基于效应成分当量的黄连饮片调剂一致性研究

Uniformity of Coptidis Rhizoma decoction pieces dispensing based on effective constituent equivalence

中药调剂是中药面向临床的最后一关,中药调剂的稳定性保证是中药临床疗效的关键。以临床功用为导向,建立基于效应成分当量的中药饮片质量评控,不仅能保证中药调剂的稳定性,更能关联药效的精准性。该研究选取黄连为模式药,结合课题组前期构建的黄连效应成分指数,建立关联药效的黄连效应成分当量,并根据不同规格黄连饮片的临床量取均一性和煎煮顺应性,研究不同规格黄连饮片的调剂一致性,用于指导黄连饮片规格优选和临床调剂。结果表明,效应成分当量能直观的表征规格、量取和煎煮波动对中药药效的影响;依据效应成分当量所筛选的黄连饮片,具有临床调剂均一性高,煎煮顺应性好,效应成分当量高的特点。效应成分当量能提高中药调剂一致性评控的临床关联性;依据效应成分当量研制的"精标饮片"具有质量好、剂量调节性强等优点,该饮片的研制能促进中药饮片向精准稳定的方向迈进。

Traditional Chinese medicine（ TCM） dispensing is the final step of TCM used for clinical treatment,the stability of TCM dispensing is the guarantee of good clinical effect. Establishment of effect-constituent equivalence for Chinese herbal pieces based on clinical efficacy,can not only guarantee the stability of TCM dispensing,but also relate to the precision of clinical effect. This study chose Coptidis Rhizoma as the model,established effect-constituent equivalence of Coptidis Rhizoma,based on the effect-constituent index already established by our research group,and taking into consideration of homogeneity of clinical dosage and compliance of decoction,the uniformity of dispensing for different specification of Coptidis Rhizoma decoction pieces was studied. This research model was then applied to guide the specification-optimization of Coptidis Rhizoma and its clinical dispensing. The result indicated,effective constituent equivalence could reflect the fluctuation of specification,dosage and decoction to the fluctuation of efficacy; Optimized Coptidis Rhizoma decoction pieces had the characteristic of high homogeneity as for clinical dispensing,good compliance as for decoction,and high effective constituent equivalence. In conclusion,effective constituent equivalence could improve relevance of methods of TCM dispensing control to clinical effect. Preparated Superior-standard Decoction Pieces based on effective constituent equivalence was featured by good quality and a good practice of adjustable dosage,which could promote the development of TCM decoction pieces toward precision medicine.