中国健康人群西布曲明的群体药动学模型的建立

陈晓晶; 李中东; 丁俊杰; 施孝金; 徐一新

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中国健康人群西布曲明的群体药动学模型的建立

陈晓晶, 李中东, 丁俊杰, 施孝金, 徐一新

文章导航 > 药学实践与服务 > 2012 > 30(4): 283-286

陈晓晶, 李中东, 丁俊杰, 施孝金, 徐一新. 中国健康人群西布曲明的群体药动学模型的建立[J]. 药学实践与服务, 2012, 30(4): 283-286.

引用本文:

陈晓晶, 李中东, 丁俊杰, 施孝金, 徐一新. 中国健康人群西布曲明的群体药动学模型的建立[J]. 药学实践与服务, 2012, 30(4): 283-286.

CHEN Xiao-jin, LI Zhong-dong, DING Jun-jie, SHI Xiao-jin, XU Yi-xin. Establishment of the population pharmacokinetics model of sibutramine in Chinese healthy volunteers[J]. Journal of Pharmaceutical Practice and Service, 2012, 30(4): 283-286.

Citation:

CHEN Xiao-jin, LI Zhong-dong, DING Jun-jie, SHI Xiao-jin, XU Yi-xin. Establishment of the population pharmacokinetics model of sibutramine in Chinese healthy volunteers[J]. Journal of Pharmaceutical Practice and Service, 2012, 30(4): 283-286.

中国健康人群西布曲明的群体药动学模型的建立

1.
上海健康职业技术学院药学教研室, 上海200237
2.
复旦大学附属华山医院药剂科, 上海200040
3.
复旦大学附属儿科医院, 上海201102

Establishment of the population pharmacokinetics model of sibutramine in Chinese healthy volunteers

1.
Pharmacy Department, Shanghai Healthy Vocational & Technical College, Shanghai 200237, China
2.
Pharmacy Department, Huashan Hospital, Fudan University, Shanghai 200040, China
3.
Children′s Hospital, Fudan University, Shanghai 201102, China

摘要: 目的建立中国人群中西布曲明的群体药动学模型.方法 20例男性健康志愿者口服10 mg西布曲明,于服药后0～24 h采集13个采样点采血,采用已验证的HPLC法测定血药浓度.采用非线性混合效应模型(NONMEM)进行群体药动学分析,估算药动学参数.以直观预测检验(Visual predictive check,VPC)和正态预测分布误差(Normalized predictive distribution error,NPDE),Bootstrap法进行模型性能评估.结果以有吸收时滞的一级吸收和消除的二
- 西布曲明 /
- 群体药动学 /
- 非线性混合效应模型
Abstract: objective To develop the population pharmacokinetics model of sibutramine (SIB) in Chinese healthy volunteers.Methods Twenty male healthy volunteers were enrolled into the study.13 blood sampling were drawn after administration of 10 mg SIB within 24h.Theplasma samplesfor SIB concentration were analyzed using validated HPLC/MS method.The population pharmacokinetics was characterized by non-linear mixed effects model (NONMEM).Visual predictive check (VPC) and normalized predictive distribution error (NPDE) were used to evaluate the predictive ability of the model.The reliability and stability of the population pharmacokinetic model developed was further assessed by a nonparametric bootstrap procedure,Results A two-compartment pharmacokinetic model with first-order absorption and elimination was used to describe the concentration-time data.The weight and age had no significant impact on the model parameters.The population typical values (inter-individual variability) of Vl,V2,CL,Q,Ka and Tlag were 7.85 (42.8%) L,2.03 (48.2%)L,1.08 (38.5%)L/h,0.289 (27.1%)L/h,1.95 (56.8%)h～and 0.187 (17.8%)h respectively.Most of parameter estimates from non-parametric bootstrap procedure were comparable and within 10% of the estimates from NONMEM.The stability and the predictive performance were accepted by Bootstrapping,the goodness-of-fit,VPC and NPDE.Conclusion The final population pharmacokinetics model of SIB in Chinese healthy was established by NONMEM,The modcl was steady and reliable.
- sibutramine /
- population pharmacokinetics /
- nonlinear mixed effects model

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中国健康人群西布曲明的群体药动学模型的建立

1. 上海健康职业技术学院药学教研室, 上海200237

2. 复旦大学附属华山医院药剂科, 上海200040

3. 复旦大学附属儿科医院, 上海201102

收稿日期: 2011-10-17
修回日期: 2012-05-23

关键词:

