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Spermatogenic effect of Yacon tubers extracts and its constituents

Spermatogenic effect of Yacon tubers extracts and its consti...

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中国药理学会临床药理学专业委员会会议暨第十次全国临床药理学学术会议

作者： PARK Jeong-sook YANG Jae-sik HWANG Bang-yeon College of Pharmacy CBITRC Chungbuk National UniversityCheongjuHeungdukgu Gaeshindong San 12Chungbuk 361-763S.Korea

AIM:Smallanthus sonchifolius(Yacon)has been used as a food and folk medicine in the Andes *** was screened the pharmacological effects of a 50% ethanol ex- tract of Yacon on spermatogenesis in *** study is carded out to evaluate the possibility of using Yacon tubers extracts as a fertility agent to treat infertility caused by spermatogenic disorders. METHODS:The dried,pulverized Yacon tubers were extracted with 50% ethanol at 50℃ for 5 h under sonica- *** Yacon extracts were analyzed by using HPLC system on a Kromasil ClS column(250mm×4.6 mm). The Yacon tubers extracts,chlorogenic acid and ferulic acid were administrated to rats once daily by oral gavage. The number of sperm heads in the testis was assessed by counting the number of sperm heads using slight modifica- tion of the procedure reported by Toth et al(1989). RESULTS:After administration of chlorogenic acid and Yacon tuber extracts to rat for 5 weeks,the number of sperm in epididymis were increased by 20.33% and 34.48%,*** femlic acid which was report- ed as a metabolite of chlorogenic acid and constituent of Yacon to estimate the spermatogenic activity was also ad- *** administration of ferulic acid and Yacon tubers extracts,the sperm number were increased by 37.87% and 43.33%,*** ef- fects of chlorogenic acid and ferulic acid were 0.59 times and 0.87 times of Yacon tubers extracts,respectively. CONCLUSION:The spermatogenic effect of Yacon tu- bers extracts may result from the combined effect of chloro- genic acid or its analogues and their metabolites.

关键词： Smallanthus sonchifolius spermatogenesis chlomgenic acid ferulic acid fertility

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Ethnic factors in the acceptability of foreign clinical data:The role of ICH E5 guidance in international drug development

Ethnic factors in the acceptability of foreign clinical data...

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中国药理学会临床药理学专业委员会会议暨第十次全国临床药理学学术会议

作者： Niranjan Rao Clinical Pharmacology at Kyowa Pharmaceuticals Inc PrincetonNJ 08540USA

The discovery and development of new drugs is an expensive and lengthy process that can cost several hundr- ed million dollars and over a decade of *** need to repeat large-scale clinical trials in new regions for a drug already deemed safe and efficient for human use in a specific ICH region adds to the cost and delays avail- ability of potentially useful medications in the new region. A case can also be made that this represents unnecessary human experimentation in some *** adoption of the ICH E5 guidance by Japan,US,EU has led to more streamlined development and made important new drugs available more quickly in new *** to this is the concept of a bridging study.A bridging study,while it can have multiple objectives and can take one of several designs,allows one to extrapolate to a new region,safety and efficacy data obtained in a foreign *** pharmacology principles play a key role in the E5 process and help determine the nature and extent of the bridging ***,a medicinal agent is characterized as less or more sensitive to ethnic factors based on PK/PD character- *** include pharmacokinetic linearity or lack thereof,fiat or steep dose/effect response curve,single or multiple pathways of metabolism,low potential for drug- drug and drug food interactions,and high or low bioavail- *** addition to PK/PD principles,several other as- pects need to be *** include medical prac- tice and conduct of clinical trials in different *** a medicinal agent is ethnically insensitive based on PK/PD characteristics,and medical practice and clinical conduct are similar between two regions,a bridging study may not be *** the other hand,a drug which is character- ized as more sensitive to ethnic factors is likely to need more extensive bridging studies,or if necessary,confirma- tory clinical ***,the ICH E5 guidance provides a rational scientific framework by which decisions on extrap- o

关键词： new drugs ethnic factors bridging study clinical trials PK/PD ICH E5 guidance

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Quantitative assessment of drug effect on QT interval:Mixed effect modeling as a practical solution to interpret drug effect in the midst of high QT variability

Quantitative assessment of drug effect on QT interval:Mixed ...

