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Biological fate and interaction with cytochromes P450 of the nanocarrier material,D-α-tocopheryl polyethylene glycol 1000 succinate

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Acta Pharmaceutica Sinica B 2022年第7期12卷 3156-3166页

作者： Tianming Ren Runzhi Li Liqiang Zhao j.Paul fawcett Dong Sun jingkai Gu Research Center for Drug Metabolism School of Life SciencesJilin UniversityChangchun 130012China State Key Laboratory of Supramolecular Structure and Materials Jilin UniversityChangchun 130012China Beijing Institute of Drug Metabolism Beijing 102209China

D-a-Tocopheryl polyethylene glycol 1000 succinate(TPGS,also known as vitamin E-TPGS)is a biodegradable amphiphilic polymer prepared by esterification of vitamin E with polyethylene glycol(PEG)*** is approved by the US Food and Drug Administration(FDA)and has found wide application in nanocarrier drug delivery systems(NDDS).Fully characterizing the in vivo fate and pharmacokinetic behavior of TPGS is important to promote the further development of TPGS-based ***,to date,a bioassay for the simultaneous quantitation of TPGS and its metabolite,PEG1000,has not been *** the present study,we developed such an innovative bioassay and used it to investigate the pharmacokinetics,tissue distribution and excretion of TPGS and PEG1000 in rat after oral and intravenous *** addition,we evaluated the interaction of TPGS with cytochromes P450(CYP450s)in human liver *** results show that TPGS is poorly absorbed after oral administration with very low bioavailability and that,after intravenous administration,TPGS and PEG1000 are mainly distributed to the spleen,liver,lung and kidney before both being slowly eliminated in urine and feces as *** vitro studies show the inhibition of human CYP450 enzymes by TPGS is limited to a weak inhibition of ***,our results provide a clear picture of the in vivo fate of TPGS which will be useful in evaluating the safety of TPGS-based NDDS in clinical use and in promoting their further development.

关键词： TPGS LC-MS/MS Nanocarrier materials Pharmacokinetics Tissue distribution Metabolism Excretion Cytochrome P450

Separation and simultaneous quantitation of PGF2α and its epimer 8-iso-PGF2α using modifier-assisted differential mobility spectrometry tandem mass spectrometry

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Acta Pharmaceutica Sinica B 2018年第2期8卷 228-234页

作者： Chunsu Liang Hui Sun Xiangjun Meng Lei Yina j.Paul fawcett Huaidong Yu Ting Liu jingkai Gu Research Center for Drug Metabolism School of Life Sciences Jilin University School of Pharmacy University of Otago Shanghai AB Sciex Analytical Instrument Trading Co. Ltd.

Because many therapeutic agents are contaminated by epimeric impurities or form epimers as a result of metabolism, analytical tools capable of determining epimers are increasingly in demand. This article is a proof-of-principle report of a novel DMS–MS/MS method to separate and simultaneously quantify epimers, taking PGF2α and its 8-epimer, 8-iso-PGF2α, as an example. Good accuracy and precision were achieved in the range of 10–500 ng/m L with a run time of only 1.5 min. Isopropanol as organic modifier facilitated a good combination of sensitivity and separation. The method is the first example of the quantitation of epimers without chromatographic separation.

关键词： Differential mobility spectrometry Mass spectrometry Epimer PGF2α 8-iso-PGF2α

Ampullary cancer of intestinal origin and duodenal cancer-A logical clinical and therapeutic subgroup in periampullary cancer

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World journal of Gastrointestinal Oncology 2017年第10期9卷 407-415页

作者： Manju D Chandrasegaram Anthony j Gill jas Samra Tim Price john Chen jonathan fawcett Neil D Merrett the Prince Charles Hospital School of Medicine University of Queensland Sydney Medical School University of Sydney Cancer Diagnosis and Pathology Group Kolling Institute of Medical Research Royal North Shore Hospital Department of Surgery Royal North Shore Hospital Queen Elizabeth Hospital University of Adelaide Flinders Medical Centre Royal Adelaide Hospital Princess Alexandra Hospital Department of Upper GI Surgery Bankstown Hospital Discipline of Surgery Western Sydney University

