title: Population pharmacokinetics of naringin in total flavonoids of Drynaria fortunei (Kunze) J. Sm. in Chinese women with primary osteoporosis.
abstract: OBJECTIVE
  To evaluate the effect of covariates on the pharmacokinetic profiles of naringin in the total flavonoids of Drynaria fortunei (Kunze) J. Sm. in the Qianggu Capsule () by evaluating Chinese women with primary osteoporosis.
  
  
  METHODS
  A total of 98 female patients from the communities of Jingshan, Beixinqiao, Jiaodaokou, Chaoyangmen, and Donghuamen in Beijing, China, aged 40 to 80 years, were included in this study. Blood samples were collected before and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h after a single oral dose of Qianggu Capsule. The concentration in blood samples from 32 patients before and 0.5, 1, 2, 3, and 4 h after drug administration were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, and full set of pharmacokinetic data was analyzed with nonlinear mixed-effect modeling (NONMEM) software. The mean of population parameters clearance (C1), central distribution volume (V), absorption rate constant (Ka1), inter-compartmental clearance (C2), peripheral distribution volume (V2) were set as parameters and estimated through base model, covariate model, and final model. Age, height, weight, blood urea nitrogen (BUN), serum creatinine (Scr), alanine transaminase (ALT), aspartate transaminase (AST), hyperlipidemia, Liver (Gan) Kidney (Shen) yin insufficiency (GSYI), Kidney (Shen) yang insufficiency (SYI) were set as covariates.
  
  
  RESULTS
  The relationships between these parameters and covariates were analyzed. The results showed that C1 was the main parameter influenced by the selected covariates among the population parameters, and the relationships between the covariates and C1 were analyzed, among the selected covariates hyperlipidemia was identified as significant covariate of C1.
  
  
  CONCLUSIONS
  The pharmacokinetic behaviors of naringin are altered with hyperlipidemia in Chinese women with primary osteoporosis.
authors.affiliation: Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100093, China.
authors.forename: Jian-nong
authors.initials: JN
authors.lastname: Wang
authors.forename: Jun-jie
authors.initials: JJ
authors.lastname: Jiang
authors.forename: Yan-ming
authors.initials: YM
authors.lastname: Xie
authors.forename: Xu
authors.initials: X
authors.lastname: Wei
authors.forename: Jian-peng
authors.initials: JP
authors.lastname: Li
authors.forename: Jing-li
authors.initials: JL
authors.lastname: Duan
authors.forename: Xin
authors.initials: X
authors.lastname: Xiong
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002681:China; D002851:Chromatography, High Pressure Liquid; D005260:Female; D044950:Flavanones / Q000032:analysis / Q000493:pharmacokinetics*; D005419:Flavonoids / Q000737:chemistry*; D006801:Humans; D008875:Middle Aged; D010024:Osteoporosis / Q000378:metabolism*; D029621:Polypodiaceae / Q000737:chemistry*; D053719:Tandem Mass Spectrometry
chemical_list: D044950:Flavanones; D005419:Flavonoids; C005274:naringin