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中国药理学会临床药理学专业委员会会议暨第十次全国临床药理学学术会议

作者： Charles Oo Asubio Pharmaceuticals Inc 395 West Passaic StreetRochelle ParkNJ 07662USA

QT prolongation is recognized as a risk factor for car- diac arrhythmia and torsades de *** QT cor- rection is essential for unbiased estimation of drug effect. However,evaluation of drug effect on QTc is challenging due to multiple source of variability and low precision of QT measures resulting in low signal to noise ratio,high between individual and between occasion variabilities,the presence of circadian rhythm and inadequacy of fixed cor- rection methods such as Bezette’s and Fredericia’s. “Standard”QT analytical methods include 1)largest time- matched mean difference between the drug and placebo (baseline subtracted)over the collection period,2)time- averaged QT/QTc intervals for each individual,3)analysis for changes occurring at Cfor each ***- er,the“standard”methods have limitations:1)do not provide quantitative information on QT prolongation,po- tency & activity,2)unable to simulate most critical situ- ation ***-therapeutic concentration,and 3)time averaging substantially reduces the .sensitivity of the test. Quantitative PK/PD analysis could reduce the risk of false-positive or false-negative signals,and could differen- tiate drug effect from the multiple source of *** allows for splitting the overall variability into components and estimate them with sufficient precision in order to pro- vide more reliable assessment of the drug induced QT pro- *** addition,quantitative PK/PD analysis allows for determining the model-based correction factor α.With adequate data per individual per study day(10-15), mixed effect modeling allows for the determination of sub- ject-specific αi,QTc for a j-th measurement for an i-th in- dividual :QTc=QT ij/*** the QTc data are limited for individuals,a population corrector factor could be de- *** rate and QT could be subject to circadian rhythm,and can be modeled by 1 or more cosine function with different periods:QT=QT*RR*(1+CIR- C)*(1+ε),where QTcmi is an indi

关键词： QT prolongation variability precision circadian rhythm mixed effect modeling

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Rui-Yuan Sun, Qing-shan *** Concepts of Mathematical ***:People's Medical Publishing House;2004.686 pages,RMB 43.00(≈＄5.19, paperback)ISBN. 7-117-06110-3/R·6111

Rui-Yuan Sun, Qing-shan *** Concepts of Mathematical ***:Peo...

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中国药理学会临床药理学专业委员会会议暨第十次全国临床药理学学术会议

作者： HUANG Xiao-hui

Contemporary pharmacological research has two pro- nounced trends:one trend is from the “macro” to the “micro”.The frontier of medical research is on the cellu- lar,molecular,and genetic level,which allow people to access the pharmacological arcanum more and more exact- *** important trend is from the “qualitative” to the “quantitative”.With the development of research,the

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β1肾上腺素受体与CYP2D6基因多态性对美托洛尔抗高血压治疗的药代动力学和药效学影响(英文)

β1肾上腺素受体与CYP2D6基因多态性对美托洛尔抗高血压治疗的药...

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中国药理学会临床药理学专业委员会会议暨第十次全国临床药理学学术会议

作者： LIU Jie LIU Zhao-qian LIU Ying-zi TAN Zhi-rong HU Dong-li LI Zhi WANG Dan ZHANG Wei ZHOU Hong-hao Pharmacogenetics Research Institute,Institute of Clinical Pharmacology,Central South University,Changsha 410078,Hunan,China

背景：美托洛尔是临床常用的抗高血压药物,它经由 CYP2D6代谢。CYP2D6*10降低 CYP2D6活性,是中国人群中最为常见的多态性。β 肾上腺素受体为美托洛尔的作用靶标,Ser49Gly 与 Gly389Arg 多态性显著改变受体功能。CYP2D6与β 肾上腺素受... 详细信息