Periampullary cancers include pancreatic, ampullary, biliary and duodenal cancers. At presentation, the majority of periampullary tumours have grown to involve the pancreas, bile duct, ampulla and duodenum. This can result in difficulty in defining the primary site of origin in all but the smallest tumors due to anatomical proximity and architectural distortion. This has led to variation in the reported proportions of resected periampullary cancers. Pancreatic cancer is the most common cancer resected with a pancreaticoduodenectomy followed by ampullary(16%-50%), bile duct(5%-39%), and duodenal cancer(3%-17%). Patients with resected duodenal and ampullary cancers have a better reported median survival(29-47 mo and 22-54 mo) compared to pancreatic cancer(13-19 mo). The poorer survival with pancreatic cancer relates to differences in tumour characteristics such as a higher incidence of nodal, neural and vascular invasion. While small ampullary cancers can present early with biliary obstruction, pancreatic cancers need to reach a certain size before biliary obstruction ensues. This larger size at presentation contributes to a higher incidence of resection margin involvement in pancreatic cancer. Ampullary cancers can be subdivided into intestinal or pancreatobiliary subtype cancers with histomolecular staining. This avoids relying on histomorphology alone, as even some poorly differentiated cancers preserve the histomolecular profile of their mucosa of origin. Histomolecular profiling is superior to anatomic location in prognosticating survival. Ampullary cancers of intestinal subtype and duodenal cancers are similar in their intestinal origin and form a logical clinical and therapeutic subgroup of periampullary cancers. They respond to 5-FU based chemotherapeutic regimens such as capecitabine-oxaliplatin. Unlike pancreatic cancers, KRAS mutation occurs in only approximately a third of ampullary and duodenal cancers. Future clinical trials should group ampullary cancer

关键词： Periampullary cancer Pancreatobiliary subtype Intestinal subtype Ampullary cancer Duodenal cancer Epidermal growth factor receptor Pancreatic cancer Chemotherapy Pancreaticoduodenectomy KRAS

液相色谱-电喷雾离子阱质谱法分析SFZ-47在鸡胚体内代谢(英文)

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Acta Pharmacologica Sinica 2003年第6期24卷 98-102+144页

作者：董庆光,顾景凯,钟大放,j Paul fawcett,周慧吉林大学药物代谢研究中心吉林大学药物代谢研究中心沈阳药科大学药物代谢与动力学实验室 Otago大学药学系吉林大学药物代谢研究中心长春 130023 长春 130023 沈阳 110051 达尼丁新西兰长春 130023

目的:以3H-1,2-二氢-2-(4-甲基苯胺基)甲基-1-吡咯里嗪酮(SFZ-47)为探针药物探索用鸡胚研究药物代谢的新方法。方法:SFZ-47(15mg)注入孵化10天的受精鸡蛋的卵清中,继续孵化72h,取尿囊液以XAD-2树脂处理,然后用液相色谱-电喷雾离子阱质... 详细信息

目的:以3H-1,2-二氢-2-(4-甲基苯胺基)甲基-1-吡咯里嗪酮(SFZ-47)为探针药物探索用鸡胚研究药物代谢的新方法。方法:SFZ-47(15mg)注入孵化10天的受精鸡蛋的卵清中,继续孵化72h,取尿囊液以XAD-2树脂处理,然后用液相色谱-电喷雾离子阱质谱进行分析。结果:三个代谢产物被鉴定,即4-(3H-1,2-二氢-1-吡咯里嗪酮-2-甲基胺基)苯甲醇(SFZ-47-OH),4-(3H-1,2-二氢-1-吡咯里嗪酮-2-甲基胺基)苯甲酸(SFZ-47-COOH)及其酯型葡萄糖苷酸结合物。结论:鸡胚可以进行药物的Ⅰ相和Ⅱ相代谢反应,有望成为药物代谢研究的一种新模型。

关键词： SFZ-47 鸡胚代谢液相色谱法电喷雾离子质量光谱法

Rapid Determination of Ranitidine in Human Plasma by Liquid Chromatography-Tandem Mass Spectrometry and Its Application to a Clinical Pharmacokinetic Study

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Chemical Research in Chinese Universities 2010年第6期26卷 910-914页

作者： ZHANG Chao WANG Lu GUAN Xin j. Paul fawcett ZHAO Li-mei SUN Yan-tong GU jing-kai Research Center for Drug Metabolism College of Life Science Jilin University Changchun 130021 P R. China Liaoning Province Academy of Analytic Science Shenyang 110015 P. R. China School of Pharmacy University of Otago PO Box 56 Dunedin New Zealand Second Clinical Hospital Affiliated to the Chinese Medical University Shenyang 110004 P. R. China

