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Assessment of absolute oral bioavailability of linezolid tablets in Chinese healthy male volunteers

Assessment of absolute oral bioavailability of linezolid tab...

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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： SHI Yao-guo ZHANG Jing YU Ji-chen CAO Guo-yin ZHANG Yin-yuan Institute of Antibiotics,Huashan Hospital,Fudan University,Shanghai 200040,China

AIM:Linezolid is a member of oxazolidinones,which is a novel class of *** study is to determine the absolute bioavailability of linezolid tablets in Chinese healthy male volunteers. METHODS:A randomized,open cross-over study was conducted in 22 healthy male volunteers,a single oral dose of 600 mg linezolid tablets or Ⅳ infusion of 600 mg linezolid were given to subjects,*** sam- ples were obtained at different time points and sent to American AvTech *** concentrations of linezolid were determined by high-performance liquid chro- matography（HPLC）,pharmacokinetic parameters and ab- solute bioavailability were calculated. RESULTS:After oral and IV infusion administration of 600 mg linezolid,the elimination half-life(t)was（4.3 +1.0）h and（4.4±0.9）h,*** area un- der plasma concentration-time curve(AUC)of lin- ezolid were（87±20）μg·mL·h and（96±21） μg·mL·h,*** absolute oral bioavailabili- ty was 93%±23% following single oral dose of 600 mg linezolid *** of two one-sided t tests and 90% confidence interval showed that linezolid tablet and Ⅳ formulation are equivalent with respect to *** ad- verse event was found except one volunteer with transitory mild epigastric pain. CONCLUSION:Linezolid tablets can be completely ab- sorbed;it is equivalent in extent of absorption to its Ⅳ formulation.

关键词： linezolid tablet bioavailability

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A contemporary view of bioequivalence and therapeutic equivalence

A contemporary view of bioequivalence and therapeutic equiva...

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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： CHEN Mei-lin Center for Drug Evaluation and Research (CDER),Food and Drug Administration

Bioequivalence studies play an important role in the drug development as well as during the post-approval peri- od for both new drugs and generic *** principle,the goals of these studies are two-fold:(1)serve as bridging studies to provide supportive evidence for safety and effica- cy of a drug product;and(2)ensure product quality and performance throughout the life time of a drug product in the presence of changes in formulation or manufacturing. Additionally,in the context of generic drugs,the current *** dictates that evidence of bioequivalence and pharmaceutical equivalence provides the assurance of therapeutic equivalence,hence interchangeability. The conventional wisdom for bioequivalence studies indicates that the testing is best performed using the most accurate,sensitive,and reproducible approach available for the drug under ***,to date, comparative pharmacokinetic studies have been used in most cases for bioequivalence *** vitro tests are seldom utilized while pharmacodynamic studies and clinical trials are employed for locally acting drug products or when drug levels cannot be measured in the *** trend,however,is changing with the recent advances in pharmaceutical science and *** example,the introduction of the Biopharmaceutics Classification System (BCS)has provided a valuable tool for predicting drug ab- sorption and *** rapidly growing knowl- edge of pharmacogenetics/genomics combined with formu- lation science may facilitate a better understanding of the potential interplay between pharmaceutical characteristics and biological system in *** the future,an en- hanced prediction and assessment of bioequivalence may be achieved through the rational design of formulations and use of in vitro,in situ or in silico test methods. Implicit in the inclusion of pharmaceutical equiva- lence as part of the definition of therapeutic equivalence has been the regulatory objective

关键词： generic drug bioequivalence therapeutic equivalence Biopharmaceutics Classification System(BCS) in vitro in vivo

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Metabolism and transport of drugs and Chinese herbal medicines: from molecule to malady

Metabolism and transport of drugs and Chinese herbal medicin...