背景：美托洛尔是临床常用的抗高血压药物,它经由 CYP2D6代谢。CYP2D6*10降低 CYP2D6活性,是中国人群中最为常见的多态性。β 肾上腺素受体为美托洛尔的作用靶标,Ser49Gly 与 Gly389Arg 多态性显著改变受体功能。CYP2D6与β 肾上腺素受体遗传多态性对美托洛尔降压疗效的联合影响仍属未知。目的：发现与美托洛尔药代动力学与药效动力学相关的基因多态性位点。为提高高血压痛的疗效和减少不良反应提供实验依据。方法：符合 WHO/ISH 高血压诊断标准的轻、中度高血压患者125例,服用美托洛尔单药治疗12周,每四周检测血压。在临床观察疗效的同时,应用 PCR- RFLP 方法对患者进行 CYP2D6*10与β肾上腺素受体 Ser49Gly 和 Gly389Arg 基因型分析。同时抽取静脉血5mL,高效液相色谱-荧光检测法测定患者美托洛尔谷浓度。结果：美托洛尔谷浓度与 CYP2D6 *10基因型显著相关,并呈基因剂量效应。但高血压患者血压降低程度在 CYP2D6*1*1、*1*10 与 CYP2D6*10*10组间无差异。Gly49携带者服用美托洛尔后收缩压与舒张压的降低显著大于 Ser49Ser 纯合子;与 Gly389携带者相比,Arg389Arg 服用美托洛尔后收缩压与舒张压的降低更为显著, 表明 Gly49与 Arg389型受体对美托洛尔治疗有较好的敏感性。结论：CYP2D6*10突变显著改变美托洛尔的药代动力学,但对美托洛尔的降压效果无显著性影响。β肾上腺素受体遗传多态性与β受体阻滞药的降压敏感性有一定相关性。

关键词： CYP2D6 β1肾上腺素受体遗传多态性原发性高血压美托洛尔

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Population pharmacokinetic/pharmacodynamic analysis for Pegylated Recombinant Human Growth Hormone(PHA-794428) in male healthy volunteers

Population pharmacokinetic/pharmacodynamic analysis for Pegy...

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中国药理学会临床药理学专业委员会会议暨第十次全国临床药理学学术会议

作者： Didier Eric Harris Philip Milligan Peter A Karlsson Mats O PGRD Sandwich UK Clinical Pharmacometrics Pfizer Global Research & Development(PGRD) SandwichUK Department of Pharmaceutical Biosciences Uppsala University Sweden

AIM:The purpose of this analysis was to construct approp- riate models to characterise population pharmacokinetics (PK)for PHA-794428 and PK/pharmacodynamics(PD) for the efficacy biomarker Insulin-like Growth factor-1 (IGF-1). METHODS:Fifty-six male healthy volunteers were en- rolled into a clinical *** received in a random- ised manner 3 subcutaneous injections over 3 periods:i) 3.6 mg recombinant human growth hormone(rhGH),ii) PHA-794428 0,3,10,30,60,100,300 or 500μg/kg, and iii)PHA-794428 0,10,or 30μg/*** PK and IGF-1 data were collected up to 336 h *** PK and PK/PD models were constructed in 3 stages:i)the PK model was developed,ii)the PK parameters were fixed during IGF-1 model building,iii)PK and IGF-1 da- ta were analysed simultaneously. RESULTS:PHA-794428 exhibited non-linearity with re- spect to dose.A one-compartment disposition model with parallel linear and non-linear elimination most appropriate- ly described the PHA-794428 serum concentrations versus time *** absorption of PHA-794428 was character- ised as a first-order process involving two absorption rate *** nonlinear elimination,characterised in terms of the maximal elimination capacity(V=91.5 μg/h for 70 kg)and Michaelis-Menten constant(K= 73.9μg/L)describing the concentration at which elimina- tion is at half *** non-linear elimination pathway is approximately 10 times higher than the linear route(0.129 L/h).PHA-794428 has a limited distribution in the blood (V=4.4 L),due to its large molecular *** IGF-1 concentrations versus time data were best described by an indirect response model with PEG-hGH stimulating IGF-1 production *** effect was appropriately char- acterised by a maximum effect(E)*** maxi- mal IGF-1 production rate could increase up to 8-fold across the dose range *** PHA-794428 concen- tration at half Emax(EC)is 56.5 ng/mL.A negative feedback loop was incorporated into the PK/IGF-1 model. The maximal inhibition(I)