A rapid and sensitive assay based on high performance liquid chromatography-tandem mass spectrometry（LC-MS/MS） was developed for the determination of ranitidine（RAN） in human plasma with codeine as internal standard（IS）.After protein precipitation with acetonitrile,the analyte and IS were separated on a Zorbax SB-Aq C18 column（150 mm×4.6 mm i.d.,5 μm） eluted with a mobile phase consisting of methanol/acetonitrile/10 mmol/L ammonium acetate containing 1% formic acid（pH=2.4）（volume ratio 12.5：12.5：75） at a flow rate of 1.0 mL/*** was performed by electrospray ionization in the positive ion mode followed by the multiple reaction monito-ring（MRM） of the transitions of RAN at m/z 315.1→176.3 and of IS at m/z 300.1→*** method was linear over a concentration range of 1―1000 ng/mL（r=0.9991） with a lower limit of quantitation（LLOQ） of 1 ng/mL and a limit of detection（LOD） of 0.3 ng/*** as relative error was from-0.01% to-1.7% and intra-day and inter-day precisions as relative standard deviation were ≤8.9% and ≤5.5%,*** method was successfully applied to a pharmacokinetic study of ranitidine,getting a single oral dose（160 mg） to healthy volunteers.

关键词： Ranitidine Pharmacokinetics Human plasma Protein precipitation LC-MS/MS

LC-MS/MS Method for the Quantitation of Cefotetan in Human Plasma and Its Application to Pharmacokinetic Study

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Chemical Research in Chinese Universities 2014年第6期30卷 900-904页

作者： SHI Meiyun YIN Lei CAI Lanlan WANG Can LIU Xidong ZHAO Sen SUN Yantong fawcett j. Paul ZHAO Limei YANG Yan GU jingkai College of Life Science Jilin University Changchun 130012 t~ R. China Clinical Pharmacology Center Research Institute of Translational Medicine the First Hospital of Jilin University Changchun 130061 1~ R. China" School of Pharmaceutical Sciences dilin University Changchun 130021 P. R. China School of Pharmacy University of Otago Dunedin 9054 New Zealand The Second Clinical Hospital Affiliated to Chinese Medical University Shenyang 110004 P. R. China

A rapid and sensitive liquid chromatography-tandem mass spectrometry（LC-MS/MS） method for the de- termination of cefotetan in human plasma was developed and validated. After the protein precipitation of sample with acetonitrile, the analyte and internal standard（IS）, tramadol, were separated on a Zorbax XDB C8 column using ace- tonitrile/1%（volume fraction） formic acid（volume ratio 35：65, pH=2.5） as mobile phase at a flow rate of 1.0 mL/min with a 1 ： 1 split. The detection was performed by electrospray ionization with positive ion mode, followed by multiple reaction monitoring of the transitions for cefotetan at m/z 576.3→460.2（quantifier） and m/z 576.3→432.2（qualifier） and for IS at m/z 264.1→58.1. Cefotetan and IS were eluted at 1.86 and 1.87 rain, respectively. The assay was linear over the concentration range of 0.1-100 gg/mL for 20 μL of human plasma only with intra- and inter-day preci- sions（expressed as the relative standard deviation） of less than 6.62% and accuracies（as relative error） of ＋1.31%. The method was applied to the pharmacokinetic study of a l-h intravenous infusion of 1.0 g of cefotetan disodium for human volunteers（n=6）.

关键词： Cefotetan Liquid chromatography-tandem mass spectrometry(LC-MS/MS) Pharmacokinetics Humanplasma

Rapid Quantification of Astilbin in Rat Plasma by Liquid Chromatography-tandem Mass Spectrometry and Its Application to Pharmacokinetic Study

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Chemical Research in Chinese Universities 2013年第6期29卷 1078-1082页

作者： YIN Lei ZHANG Yun-hui ZHAO Sen CHENG Long-mei SHI Mei-yun YANG Yan SUN Yan-tong LIU Xi-dong fawcett j. Paul School of Life Sciences Jilin University Changchun 130012 P.R.China Clinical Pharmacology Center Research Institute of Translational Medicine the First Hospital of Jilin University Changchun 130061 P.R.China National Engineering Laboratory for AIDS Vaccine the Ministry of EducationJilin University Changchun 130012 P.R.China Key Laboratory for Molecular Enzymology and Engineering the Ministry of EducationJilin University Changchun 130012 P.R.China School of Pharmaceutical Sciences Jilin University Changchun 130021 P. R. China School of Pharmacy University of Otago Dunedin 9054 New Zealand

Astilbin is a potential immunosuppressive agent with minor cytotoxicity. Its oral bioavailability is supposed to be rather low and therefore a sensitive analytical method is required for its pharmacokinetic study after oral administration. A simple, sensitive and rapid liquid chromatography-tandem mass spectrometry（LC-MS/MS） method was developed and validated for the determination of astilbin in rat plasma. Plasma samples were subjected to liquid-liquid extraction with ethyl acetate and separated by reversed phase high performance liquid chromatography（HPLC） with methanol-0.01%（volume fraction） formic acid（50：50, volume ratio） as mobile phase. Quantitive determination was achieved on negative LC-MS/MS by a multiple reaction moitoring method with transitions m/z 449.1→150.9（quantifier） and m/z 449.1→284.9（qualifier） for astilbin and m/z 128.9→42.0 for internal standard（IS）. A lower limit of quantification（LLOQ） of ng/mL was achieved within a short cycle time of 3.4 min. The method was successfully applied to a pharmacokinetic study involving oral and intravenous administrations of 6 mg/kg astilbin to six rats.

