College of Pharmacy, Nanjing University of Chinese Medicine, Nanjing 210046, China.
College of Pharmacy, Nanjing University of Chinese Medicine, Nanjing 210046, China.
Fitoterapia. 2024 Oct;178:106169. doi: 10.1016/j.fitote.2024.106169. Epub 2024 Aug 3.
Curcumae rhizoma (CR) is the dried rhizoma of Curcuma phaeocaulis Val (CP), Curcuma kwangsiensis S. G. Lee et C. F. Liang (CK) and Curcuma wenyujin Y. H. Chen et C. Ling (CW), used widely to treat blood stagnation in China. Currently, quality control indicators for CR are limited to chemical composition analysis. It is unclear whether the current quality standard of the multicomponent content of CR can reflect clinical effects, due to the lack of the evaluation of biological effects. A method of evaluating quality was developed called the effect-constituent index (ECI). By meticulously measuring and calibrating the key active components, the ECI offers a comprehensive assessment of the CR's biological effects, establishing a crucial link to clinical efficacy and safety. An analytical protocol employing high-performance liquid chromatography (HPLC) was devised to ascertain the presence and measure ten principal constituents within CR sourced from various species and the content of total volatile oil was also measured. An In vitro antiplatelet aggregation assay was developed to measure the antiplatelet aggregation biopotencies of thirty batches of CR and ten main components. Then, the calibration weights for each constituent in the ECI were determined based on the antiplatelet aggregation biopotency values of eight components with notable efficacy. The ECI calculation involved summing the products obtained by multiplying the content (Ci) of each component by its corresponding biopotency weight (Wi). Correlation analysis unveiled a the most robust correlation (R = 0.8579, p < 0.001) between ECI and antiplatelet aggregation biopotency of CR, when compared to individual components or volatile oil content. The devised ECI, synthesizing chemical and biological data pertinent to clinical effectiveness, facilitates a nuanced assessment of CR quality across various species in its efficacy in treating blood stagnation. This method addresses the challenge of guaranteeing effectiveness through chemical analysis alone. This study offers substantiation for the applicability of the ECI as a tool for assessing the quality of traditional Chinese medicine (TCM).
莪术为姜科植物蓬莪术 Curcuma phaeocaulis Val.、广西莪术 Curcuma kwangsiensis S. G. Lee et C. F. Liang 或温郁金 Curcuma wenyujin Y. H. Chen et C. Ling 的干燥根茎,在中国被广泛用于治疗血瘀证。目前,莪术的质量控制指标仅限于化学成分分析。由于缺乏对生物效应的评价,尚不清楚莪术的多成分含量的现行质量标准是否能反映临床疗效。一种被称为效应成分指数(ECI)的质量评价方法已经被开发出来。通过精心测量和校准关键活性成分,ECI 提供了莪术生物效应的全面评估,建立了与临床疗效和安全性的重要联系。设计了一种采用高效液相色谱法(HPLC)的分析方案,以确定来自不同种属的莪术中十种主要成分的存在和含量,并测量总挥发油的含量。建立了体外抗血小板聚集试验,以测量 30 批莪术和 10 种主要成分的抗血小板聚集生物效价。然后,根据 8 种具有显著疗效的成分的抗血小板聚集生物效价值,确定 ECI 中每个成分的校准权重。ECI 的计算涉及将每个成分的含量(Ci)与其相应的生物效价权重(Wi)相乘所得到的乘积求和。相关性分析显示,与单个成分或挥发油含量相比,ECI 与莪术抗血小板聚集生物效价之间具有最强的相关性(R=0.8579,p<0.001)。该方法综合了与临床疗效相关的化学和生物学数据,对不同种属莪术治疗血瘀证的疗效进行了细致的评价。这种方法解决了仅通过化学分析保证有效性的挑战。本研究为 ECI 作为评估中药质量的工具的适用性提供了依据。