Abstract

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).

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