关键词： Astilbin Liquid chromatography-tandem mass spectrometry(LC-MS/MS) Pharmacokinetics Rat Plasma

Helicobacter pylori serology in a birth cohort of New Zealanders from age 11 to 26

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World journal of Gastroenterology 2005年第21期11卷 3273-3276页

作者： j.Paul fawcett Gill O.Barbezat Richie Poulton Barry j.Milne Harry H.X.Xia Nicholas j.Talley School of Pharmacy University of Otago DunedinNew Zealand Dunedin School of Medicine University of Otago DunedinNew Zealand Dunedin Multidisciplinary Health and Development Research Unit Dunedin School of Medicine University of Otago Dunedin New Zealand Department of Medicine The University of Hong Kong Queen Mary Hospital Hong Kong China Department of Medicine The University of Sydney Nepean HospitalNSW 2751Australia

AIM: To determine seroprevalence of Helicobacter pylori (Hpylori)in the Dunedin Multidisciplinary Health and Development Study (DMHDS) at age 26 in order to investigate seroconversion and seroreversion from age 11 to 26 and the association of seropositivity with risk factors for H pylori infection. METHODS: Participants in the DMHDS at age 26 and retrospectively at age 21 were tested for H pylori antibodies using two commercially available ELISA ***, socioeconomic status (SES), smoking,educational attainment and employment at age 26 were tested for association with H pylori seropositivity. RESULTS: At ages 21 and 26,seroprevalence of H pylori using one or other kit was 4.2% (n=795) and 6.3% (n=871) respectively, Seroreversion rate was lower than seroconversion rate (0.11% vs 0.53% per person-year) in contrast to the period from age 11 to 21 when seroreversion rate exceeded seroconversion rate (0.35% vs 0.11% per person-year). Serology in those tested at ages 11, 21, and 26 remained unchanged in 93.6% of the sample. Seroprevalence at age 26 was lower among those with a secondary school qualification (P=0.042) but was not associated with gender, SES, smoking or employment status. CONCLUSION: H pylori seroprevalence in a New Zealand birth cohort remains low between ages 11 and 26. H pylori infection remains stable from childhood to adulthood although seroreversion seems to be more common in the adolescent years than in young adults.

关键词： H pylori Seroprevalence Cohort

Quantitation of bivalirudin,a novel anticoagulant peptide,in human plasma by LC-MS/MS:Method development,validation and application to pharmacokinetics

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journal of Pharmaceutical Analysis 2013年第1期3卷 1-8页

作者： Xiao-jiao Li Yan-Tong Sun Lei Yin Xue-ju Zhang Yan Yang j.Paul fawcett Yi-Min Cui jing-Kai Gu Clinical Pharmacology Center Research Institute of Translational MedicineThe First Bethune Hospital of Jilin University Research Center for Drug Metabolism College of Life ScienceJilin University School of Pharmacy University of Otago Department of Pharmacy Peking University First Hospital

A rapid and sensitive method based on liquid chromatographtandem mass spectrometry （LC-MS/MS） for the determination of a novel anticoagulant peptide bivalirudin in human plasma has been developed and validated. Plasma samples were precipitated protein with acetonitrile and reextracted with dichloromethane, after which the analyte and triptorelin as an internal standard （IS） were separated on a 300SB-Cl8 column （150 mm x 4.6 mm i.d., 5 gm particle size） using 0.1% formic acid：methanol （45：55, v/v） as mobile phase. The triple-quadrupole mass spectrometer, equipped with electrospray ionization （ESI） interface, was operated in the positive ion mode, and the multiplereaction monitoring （MRM） transitions of bivalirudin and IS were at m/z 1091.0-650.4 and m/z656.5 - 249.3, respectively. The lower limit of quantification （LLOQ） was 1 ng/mL for 100 ng/mL plasma sample and the assay was linear over the concentration range 1 1000 ng/mL. The accuracy was within a range from -0.4% to 0.5% in terms of relative error （RE） and the intra- and inter-day precisions in terms of relative standard deviation （RSD） were 〈2.92 and 〈 3.36, respectively. The method was successfully applied to a pharmacokinetic study involving intravenous administration of bivalirudin （0.5 mg/kg） to Chinese volunteers.

关键词： Bivalirudin LC-MS/MS Pharmacokinetics Human plasma Anticoagulant