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药物动力学/药效动力学在研究药物相互作用中的应用—反应曲面模型法研究瑞芬太尼与七氟醚联合应用(英文)

药物动力学/药效动力学在研究药物相互作用中的应用—反应曲面模...

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中国药理学会临床药理学专业委员会会议暨第十次全国临床药理学学术会议

作者： YANG Lu~1 YANG Ba-xian~2 ZHANG Li-ping~1 BI Shan-shan~3 LU Wei~(3,4) 1 Department of Anesthesiology,Third Hospital,Peking University,Beijing 100083,China 2 Department of Anesthesiology,People’s Hospital,Peking University,Beijing 100083,China 3 Deptartment of Pharmaceutics,School of Pharmaceutical Science,Peking University,Beijing 100083,China 4 State Key Lab.of Natural and Biomimetic Drugs,Beijing 100083,China

目的：全麻中两种以上的药物合并应用比单一麻醉剂更为有效。本研究是为确定中国成年患者全麻期间合并应用七氟醚与瑞芬太尼时药物相互作用的方式,并以反应曲面模型法对其进行表述。方法：1．试验设计：研究采用平行实验设计,65例病人(A... 详细信息

目的：全麻中两种以上的药物合并应用比单一麻醉剂更为有效。本研究是为确定中国成年患者全麻期间合并应用七氟醚与瑞芬太尼时药物相互作用的方式,并以反应曲面模型法对其进行表述。方法：1．试验设计：研究采用平行实验设计,65例病人(ASA Ⅰ级,各项指标正常,无长期服用阿片类药物史)入选本次试验,随机选定并维持一定的呼末七氟醚浓度[≤2MAC(0．3％-3．4％)],逐渐增加靶控输注的瑞芬太尼浓度(≤10 ng/mL),观察不同浓度组合时患者对喉镜置入刺激的反应以确定麻醉是否完全。2．反应曲面模型法进行药物动力学/药效动力学分析：两药合用的效果通过对喉镜置入时的反应进行评估,0和1分别代表有或没有体动反应。以下面的药效学模型表述体动反应消失的概率(P) 其中 Us,Ur 分别为标准化的七氟醚与瑞芬太尼水平;U为达最大效应一半时的药物综合标准化水平;r 为形状因子;I(Q)为药物相互作用的强度函数。模型通过作图、目标函数改变以及参数的生理/ 临床学的合理性等几方面进行评价。 p=((Us+Ur))/([U/I(Q)]+(Us+Ur)) 结果与结论：研究表明瑞芬太尼与七氟醚合用时为协同式相互作用,上述反应曲面模型与实际观测值有较好的拟合。应用 NONMEM 得到喉镜置入刺激时的参数(RSE%)为 U=6．62(10．6),C= 1．71%(12．9),C=12．4 ng/mL(19．0),I= 2．31,Q=0．706。所得数值的加权残差均小于3。结果表明与传统方法相比,反应曲面模型法可以得到较好的拟合质量,为药物相互作用的研究提供了一种新颖思路和有效手段。

关键词： drug-drug interactions synergy response-surface

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Spectral data analysis and identification of Thymopentin

Spectral data analysis and identification of Thymopentin

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中国药理学会临床药理学专业委员会会议暨第十次全国临床药理学学术会议