西布曲明 /

群体药动学 /

非线性混合效应模型

摘要: 目的建立中国人群中西布曲明的群体药动学模型.方法 20例男性健康志愿者口服10 mg西布曲明,于服药后0～24 h采集13个采样点采血,采用已验证的HPLC法测定血药浓度.采用非线性混合效应模型(NONMEM)进行群体药动学分析,估算药动学参数.以直观预测检验(Visual predictive check,VPC)和正态预测分布误差(Normalized predictive distribution error,NPDE),Bootstrap法进行模型性能评估.结果以有吸收时滞的一级吸收和消除的二

English Abstract

Establishment of the population pharmacokinetics model of sibutramine in Chinese healthy volunteers

1. Pharmacy Department, Shanghai Healthy Vocational & Technical College, Shanghai 200237, China

2. Pharmacy Department, Huashan Hospital, Fudan University, Shanghai 200040, China

3. Children′s Hospital, Fudan University, Shanghai 201102, China

Received Date: 2011-10-17
Rev Recd Date: 2012-05-23

Keywords:

Abstract: objective To develop the population pharmacokinetics model of sibutramine (SIB) in Chinese healthy volunteers.Methods Twenty male healthy volunteers were enrolled into the study.13 blood sampling were drawn after administration of 10 mg SIB within 24h.Theplasma samplesfor SIB concentration were analyzed using validated HPLC/MS method.The population pharmacokinetics was characterized by non-linear mixed effects model (NONMEM).Visual predictive check (VPC) and normalized predictive distribution error (NPDE) were used to evaluate the predictive ability of the model.The reliability and stability of the population pharmacokinetic model developed was further assessed by a nonparametric bootstrap procedure,Results A two-compartment pharmacokinetic model with first-order absorption and elimination was used to describe the concentration-time data.The weight and age had no significant impact on the model parameters.The population typical values (inter-individual variability) of Vl,V2,CL,Q,Ka and Tlag were 7.85 (42.8%) L,2.03 (48.2%)L,1.08 (38.5%)L/h,0.289 (27.1%)L/h,1.95 (56.8%)h～and 0.187 (17.8%)h respectively.Most of parameter estimates from non-parametric bootstrap procedure were comparable and within 10% of the estimates from NONMEM.The stability and the predictive performance were accepted by Bootstrapping,the goodness-of-fit,VPC and NPDE.Conclusion The final population pharmacokinetics model of SIB in Chinese healthy was established by NONMEM,The modcl was steady and reliable.

陈晓晶, 李中东, 丁俊杰, 施孝金, 徐一新. 中国健康人群西布曲明的群体药动学模型的建立[J]. 药学实践与服务, 2012, 30(4): 283-286.

引用本文:

陈晓晶, 李中东, 丁俊杰, 施孝金, 徐一新. 中国健康人群西布曲明的群体药动学模型的建立[J]. 药学实践与服务, 2012, 30(4): 283-286.

Citation:

CHEN Xiao-jin, LI Zhong-dong, DING Jun-jie, SHI Xiao-jin, XU Yi-xin. Establishment of the population pharmacokinetics model of sibutramine in Chinese healthy volunteers[J]. Journal of Pharmaceutical Practice and Service, 2012, 30(4): 283-286.

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中国健康人群西布曲明的群体药动学模型的建立

Establishment of the population pharmacokinetics model of sibutramine in Chinese healthy volunteers

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中国健康人群西布曲明的群体药动学模型的建立

1. 上海健康职业技术学院药学教研室, 上海200237 2. 复旦大学附属华山医院药剂科, 上海200040 3. 复旦大学附属儿科医院, 上海201102

English Abstract

Establishment of the population pharmacokinetics model of sibutramine in Chinese healthy volunteers

1. Pharmacy Department, Shanghai Healthy Vocational & Technical College, Shanghai 200237, China 2. Pharmacy Department, Huashan Hospital, Fudan University, Shanghai 200040, China 3. Children′s Hospital, Fudan University, Shanghai 201102, China

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目录

1. 上海健康职业技术学院药学教研室, 上海200237

2. 复旦大学附属华山医院药剂科, 上海200040

3. 复旦大学附属儿科医院, 上海201102

1. Pharmacy Department, Shanghai Healthy Vocational & Technical College, Shanghai 200237, China

2. Pharmacy Department, Huashan Hospital, Fudan University, Shanghai 200040, China

3. Children′s Hospital, Fudan University, Shanghai 201102, China