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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： ZHOU Shu-feng Division of Chinese Medicine,School of Health Sciences,WHO Collaborating Centre,RMIT University,Melbourne,Victoria 3083,Australia

Detailed ADME(absorption,distribution,me- tabolism and excretion)evaluation is required in the pre- clinical stage of drug *** preclinical ADME data may be extrapolated to humans and some predictions may be made with the application of proper phannacokinet- ic and pharmacodynamic *** drugs with vali- dated drug targets and favorable ADME properties are be- ing sought by drug scientists,and oral administration is becoming a major delivery approach for many drugs due to its great safety,reduced cost,improved quality of life, and the potential for improved *** incorporation of herbal therapy into the main stream medical-care system has been encouraged by World Health Organization (WHO).Chinese herbal medicines may represent an im- portant group of multi-component therapeutics suitable for the management of diseases with networked abnormalities such as cancer and ***,the disposition pathways,pharmacological targets and safety profiles of most Chinese herbal medicines are unknown or not well *** evidence for the use of Chinese herbal medicines as effective and safe multi-component therapeu- tics is not *** quality control and standardiza- tion of these natural products still constitute a major chal- lenge in their evidence-based clinical ***- cently,there is an increased interest in the incorporation of systems biology approaches and combined use of preclini- cal and clinical models in understanding the complex dis- position pathways,multiple targets and toxicities of Chi- nese herbal *** synthetic drugs,Chinese herbal medicines are subject to similar ADME processes in the body like synthetic ***,data are scant on the ADME of most Chinese herbal ***,it is important to characterize ADME for both drugs and Chi- nese herbal *** research team and collaborators have synthesized several small molecule novel compounds for cancer treatment,including 5,6-di

关键词： drug metabolism drug transport ADME Chinese herbal medicine P-glycoprotein elimi- nation multicomponent therapeutics

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A 3D-QSAR study of catechol-O-methyltransferase inhibitors using CoMFA and CoMSIA

A 3D-QSAR study of catechol-O-methyltransferase inhibitors u...

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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： AI Chun-zhi YANG Ling Lab of Pharmaceutical Resource Discovery,Dalian Institute of Chemical Physics,Graduate School of the Chinese Academy of Sciences,457 Zhongshan Road,Dalian 116023,Liaoning,China

AIM:Inhibitors of catechol-O-methyhransferase（COMT） have always been administered to improve the bioavailabili- ty of L-Dopa in the treatment of Parkinson disease（PD）. A new three-dimensional quantitative structure-activity re- lationship（3D-QSAR）analysis is performed to correlate the molecular fields with percent inhibition values. METHODS:Three predictive models were derived based on 36 previously reported COMT inhibitors employing com- parative molecular field analysis（CoMFA）and compara- tive molecular similarity indices analysis（CoMSIA）meth- odologies. RESULTS:The CoMFA model and CoMSIA model with sterie and electrostatic field yielded cross-validated r 0.585 and 0.528 respectively,whereas the conventional r were 0.979 and *** CoMSIA model with hy- *** field exhibited r0.544 and r0.930. CONCLUSION:The derived models from CoMFA and CoMSIA 'all exhibit good prediction tor both intemal and extemal *** individual inspection of 3D cont- ours generated from these models helps in understanding the possible region for structural modification of molecules to improve the inhibitory *** 3D-QSAR mode- ls may be useful in designing and predicting novel COMT inhibitors.

关键词： catechol-O-methyltransferase inhibitor quantitative structure-activity relationships(QSAR) comparative molecular field analysis(CoMFA) comparative molecular similarity indices analysis(CoMSIA)

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Safety,tolerability and pharmacokinetic study of recombinant human parathyroid hormone in healthy male Chinese subjects

Safety,tolerability and pharmacokinetic study of recombinant...

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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： LI Wei-yong LI Qian QIAO Jian DENG Jun-gang ZHANG Ying Institute of Clinic Pharmacy,Union Hospital Affiliated to Tongji Medical College,Huazhong University of Science & Technology,Wuhan 430022,Hubei,China

