed that the results of this method were consistent with the pharmacodynamic results, which proved its accuracy. PTGS2 is an important target of safflower in the treatment of PD. The biological evaluation method established around PTGS2 can accurately evaluate the quality of Safflower in the treatment of PD, which also proves that the target discrimination theory proposed in this study is scientific.
中药质量保障临床疗效。目前，化学质量评价方法虽能在一定程度上反映中药质量，但仍存在诸多问题。本研究提出一种中药质量创新评价的新策略——“靶点结合质量评价”（TCQE）理论与方法。以“疾病-靶点-药物”组合为主要融合策略，利用药物成分/组分实现对疾病靶点的整体干预，建立中药TCQE策略，以提高中药质量评价的针对性和准确性，提升中药临床疗效与安全性，实现精准临床用药。
以红花为研究对象，因其主要功效为治疗原发性痛经（PD），采用网络药理学方法并结合代谢组学方法分析红花治疗PD的潜在靶点及作用机制。从多个维度分析红花治疗PD的作用途径和机制。对网络药理学和代谢组学结果进行分析，筛选出红花治疗PD的关键靶点。最后，基于所选靶点建立红花质量的生物学评价方法，可为红花治疗的精准评价提供参考，为红花在PD防治中的临床应用提供科学依据。
药效学结果表明，红花显著改善PD大鼠前列腺素E2（PGE2）、前列腺素F2α（PGF2α）水平、PGF2α/PGE2比值及镇痛率。网络药理学与代谢组学分析结果表明，前列腺素G/H合酶2（PTGS2）和花生四烯酸（AA）是红花治疗PD的重要靶点和途径。围绕PTGS2建立了生物学评价方法。方法学考察结果表明该方法稳定可靠。体内验证实验表明该方法结果与药效学结果一致，证明了其准确性。PTGS2是红花治疗PD的重要靶点。围绕PTGS2建立的生物学评价方法可准确评价红花治疗PD的质量，也证明了本研究提出的靶点判别理论具有科学性。
