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Effect of Rhei Radix et Rhizoma and Eupolyphaga Steleophaga on liver protection mechanism based on pharmacokinetics and metabonomics

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Chinese Herbal Medicines 2024年第1期16卷 121-131页

作者： Gang Feng Jianli Bi Wenfang Jin Qi Wang Zhaokui Dan Baolei Fan Hubei University of Science and Technology Xianning 437100China The First People’s Hospital of Xianning Xianning 437000China The First People’s Hospital of Tongshan Tongshan 437600China Hubei Provincial Key Laboratory of Radiation Chemistry and Functional Materials Xianning 437100China

Objective:Based on metabonomics technology of high-performance liquid chromatography-mass spectrometry(HPLC-MS/MS)and hydrogen nuclear magnetic resonance spectroscopy(^(1)H NMR),the pharmacokinetic characteristics and therapeutic mechanism of Rhei Radix et Rhizoma(RhRR,Dahuang in Chinese),Eupolyphaga Steleophaga(EuS,Tubiechong in Chinese)combined with RhRR acting on acute liver injury were ***:Models of acute liver injury were established,and the pharmacokinetic methods of five components of RhRR-EuS in rats were found by HPLC-MS/*** liver tissues of different groups of mice were analyzed by ^(1)H NMR spectroscopy combined with multivariate statistical analysis to investigate the metabolomics of RhRR-EuS and ***:Pharmacokinetic results showed there were different levels of bimodal phenomenon in different groups,and the absorption of free anthraquinone in RhRR increased after compatibility with *** addition,the pathological state of acute liver injury in rats can selectively promote the absorption of emodin,chrysophanol,physcion and aloe *** 15 differential metabolites in the liver tissue of acute liver injury mice,it was revealed that RhRR-EuS and RhRR could protect the liver injury by regulating the metabolism of glutamine and glutamic acid,alanine,aspartic acid and glutamic acid,and ***,the regulation of RhRR was weaker than that of ***:For the first time,we studied the pharmacokinetics and metabolomics differences of RhRREuS and RhRR in rats and mice with acute liver injury,in order to provide theoretical reference for clinical treatment of liver disease by DHZCP.

关键词： Dahuang Zhechong Pills Eupolyphaga Steleophaga 1H NMR HPLC-MS/MS metabonomics pharmacokinetics Rhei Radix et Rhizoma

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Comparative pharmacokinetics of six components in normal and rheumatoid arthritis rats after intragastrical administration of Qianghuo Shengshi Decoction granules by LC-MS/MS

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Chinese Herbal Medicines 2024年第3期16卷 457-465页

作者： Xin Li Min Wang Yuhong Zhong Qianqian Yin Zheming Hu Wenli Tian Zhongyan Liu Zhidong Liu Engineering Research Center of Modern Chinese Medicine Discovery and Preparation Technique Ministry of EducationTianjin University of Traditional Chinese Medicine State Key Laboratory of Component-based Chinese Medicine Tianjin University of Traditional Chinese Medicine Haihe Laboratory of Modern Chinese Medicine Tianjin University of Traditional Chinese Medicine

Objective:To investigate the plasma pharmacokinetics of six representative components(nodakenin,osthole,5-0-methylvisammioside,ferulic acid,liquiritigenin,and liquiritin),which were the ingredients of Qianghuo Shengshi Decoction(QSD) granules,in normal and rheumatoid arthritis(RA) rats administrated QSD granules ***:A rapid and accurate ultra-high performance liquid chromatography-tandem mass spectrometry(LC-MS/MS) method was developed for the simultaneous determination of six components in plasma,and it showed a good specificity,linearity,intra-day and inter-day precision,intra-day and inter-day accuracy,extraction recovery,stability,and the less matrix ***:The validated LC-MS/MS method was successfully used to compare the plasma pharmacokinetics of six ingredients between normal and RA rats after intragastrical administration of QSD granules and differences in the pharmacokinetics were found in two types of *** absorption rate in the RA rats was lower for nodakenin,osthole,5-0-methylvisammioside,liquiritigenin and liquiritin than in the normal group,while the absorption rate of ferulic acid remained constant in two *** comparison with the normal rats,the exposure concentration of nodakenin was higher and that of other five components except for nodakenin was lower under pathological ***,the absorptive amount of nodakenin,osthole,5-0-methylvisammioside and liquiritin was increased and that of ferulic acid and liquiritigenin was reduced in the RA rats than in the normal *** with the normal rats,the retention time of nodakenin,ferulic acid and liquiritin was reduced in vivo,whereas the retention time of osthole,5-0-methylvisammioside and liquiritigenin was raised in the body for the RA *** contrast to the normal rats,the data demonstrated an increase in the elimination velocity of nodakenin and a decrease in the elimination velocity of the other five components except for nodakenin in the pa

