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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。
Chinese medicine is the traditional Chinese medicine clinics for the final step, the stability of Chinese medicine transfers is the key to the clinical efficacy of traditional Chinese medicine. To guide the clinical function, the establishment of quality control based on the equivalent composition of Chinese medicine Pieces, not only to ensure the stability of Chinese medicine transfer, but also more accurate correlation of efficacy. In this study, Coptis chinensis was selected as the model drug. Based on the Coptis chinensis effect component index previously established by the research group, the pharmacological effects of Coptis chinensis copulate were established. According to the clinical measures of homogeneity and boiling compliance of Coptis chinensis Pieces, Coptis tablets consistency of the regulation, used to guide the specification of the best Coptis and clinical adjustment. The results showed that the equivalent of the effective component could directly characterize the influence of the specifications, the amount of extraction and the volatility of decoction on the efficacy of traditional Chinese medicine. The Coptis chinensis Pieces screened according to the equivalent amount of the active ingredient had the advantages of high uniformity of clinical preparation, good boiling compliance, High equivalent characteristics. The effective component equivalent can improve the clinical relevance of the consistency control of traditional Chinese medicine (TCM) formulation. Based on the equivalence of the effective components, the quality of the “refined standard” has the advantages of good quality and strong dose regulation. Steady direction.