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3篇 您的检索式:作者名="Zeneng Cheng"
    题名 作者 年代 出处 被引量
1Determination of 20(S)-protopanaxadiol in human plasma by HPLC–MS/MS:application to a pharmacokinetic study显示文摘A rapid,specific and sensitive HPLC-MS/MS method was developed and validated for the determination of 20(S)-protopanaxadiol(PPD)in human plasma.PPD and the internal standard PD were extracted from plasma by liquid-liquid extraction with cyclohexane-methylene dichloride(2:1,v/v).The separation was performed on a HyPURIYTY C18 column using methanol-5 mM ammonium formate(90:10,v/v)as mobile phase at a flow rate of 0.35 mL/min.Mass spectrometric detection was carried out by electrospray ionization(ESI)in the positive ion mode using multiple reaction monitoring(MRM).The monitored transitions were m/z 425.4-217.2 for PPD and at m/z 461.4-425.5 for PD.The method was linear over the range 0.512-100 ng/mL with a lower limit of quantification(LLOQ)of 0.512 ng/mL.The mean extraction recovery of PPD was greater than 78.2%and no significant matrix effect was detected.The intra-and inter-day precisions were less than 10%and the biases below 4%for PPD.The validated method was applied to a three-level single-dose clinical pharmacokinetics study of 12 healthy Chinese volunteers and the main pharmacokinetic parameters of PPD were obtained.Feifan Xie Sanwang Li Zeneng Cheng Xingling Liu Hong Zhang Peijiong Li Zhi Liu Xin Guo Peng Yu 2013Acta Pharmaceutica Sinica B2013,3,6:3
2Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products of agomelatine in Chinese subjects显示文摘The aim of this study was to apply the reference-scaled average bioequivalence(RSABE)approach to evaluate the bioequivalence of 2 formulations of agomelatine,and to investigate the pharmacokinetic properties of agomelatine in Chinese healthy male subjects.This was performed in a single-dose,randomized-sequence,open-label,four-way crossover study with a one-day washout period between doses.Healthy Chinese males were randomly assigned to receive 25 mg of either the test or reference formulation.The formulations were considered bioequivalent if 90% confidence intervals(CIs)for the log-transformed ratios and ratio of geometric means(GMR)of AUC and C_(max) of agomelatine were within the predetermined bioequivalence range based on RSABE method.Results showed that both of the90% CIs for the log-transformed ratios of AUC and C_(max) of 7-desmethyl-agomelatine and 3-hydroxyagomelatine were within the predetermined bioequivalence range.The 90% CIs for natural logtransformed ratios of C_(max) ,AUC_(0–t)and AUC_(0–∞) of agomelatine(104.42–139.86,101.33–123.83 and97.90–117.94)were within the RSABE acceptance limits,and 3-hydroxy-agomelatine(105.55–123.03,101.95–109.10 and 101.72–108.70)and 7-desmethyl-agomelatine(104.50–125.23,102.36–111.50 and101.62–110.64)were within the FDA bioequivalence definition intervals(0.80–1.25 for AUC and0.75–1.33 for C_(max)).The RSABE approach was successful in evaluating the bioequivalence of these two formulations.Fang Tang Rui Zhou Zeneng Cheng Guoping Yang Aiqiao Chen Zhi Liu Hongyi Tan Shuang Yang Sanwang Li Lingli Mu Peng Yu 2016Acta Pharmaceutica Sinica B2016,6,1:2
3Determination of nifeviroc, a novel CCR5 antagonist: Application to a pharmacokinetic study显示文摘Wei Wu Dong Xie Zeneng Cheng Zhi Liu Liling Ran Zhenkun Gu Peng Yu 2011Journal of Pharmaceutical and Biomedical Analysis2011,,3:1
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