关键词： LC-MS/MS pharmacokinetics Qianghuo Shengshi Decoction granules rheumatoid arthritis

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pharmacokinetics and Bioequivalence Evaluation of Two Rosuvastatin Calcium 20 mg Tablets: A Single Oral Dose, Randomized-Sequence, Open-Label, Two-Period Crossover Study in Healthy Volunteers under Fasting Conditions

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Journal of Biosciences and Medicines 2024年第6期12卷 230-243页

作者： Evelyn Pena Alfredo Inatti José Gregorio Chacón Department of Clinical Research Industrias Biocontrolled C.A. Caracas Venezuela

Objectives: To compare the rate and extent of absorption of Racor® 20 mg (Rosuvastatin calcium 20 mg) tablet of Laboratorios Leti, S.A.V., with Crestor® 20 mg (Rosuvastatin calcium 20 mg) tablet of AstraZeneca, UK Limited in healthy adult human subjects under fasting conditions. Method: This was an open label, analyst blind, balanced, randomized, two-treatment, two-period, two-sequence, single oral dose, crossover, bioequivalence study in healthy, adult, human subjects under fasting condition. Twenty-four (24) subjects were planned as per the protocol and all subjects completed both periods of the study. The concentrations of Rosuvastatin in plasma were quantitated using a validated LC-MS/MS method of analysis and plasma levels were submitted for statistical analysis. Cmax, AUC0-t, AUC0-∞, Tmax, t1/2, Kel (hrs-1), percent AUC extrapolated [100 * (AUC0-∞ - AUC0-t)/AUC0-∞] (AUC_%Extrapobs) were calculated for rosuvastatin in plasma using SAS® version 9.1.3, SAS Institute. Inc. ***. ANOVA, 90% confidence interval using Schuirmann’s two one-sided test for bioequivalence, power and ratio analysis, for lntransformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ were computed and reported for Rosuvastatin in plasma for BE. Results: Data showed that 90% confidence intervals for the test/reference geometric mean ratios (GMR) of Cmax (95.01 - 112.66), AUC0-t (93.38 - 111.67) and AUC0-∞ (93.65 - 111.29) were within the BE (80% - 125%) acceptance range. Conclusions: Two products formulation, reference (R) Crestor® (rosuvastatin calcium) of AstraZeneca and test (T), Racor® (rosuvastatin calcium) of Laboratorios Leti S.A.V., with a single dose of 20 mg, under fasting conditions were bioequivalent. No severe, serious or unexpected adverse events (AEs) were reported in this study.

关键词： Bioequivalence Rosuvastatin pharmacokinetics

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GC-MS/MS Method for Determination and pharmacokinetics of Main Components of Cang-Ai Volatile Oil in Rat Plasma after Intravenous Administration

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Medicinal Plant 2024年第4期15卷 92-98页

作者： Wenyu MA Jincun LI Xuemei PAN Haoran NI Yuhuan XIE School of Chinese Materia Medica Yunnan University of Chinese MedicineKunming 650500China Yunnan Provincial University Key Laboratory of Aromatic Chinese Herb Research Kunming 650500China Yunnan Innovation Team of Application Research on Traditional Chinese Medicine Theory of Disease Prevention at Yunnan University of TCM Kunming 650500China