作者： YU Li-jun~1 ZHANG Fu-zhong~2 1 College of Clinical Medicine,Inner Mongolia University for Nationalities,Tongliao 028000,Inner Mongolia,China 2 Tongliao Entry-Exit Inspection and Quarantine Bureau,Tongliao 028000,Inner Mongolia,China

AIM:To provide a basis for nuclear magnetic resonance (NMR)characterization of polypeptide compounds. METHODS:The H,C NMR and 2D NMR spectra were used to characterize *** using infrared (IR),ultraviolet(UV),mass spectrometry(MS)tech- niques,along with H- H correlation spectrometry(CO- SY)and distorsiouless enhancement by polarization trans- fer(DEPT),the proton and carbon-13 spectra were as- signed completely. RESULTS:The Thymopentin was characterized based on the methods described above. CONCLUSION:The target molecule is confirmed and the structure is identified.

关键词： nuclear magnetic resonance spectra elucidation Thymopentin

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Development and validation of a selective and robust LC-MS/MS method for quantifying ilaprazole and its metabolite ilaprazole sulfone in human plasma

Development and validation of a selective and robust LC-MS/M...

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中国药理学会临床药理学专业委员会会议暨第十次全国临床药理学学术会议

作者： TAN Zhi-rong ZHANG Wei ZHOU Gan CHEN Yao GUO Dong HE Yi-jing CHEN Ying LI Ya-lin WANG Dan ZHOU Hong-hao Pharmacogenetics Research Institute,Institute of Clinical Pharmacology,Central South University,Changsha 410078,Hunan,China

A liquid chromatography-tandem mass spectrometric method(LC-MS/MS)for quantifying ilaprazole and its ma- jor metabolite in human plasma was developed and validat- *** preparation was based on chloroform extrac- *** was performed on a Canalytical column and the retention times were 1.2,1.28 and 1.65 min for ilaprazole,ilaprazole sulfone and omeprazole(in- ternal standard),*** ionization was opti- mized using ESI(+)and enhanced selectivity achieved by tandem mass spectrometric *** calibration curve ranged from 0.36 to 368.40 ng/mL and from 0.125 to 128.000 ng/mL for ilaprazole and ilaprazole sulfone, *** intra-and inter-day precision(CV)were within 15%,and accuracy of ilaprazole and ilaprazole sul- fone were within 80% to 120%.The analytes showed sta- ble over the timescale of the whole *** robust- ness of the method was demonstrated by good reproducibili- ty of results obtained from the analysis of clinical samples.

关键词： mass spectrometry ilaprazole ilaprazole sulfone

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Bioequivalence study of fusidicacid suspension in healthy volunteers

Bioequivalence study of fusidicacid suspension in healthy vo...

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中国药理学会临床药理学专业委员会会议暨第十次全国临床药理学学术会议

作者： HAN Yang TAN Zhi-rong OUYANG Dong-sheng ZHOU Hong-hao Institute of Clinical Pharmacology,Xiangya Medical College,Central South University,Changsha 410078,Hunan,China

AIM:To study the relative bioequivalence of fusidic acid suspension and its contrastive suspension. METHODS:A single oral dose of 750 mg domestic fusid- ic acid suspension,and its contrastive suspension were given to 20 healthy volunteers in an open randomized and two way crossover *** plasma concentrations were determined by HPLC method. RESULTS:The main pharmacokinetic parameters were as follows:Cwere(31±5)and(30±6)μg/mL;t were(2.0±0.7)and(1.9±0.6)h;AUCwere (43±136)and(436±105)μg·mL·h;AUC were(460±140)and(451±108)μg·mL·h for the reference suspension and the test suspension,respectively. The relative hioavailability of domestic fusidie acid suspen- sion was 100%±13%. CONCLUTION:Statistic analysis shows that the refer- ence preparation and the test preparation were bioequiva- lent.

关键词： fusidic acid relative bioavailability HPLC

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