AIM:To determine the safety,tolerability and pharmaco- kinetic parameters of a new drug recombinant human para- thyroid hormone [rhPTH（1-84）] in healthy male Chinese subjects. METHODS:Thirty-six healthy male volunteers were ran- domly divided into 3 *** volunteers in these groups received single subcutaneous injection of rhPTH（1- 84）in a dosage of 1,2 and 4 μg/kg *** samples were obtained before and after administration with- in 24 *** rhPTH concentrations in serum were de- termined by enzyme linked immunosorbent assay （ELISA）.The pharmacokinetic parameters determined with use of standard noncompartmental analysis were the maximum serum concentration(C),the time to attain that concentration(t),and the area under the serum concentration-time curve up to 24 hours(AUC)and up to infinity(AUC).Dose proportionality of phar- maeokinetic parameters(AUC,Cof every volunteer of each dosage and AUC was computed from log transformed data)and was examined by mean of analysis of variance （ANOVA）using SPSS software *** the study, subjects' symptoms,objective signs,and vital signs,in- cluding blood pressure,heart rate,respiratory rate and body temperature,were checked and 12-lead electrocar- diography was recorded before and after drug administration within 24 *** laboratory tests,including hema- tology,blood biochemistry,serum electrolyte,and urinal- ysis,were performed before and after drug administration within at 24 hours. RESULTS:The specificity,sensitivity,linear range, precision and accuracy of the method were all satisfied for the determination of rhPTH in *** serum concen- tration-time curve of most volunteers clearly exhibited a double-peak profile,with the first peak appearing approxi- mately 10 to 30 minutes and the second peak appearing ap- proximately 1.5 to 2 hours after subcutaneous injection of the *** concentrations of all subjects 24 hours after dosing in the three groups almost returned to physio- logic p

关键词： recombinant human parathyroid hormone tolerability safety pharmacokinetics single dose

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In vitro pharmacokinetics and pharmacodynamics of Ievofloxacin against plasmid-mediated quinolone resistant Escherichia coli

In vitro pharmacokinetics and pharmacodynamics of Ievofloxac...

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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： XU Jun-fang WU Xiao-jie WANG Ming-hua XU Xiao-gang WANG Ming-gui ZHANG Jing.Institute of Antibiotics,Huashan Hospital,Fudan University,Shanghai 200040,China

AIM:Bacterial resistance to quinolones has traditionally mediated by alteration of the quinolone targets and/or over- production of efflux ***,a new mechanism, the plasmid-mediated quinolone resistance named qnr,has been *** and its homologus are widely distribut- ed among gram-negative *** presence of qnr only slightly elevates the resistance level,however it facili- tates the selection of highly resistant *** our study, we examined the probable influence of such phenomenon to the clinical regimens of levofloxacin. METHODS:In-vitro hollow fiber infection model simu- lating oral two-compartment pharmacokinetic model was es- *** the model,bacteria was incubated in the pe- ripheral compartment without‘washout effect’.We de- signed two therapeutic regimens of levofloxacin,including 500 mg qd（peak 5.12 mg/L;half-time 6.9 h）and 700 mg qd（peak 9.46 mg/L;half-time 6.9 h）for 3 days against *** J53 and *** 650,which carrying qnr positive plasmid. RESULTS:Although 500 mg qd regimen could decrease the bacteria density of *** 650 at the beginning, the bacteria population bounced back when the drug con- centration was drecreased below 2 mg/L,and the regrowth bacteria had higher MICs than the parental strains.700 mg qd for 3 days could inhibit the outgrowth of *** 650 all the *** J53 was well inhibited by both the mentioned therapeutic *** sequencing found the mutations in QRDR of *** 650. CONCLUSION:We conclude that 500 mg qd which is the most popular regimen is at risk of selecting resistant mutations and treatment failure while treating the infections caused by qnr positive ***,and 750 mg qd might be *** vivo pharmacodynamic studies to support our findings are warranted.

关键词： levofloxacin pharmacokinetics and pharmacodynamics plasmid-mediated quinulone resistance

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Study on effects of cinobufagin on the immunologic function of mice in vitro

Study on effects of cinobufagin on the immunologic function ...

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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： SONG Yu~(1,2) JIANG Feng~1 WANG Da-cheng~1 ZHU Tong-fei~1 HAN Xiao-hu~1 ZHAO Wen-jie~2 DENG Xu-ming~1 1 College of Animal Science and Veterinary Medicine,Jilin University,Changchun 130062,Jilin,China 2 National Standard Laboratory of Pharmacology for Traditional Chinese Medicine,Jilin Natural Pharmatech Co.Ltd,Changchun 130012,Jilin,China

AIM:To investigate the immunoregulatory effects of cinobufagin from the chloroform extract of Venenum Bufo- nis,a famous traditional Chinese medicine in vitro. METHODS:Proliferation of the splenic lymphocytes in Balb/c mice was measured by MTT *** metaboilic level and phagotrophic activity of PMΦ were also deter- mined by MTT *** expressions of CD and CD and cell cycle of the splenic lymphocytes were detected by flow Cytometry. RESULTS:Administration of cinobufagin or coadminis- tration with Con A or LPS increased the cell proliferation and the percentage of S phase cells in the splenic lympho- cytes at a dose-dependent manner（P＜0.05 or P＜ 0.01）.Cinobufagin also enhanced the metabolic capability of MTT and the phagocytosis function of PMΦ（P＜0.05 or P＜0.01）.In addition,it was found that the single administration of cinobufagin or coadministration with Con A or LPS also could increase expressions of CD and CD in T lymphocytes（P＜0.05 or P＜0.01）. CONCLUSION:Single administration of cinobufagin or coadministration with Con A or LPS could enhance the re- active ability to the splenic lymphocytes and PMΦ in mice. The data indicate that the immunoregulatory effect of cinobufagin is related to the increased expression of CD and CD in DP（double positive）phenotype and S phase cells of T lymphocytes.

关键词： Venenum Bufonis Cinobufagin lymphocytes peritoneal macrophage CD4 CD8 S phase

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Effects of florfenicol on early cytokine response and survival in a murine septic shock model

Effects of florfenicol on early cytokine response and surviv...

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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： ZHANG Xue-mei~(1,2) SONG Yu~1 DENG Xu-ming~1 AN Na~1 CI Xin-xin~1 1 Department of Pharmacology,College of Animal Science and Veterinary Medicine,Jilin University,Changchun 130062,Jilin,China 2 Department of Animal Medicine,Agricultural College of Yanbian University,Yanbian 133400,Jilin,China

AIM:To study the effects of florfenicol on early cytokine response and survival in treatment of infected murine in- duced by septic shock. METHODS:The effect of florfenicol on cytokine produc- tion from lipopolysaccharide(LPS)-stimulated macrophag- es was investigated by using a mouse macrophage cell line. The influence of florfenicol on the survival rate of mice in- jected with lethal dose of endotoxin and early cytokine re- sponses in endotoxemia mice were *** serum cytokine productions of mice were determined at different time points. RESULTS:Florfenicol significantly reduced the produc- tions of tumor necrosis factor(TNF)and interleukin-6 (IL-6)in the supernatant of cells as well as slightly atten- uated the secretions of interleukin-1β(IL-1β)and interleu- kin IL-10(IL-10).No significant difference in IL-1β con- centration was observed between florfenicol-treated group and control ***,florfenicol significantly in- creased serum IL-10 concentration of ***,it was found that florfenicol(at the dose of 100 mg/kg)signifi- cantly increased the survival rate of mice compared to the control group after mice were administrated LPS. CONCLUSION:These data indicate that florfenicol can improve survival rate of endotoxemia mice via modulating early cytokine responses and antibiotics mighty be of po- tential usefulness in treatment of bacterial shock.

关键词： florfenicol lipopolysaccharide(LPS) cytokines mice survival rate

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Pharmacokinetics of theophylline in patients with COPD and its interference factors

Pharmacokinetics of theophylline in patients with COPD and i...

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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 Xiao-ming Department of Pharmacy,the First Affiliate Hospital of Hebei North University,Zhangjiakou 075000,Hebei,China

AIM:To study the pharmacokinetics of theophylline in patients with chronic obstructive pulmonary diseases （COPD）and its interference factors. METHODS:Serum theophylline concentrations in 9 pa- tients with COPD after oral administration of theophylline （200 mg,tid）for 5 consecutive days or combining with nifedipine（10 mg,tid）for 5 consecutive days were deter- mined by high performance liquid chromatography（HPLC） with ultraviolet spectrophotometry. RESULTS:The pharmacokinetics of theophylline in COPD patients was one-compartment model after oral ad- ministration of theophylline（200 mg,tid）for 5 consecu- tive *** significant difference in individual variation on phannacokinetics of theophylline was observed in this *** volume of distribution（V）was（0.50± 0.21）L/kg,the elimination half-life(t)was（5.4± 1.3）h and clearance（CL）was（0.07±0.03） L·h·kgin the patients with *** was no significant difference in V,t,and CL between COPD patients and healthy volunteers（P＞0.05）.The values of k and Cl were faster and twas shorter in the middle- aged patients than those in old COPD patients（P＜ 0.05）.After administration of nifedipine for 5 consecutive days,the mean serum theophylline concentration de- creased by（1.8±2.0）mg/*** Cand AUC were,Iower than those obtained before nifedipine[（12±6） vs（10±5）mg/L,（82±52）vs（62±39）mg·L·h, P＜0.05 ],*** this study,the mean serum concentration of theophylline determined by UV method was significantly lower than that by HPLC [△C=（-0.6 ±1.6）mg/L,n=123,P＜0.05].However,the phar- macokinetic parameters of theophylline determined by the two methods were no difference（P＞0.05）.In addition, the results showed that there was no significant change in theophyiline recovery,in pure serum of theophylline and mixture serum of theophylline and CTRX. CONCLUSION:The pathological state of COPD appears not to affect the pharmacokinetic profiles in middle-aged patients with *** is not necessary to change the ther- apeutic combination wi

关键词： chronic obstructive pulmonary diseases theophylline pharmacokinetics interaction HPLC UV

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Plasma level of AcMPAG in renal transplant recipients is related to the polymorphism of UGT2B7 211G＞T

Plasma level of AcMPAG in renal transplant recipients is rel...

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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： ZHANG Wei-xia~1 CHEN Bing~1 YU Zi-cheng~1 JIN Zhao~1 WANG Xiang-hui~2 CAI Wei-min~1 1 Institute of Clinical Pharmacology,Ruijin Hospital,School of Medicine,Shanghai Jiaotong University,Shanghai 200025,China 2 Organ Transplantation Center,Ruijin Hospital,School of Medicine,Shanghai Jiaotong University,Shanghai 200025,China

AIM:To clarify whether Mycophenolic acid（MPA）or its metabolite AcMPAG can cause gastrointestinal disturbanc- es,and to explore the effect of UGT2B7 SNP 211G＞T on the pharmacokinetic of AcMPAG. METHODS:Twenty-four renal transplant patients were enrolled in this *** study was per- formed on day 14 after transplantation and symptoms were recorded on the same *** blood samples were collected before dosing and 0.5,1,1.5,2,4,6,8,10 and 12 hours after morning *** concentrations of MPA,MPAG and AcMPAG were detected by HPLC. Genotype of UGT2B7 211G＞T was determined using PCR-RFLP method. RESULTS:No significant difference was observed be- tween patients with and without side effects for AUC of MPA and *** values of AUC/dose of MPA,MPAG and AcMPAG were（39.7±12.3）, （1063.7±646.5）and（10.2±3.0）ng·h·mL·mg in TT genotype group and（42.0±20.0）,（1466.5± 683.3）and（20.7±5.6）ng·h·mL·mgin GG gen- otype group,*** ratio of AUC_(（AcMPAG）(0-12))/ AUC,which was used to describe the change of UGT2B7 enzyme activity,was 0.49±0.20,0.34±0.26 and 0.28±0.14 in recipients with 211GG,GT and TT genotype,respectively（P＜0.05）. CONCLUSION:There was no significant differences in pharmacokinetics of MPA and its metabolites between side effect group and non-side effect *** seems that the polymorphism 211G＞T in the UGT2B7 gene results in the reduction of enzyme acitivity.

关键词： UDP-glucuronosyltransferase 2B7 MPA AcMPAG polymorphism adverse effect

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