[Objectives]To establish a gas chromatography-triple quadrupole mass spectrometry(GC-MS/MS)method based on multiple reaction monitoring(MRM)mode for the analysis of the major components in Cang-ai volatile oil(CAVO).[Methods]An ultrasensitive gas chromatography-tandem mass spectrometry(GC-MS/MS)method was developed and validated for the determination of three highly abundant components in rat plasma *** was used as an internal standard.A multiple reaction monitoring(MRM)model was employed for the quantification of the three major components of CAVO.[Results]The method demonstrated linearity over the range of 0.25 to 50μg/mL with a correlation coefficient(R 2)greater than *** lower limit of quantification was 0.25μg/***-day and inter-day accuracy and precision were within 15%.Extraction recovery and matrix effect values ranged from 90.1%to 110.6%and 0.1%to 2.1%,respectively.[Conclusions]This method was successfully applied to the simultaneous determination of the three components in high-level CAVO plasma samples,providing a basis for subsequent studies of CAVO.

关键词： GC-MS/MS Cang-ai volatile oil MRM mode pharmacokinetics

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pharmacokinetics of fucoidan and low molecular weight fucoidan from Saccharina japonica after oral administration to mice

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Journal of Oceanology and Limnology 2023年第5期41卷 1900-1909页

作者： Jiaojiao TAN Yimin SONG Jing WANG Ning WU Yang YUE Quanbin ZHANG Key Laboratory of Experimental Marine Biology Center for Ocean Mega-ScienceInstitute of OceanologyChinese Academy of SciencesQingdao 266071China Laboratory for Marine Biology and Biotechnology National Laboratory for Marine Science and Technology(Qingdao)Qingdao 266237China University of Chinese Academy of Sciences Beijing 100049China Department of Pharmaceutical Engineering Qingdao University of Science and TechnologyQingdao 266000China Laboratory for Marine Drugs and Biological Products National Laboratory for Marine Science and Technology(Qingdao)Qingdao 266237China Nantong Zhongke Marine Science and Technology Research and Development Center Nantong 226000China

The brown seaweed,Sacchairna japonica,has been used in traditional Chinese medicine for over one thousand *** administration of fucoidan or low molecular weight fucoidan(LMWF)from *** could ameliorate kidney dysfunction in chronic kidney diseases and inhibit diabetic vascular *** many studies,LMWF was found to be more potent than fucoidan with high molecular ***,the pharmacokinetics of LMWF still remains *** purpose of the research is to compare the pharmacokinetics of fucoidan with high molecular weight(136 kDa)with that low molecular weight(9.5 kDa)after oral administration to ICR *** fucose is the main and representative monosaccharide of fucoidans,we evaluate the pharmacokinetics of fucoidan and LMWF by determining the fucose concentration in mice *** fucoidan and LMWF were absorbed following oral *** and LMWF were provided to mice by oral administration with 60 mg/kg and the maximum Concentration(C_(max))was found at 2.5 h(0.66±0.32 mg/L)for Fucoidan and 1.5 h(1.01±0.56 mg/L)for LMWF,*** seems that LMWF had a higher area under the curve(AUC_(0–t))and was absorbed more quickly than *** estimated bioavailability of LMWF was28.3%in the mice treated with a single dose of 30 mg/*** addition,LMWF was found widely spreaded into different tissues following oral administration and the highest concentration was found in kidney at 19.93±7.02μg/*** this study,we first studied the pharmacokinetics of LMWF,in order to help to understand the function of *** our results shed light on the potential of development of drugs based on LMWF.

关键词： fucoidan low molecular weight fucoidan pharmacokinetics bioavailability tissue distribution

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pharmacokinetics,distribution,and excretion of sodium oligomannate,a recently approved anti-Alzheimer's disease drug in China

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Journal of Pharmaceutical Analysis 2022年第1期12卷 145-155页

作者： Jiaojiao Lu Qiongqun Pan Jieqiang Zhou Yan Weng Kaili Chen Lv Shi Guanxiu Zhu Chunlin Chen Liang Li Meiyu Geng Zhenqing Zhang Jiangsu Key Laboratory of Translational Research and Therapy for Neuro-Psycho-Diseases College of Pharmaceutical SciencesSoochow UniversitySuzhouJiangsu215021China Shanghai Green Valley Pharma.Corp. Shanghai201203China Medicilon Preclinical Research(Shanghai)LLC Shanghai201299China State Key Laboratory of Drug Research Shanghai Institute of Materia MedicaChinese Academy of SciencesShanghai201203China

The National Medical Products Administration has authorized sodium oligomannate for treating mild-to-moderate Alzheimer’s *** this study,an LC-MS/MS method was developed and validated to quantitate sodium oligomannate in different *** plasma pharmacokinetics,tissue distribution,and excretion of sodium oligomannate in Sprague-Dawley rats and beagle dogs were systematically *** its complicated structural composition,the absorption,distribution,metabolism,and excretion profiles of the oligosaccharides in sodium oligomannate of different sizes and terminal derivatives were *** oligomannate mainly crossed the gastrointestinal epithelium through paracellular transport following oral administration,with very low oral bioavailability in rats(0.6%-1.6%)and dogs(4.5%-9.3%).Absorbed sodium oligomannate mainly resided in circulating body fluids in free form with minimal distribution into erythrocytes and major *** oligomannate could penetrate the blood-cerebrospinal fluid(CSF)barrier of rats,showing a constant area under the concentration-time curve ratio(CSF/plasma)of approximately 5%.The cumulative urinary excretion of sodium oligomannate was commensurate with its oral bioavailability,supporting that excretion was predominantly renal,whereas no obvious biliary secretion was observed following a single oral dose to bile duct-cannulated ***,only 33.7%(male)and 26.3%(female)of the oral dose were recovered in the rat excreta within 96 h following a single oral administration,suggesting that the intestinal flora may have ingested a portion of unabsorbed sodium oligomannate as a nutrient.

关键词： Sodium oligomannate Alzheimer’s disease pharmacokinetics LC-MS/MS Oligosaccharide

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pharmacokinetics of Enrofloxacin and Its Metabolite in Carp (Cyprinus carpio) After a Single Oral Administration in Medicated Feed

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Journal of Ocean University of China 2023年第1期22卷 171-180页

作者： LIU Ying LI Zhaoxin ZHANG Dahai XING Lihong SUN Weihong SUN Xiaojie PENG Jixing ZHANG Yonggang LI Xianguo College of Chemistry and Chemical Engineering Ocean University of ChinaQingdao 266100China Qingdao Fishery Technology Service Station Qingdao 266071China Qingdao Marine Management Support Center Qingdao 266071China Key Laboratory of Testing and Evaluation for Aquatic Product Safety and Quality Laboratory of Quality&Safety Risk Assessment for Aquatic ProductsMinistry of Agriculture and Rural AffairsYellow Sea Fisheries Research InstituteChinese Academy of Fishery SciencesQingdao 266071China

A precise and reliable analytical method of high performance liquid chromatography-tandem mass spectrometry(HPLCMS/MS)was developed to measure trace levels of enrofloxacin(ENR)and its major metabolite ciprofloxacin(CIP)in carp *** chromatographic separation was obtained on a Waters Xterra MS C_(18) reversed-phase column using gradient elution with methanol and 0.1%formic acid aqueous solution including 5mmolL^(-1) of ammonium *** established method was applied to study the pharmacokinetics and distribution of ENR and CIP in tissues of carp following a single oral administration in feed at a dosage of 40mgkg^(-1) bw(body weight).Data were analyzed using DAS 2.0 dynamics software,and the experimental results suggest that ENR was rapidly absorbed and extensively distributed in carp tissues through systemic circulation,and the pharmacokinetic characteristics can be described with a two-compartment *** elimination half-lives(t_(1/2β))from muscle,liver,gill,plasma and skin were 131,160,104,132 and 310 h,*** areas under the drug concentration-time curves(AUC)for these tissues were 491,972,750,249 and 706hmgkg^(-1),*** maximum concentration(C_(max))values were 13,29,37,9 and 5mgkg^(-1) with peak times(t_(max))of 8,4,4,2 and 4 h,***,the active metabolite of ENR,was also detected in carp tissues,indicating that only 1.54%of de-ethylation of ENR occurs in *** a water temperature of 18℃,the drug withdrawal time was determined to be no less than 24 d while the carp was fed at a single dosage of 40mgkg^(-1).

关键词： Cyprinus carpio enrofloxacin ciprofloxacin pharmacokinetics liquid chromatography-tandem mass spectrometry

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Recent advances in the translation of drug metabolism and pharmacokinetics science for drug discovery and development

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Acta Pharmaceutica Sinica B 2022年第6期12卷 2751-2777页

作者： Yurong Lai Xiaoyan Chu Li Di Wei Gao Yingying Guo Xingrong Liu Chuang Lu Jialin Mao Hong Shen Huaping Tang Cindy Q.Xia Lei Zhang Xinxin Ding Drug Metabolism Gilead Sciences Inc.Foster CityCA 94404USA Department of pharmacokinetics Pharmacodynamics and Drug MetabolismMerck&Co.Inc.KenilworthNJ 07033USA pharmacokinetics Dynamics and MetabolismPﬁzer Worldwide Research and DevelopmentGrotonCT 06340USA Eli Lilly and Company IndianapolisIN 46221USA Drug Metabolism and pharmacokinetics BiogenCambridgeMA 02142USA Drug Metabolism and pharmacokinetics Accent TherapeuticsInc.LexingtonMA 02421USA Department of Drug Metabolism and pharmacokinetics GenentechA Member of the Roche GroupSouth San FranciscoCA 94080USA Drug Metabolism and pharmacokinetics Department Bristol-Myers Squibb CompanyPrincetonNJ 08540USA Bioanalysis and Biomarkers Glaxo Smith KlineKing of the PrussiaPA 19406USA Department of Drug Metabolism and pharmacokinetics Takeda Pharmaceuticals International Co.CambridgeMA 02139USA Ofﬁce of Research and Standards Ofﬁce of Generic DrugsCDERFDASilver SpringMD 20993USA Department of Pharmacology and Toxicology College of PharmacyUniversity of ArizonaTucsonAZ 85721USA Current afﬁliation:Translational Medicine EMD Serono Research&Development InstituteInc.BillericaMA 01821USA Current afﬁliation:Drug Metabolism Gilead Sciences Inc.Foster CityCA 94404USA

Drug metabolism and pharmacokinetics(DMPK) is an important branch of pharmaceutical *** nature of ADME(absorption,distribution,metabolism,excretion) and PK(pharmacokinetics) inquiries during drug discovery and development has evolved in recent years from being largely descriptive to seeking a more quantitative and mechanistic understanding of the fate of drug candidates in biological *** progress has been made in the past decade,not only in the characterization of physiochemical properties of drugs that influence their ADME,target organ exposure,and toxicity,but also in the identification of design principles that can minimize drug-drug interaction(DDI) potentials and reduce the *** importance of membrane transporters in drug disposition,efficacy,and safety,as well as the interplay with metabolic processes,has been increasingly *** increases in investments on new modalities beyond traditional small and large molecule drugs,such as peptides,oligonucleotides,and antibody-drug conjugates,necessitated further innovations in bioanalytical and experimental tools for the characterization of their ADME *** this review,we highlight some of the most notable advances in the last decade,and provide future perspectives on potential major breakthroughs and innovations in the translation of DMPK science in various stages of drug discovery and development.

关键词： Drug discovery and development New drug application Biologics license application pharmacokinetics ADME New modalities Model-informed drug development Micro-physiological systems

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Predicting disruptions to drug pharmacokinetics and the risk of adverse drug reactions in nonalcoholic steatohepatitis patients

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Acta Pharmaceutica Sinica B 2023年第1期13卷 1-28页

作者： Solène Marie Kayla L.Frost Raymond K.Hau Lucy Martinez-Guerrero Jailyn M.Izu Cassandra M.Myers Stephen H.Wright Nathan J.Cherrington College of Pharmacy Department of Pharmacology&ToxicologyUniversity of ArizonaTucsonAZ 85721USA College of Medicine Department of PhysiologyUniversity of ArizonaTucsonAZ 85724USA

The liver plays a central role in the pharmacokinetics of drugs through drug metabolizing enzymes and ***-alcoholic steatohepatitis(NASH)causes disease-specific alterations to the absorption,distribution,metabolism,and excretion(ADME)processes,including a decrease in protein expression of basolateral uptake transporters,an increase in efflux transporters,and modifications to enzyme *** can result in increased drug exposure and adverse drug reactions(ADRs).Our goal was to predict drugs that pose increased risks for ADRs in NASH *** research identified 71 drugs with reported ADRs in patients with liver disease,mainly non-alcoholic fatty liver disease(NAFLD),54 of which are known substrates of transporters and/or metabolizing *** NASH is the progressive form of NAFLD but is most frequently undiagnosed,we identified other drugs at risk based on NASH-specific alterations to ADME ***,we present another list of 71 drugs at risk of pharmacokinetic disruption in NASH,based on their transport and/or metabolism *** encompasses drugs from various pharmacological classes for which ADRs may occur when used in NASH patients,especially when eliminated through multiple pathways altered by the ***,these results may inform clinicians regarding the selection of drugs for use in NASH patients.

关键词： Non-alcoholic steatohepatitis Hepatic elimination Transporter Enzyme pharmacokinetics Drug-drug interaction Liver Adverse drug reaction

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Eight Zhes Decoction ameliorates the lipid dysfunction of nonalcoholic fatty liver disease using integrated lipidomics, network pharmacology and pharmacokinetics

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Journal of Pharmaceutical Analysis 2023年第9期13卷 1058-1069页

作者： Yuping Zhou Ze Dai Kaili Deng Yubin Wang Jiamin Ying Donghui Chu Jinyue Zhou Chunlan Tang The First Affiliated Hospital of Ningbo University NingboZhejiang315020China School of Public Health Health Science CenterNingbo UniversityNingboZhejiang315211China Institute of Digestive Disease of Ningbo University NingboZhejiang315020China

Nonalcoholic fatty liver disease(NAFLD)has developed into the most common chronic liver disease and can lead to liver *** laboratory previously developed a novel prescription for NAFLD,“Eight Zhes Decoction”(EZD),which has shown good curative effects in clinical ***,the pharmacodynamic material basis and mechanism have not yet been revealed.A strategy integrating lipidomics,network pharmacology and pharmacokinetics was used to reveal the active components and mechanisms of EZD against *** histopathological results showed that EZD attenuated the degrees of collagen deposition and steatosis in the livers of nonalcoholic steatofibrosis model ***,glycerophospholipid metabolism,arachidonic acid metabolism,glycerolipid metabolism and linoleic acid metabolism with phospholipase A2 group IVA(PLA2G4A)and cytochrome P450 as the core targets and 12,13-cis-epoxyoctadecenoic acid,12(S)-hydroxyeicosatetraenoic acid,leukotriene B4,prostaglandin E2,phosphatidylcholines(PCs)and triacylglycerols(TGs)as the main lipids were found to be involved in the treatment of NAFLD by ***,naringenin,artemetin,canadine,and bicuculline were identified as the active ingredients of EZD against NAFLD;in particular,naringenin reduces PC consumption by inhibiting the expression of PLA2G4A and thus promotes sufficient synthesis of very-low-density lipoprotein to transport excess TGs in the *** research provides valuable data and theoretical support for the application of EZD against NAFLD.

关键词： Eight Zhes Decoction Nonalcoholic fatty liver disease Lipidomics Network pharmacology pharmacokinetics

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