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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2012, Vol. 17 ›› Issue (9): 1010-1014.

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The quantitative evaluation of the Zexie Tiaozhi granule formulation through multiple regression model

HUANG Ji-han1, YIN Fang1, LI Yun-fei1, HE Ying-chun1, ZHANG Mi1, LIU Cheng-hai2, LIU Hong-xia1   

  1. 1Center of Drug Clinical Research, Shanghai University of Chinese Medicine, Shanghai 201203, China;
    2Institute of Liver Diseases, Shuguang Hospital Affiliated to Shanghai University of Chinese Medicine, Shanghai 201203, China
  • Received:2012-02-17 Revised:2012-04-30 Published:2012-09-25

Abstract: AIM: The nonlinear mixed effect model (NONMEM) was applied in the analysis of Traditional Chinese Medicine (TCM) formula, based on the data of different compatibility of Zexie Tiaozhi granule in treatment of hyperlipidemia rat model. The compatible regularity of Zexie Tiaozhi granule was evaluated quantitatively and the result can be used as a reference to formula optimization. METHODS: The four main compositions of Zexie Tiaozhi granule were combined in uniform design and analyzed by NONMEM. The TG in serum was treated as the pharmacodynamics index.RESULTS: Final model suggested that X1 was the primary effective composition and X3 was an antagonistic composition. The dose-effect relationship of X2 and X4 was not clear, and the efficacy was mainly expressed in the interaction between compositions. Based on the above, we recommended that the formula will perform maximum efficacy when X1, X2 and X4 take the maximum dose and X3 take the minimum dose. CONCLUSION: The application of NONMEM in analysis of TCM formula can investigate the interactions among compositions and the random effects like inter individual and intra individual variations comprehensively, which can provide vast quantities of information.

Key words: Multiple regression, Nonlinear mixed effect model, Formula optimization, Simulation

CLC Number: