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Science China Chemistry 2010年第11期53卷 2379-2386页

作者： FENG ChengLian,XU YiPing,ZHA JinMiao,LUO Qian,SHAN XiaoQuan & WANG ZiJian State Key Laboratory of Environmental Aquatic Chemistry Research Center for Eco-Environmental Sciences,Chinese Academy of Sciences,Beijing 100085,China State Key Laboratory of Environmental Aquatic Chemistry Research Center for Eco-Environmental Sciences Chinese Academy of Sciences Beijing China

Decabromodiphenyl ether(BDE209) is poorly absorbed by mammals,and little information is available on the toxicokinetics of BDE209 and its metabolites in *** the present study,rainbow trout(Oncorhynchus mykiss) were administered to 100 ng/g and 500 ng/g body wet weight of BDE209 via a single intraperitoneal injection and parent BDE209 and its metabolites were sequentially monitored for 28 *** results showed that toxicokinetic profiles of BDE209 could be described by the one-compartment *** the higher dose group(500 ng/g wet weight),the calculated half-life(t1/2) and elimination rate(ke) were 17.7 d and 0.039/d in the liver,and 100.3 d and 0.007/d in the muscle,*** major methoxylated brominated diphenyl ethers(MeO-BDEs) were detected with 2,2',4,4'-tetrabromo-5-methoxydiphenyl ether(5-MeO-BDE47) being detected in all tissue *** was no significant temporal change of 5-MeO-BDE47 concentration in the muscle,whereas an exponential increase was observed in the ***,the metabolism rate of BDE209 depended on the administered ***209 was hardly accumulated in the muscle of rainbow trout,while the liver was a primary metabolic ***-BDEs were formed via metabolism of BDE209,which probably played a significant role in fish toxicology as a potential indicator.

关键词： decabromodiphenyl ether(BDE209) polybrominated diphenyl ethers(PBDEs) methoxylated brominated diphenyl ethers(MeO-BDEs) toxicokinetics rainbow trout

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Effects of nanoscale quantum dots in male Chinese loaches (Misgurnus anguillicaudatus):Estrogenic interference action,toxicokinetics and oxidative stress

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Science China Chemistry 2009年第10期52卷 1683-1690页

作者： HongCheng Li WenRu Luo Yong Tao Yuan Wu XueFei Lv QunFang Zhou GuiBin Jiang State Key Laboratory of Environmental Chemistry and Ecotoxicology Research Center for Eco-Environmental Sciences Chinese Academy of Sciences Beijing 100085 China

Quantum dots (QDs) have more and more attention as a novel example of nanocrystals due to their unique fluorescent characteristics. Recently, the toxicity and the potential environmental effects of QDs have become a research hotspot. In this work, in vivo endocrine disrupting effect, toxicokinetics and oxidative stress of QDs were characterized following the intraperitoneal dosing in Chinese loaches. Vitellogenin (Vtg) levels induced by E2 decreased significantly when administrated with the mixture of QDs and E2, which was consistent with the observations of histopathology in testes. The release of free Cd2+ from QDs and the non-specific adsorption of E2 by QDs might be the joint factors contributing to the inhibition of Vtg expression induced by E2 in the male Chinese loaches. In the muscle, bone, intestines, blood and testis, CdSe QDs reached the maximal concentration (C max) in approximately 1-h postinjection and subsequently presented downtrend with the prolonged time. Whereas, there were even increasing tendencies of CdSe QDs’ concentrations in the liver and kidney. It is educible that CdSe QDs can be persistent at least for 7 days, indicating the overall half-life of CdSe QDs in the fish body is very long. The measurement of hepatic superoxide dismutase (SOD) activity and reduced glutathione (GSH) content indicate that QDs have smaller effects on the antioxidative system of the organisms compared with free Cd2+ due to the effective prevention of the release of Cd by PEG coating of QDs. The comprehensive evaluation of QDs’ toxicity in the present study provides an essential and general framework towards more focused research on the elucidation of the biological effects of QDs in vivo.

关键词： quantum dot estrogenic effect toxicokinetics oxidative stress

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toxicokinetics of A-1 in Beagle dog

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中国药理学与毒理学杂志 2013年第3期 531-532页

作者： LIAO Sha ZHANG Zhen-qing Beijing Institute of Pharmacology and Toxicology

OBJECTIVE To study toxicokinetics of A-1 at the three doses adopted in toxicology research,and explore the relationship between exposure level and toxicity in order to provide information to safety evaluation and toxicity *** Samples were analyzed with a validated LC-MS /MS *** the 28 day repeated dose study,A-1 dosages were 125,40 and 12.5 mg·*** day 1,blood samples were collected at 0.5,1,2,4,8,12,24 h after *** day 28,blood samples were collected at the same time *** concentration at different time points were determined after continuous oral administration at the dose of 125,40 and 12.5 mg·kg-1 once daily for 28 *** of concentration-time were fitted and toxicokinetics parameters were calculated by DAS *** In the repeated dose study,3 of 6 dogs were died in the 125 mg·kg-1.d-1 *** day 1,the A-1 AUC0-24 for doses 125,40 and 12.5 mg·kg-1 were(12115 ± 6905),(4856 ± 2025) and(539 ± 41) μg.h-1.L-1,*** were(6018 ± 3295),(2544 ± 1520) and(188 ± 106) μg·L-1,*** day 28,the A-1 AUC0-24 were(9179 ± 7407),(4977 ± 2691) and(557 ± 274) μg.h.L-1,*** were(3251 ± 3462),(2662 ± 1501) and(289 ± 211) μg·L-1,*** No significant sex difference was *** response to A-1 generally increased with increasing dosage in Beagle dogs following oral *** accumulation was observed after A-1 oral administration once daily for 28 d.

关键词： A-1 toxicokinetics Beagle dog LC-MS /MS

Tumor-targeting intravenous lipid emulsion of paclitaxel:Characteristics,stability,toxicity,and toxicokinetics

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Journal of Pharmaceutical Analysis 2022年第6期12卷 901-912页

作者： Jun Ye Lin Li Jiye Yin Hongliang Wang Renjie Li Yanfang Yang Yongbiao Guan Xuejun Xia Yuling Liu State Key Laboratory of Bioactive Substance and Function of Natural Medicines Institute of Materia MedicaChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing100050China Beijing Key Laboratory of Drug Delivery Technology and Novel Formulation Institute of Materia MedicaChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing100050China National Beijing Center for Drug Safety Evaluation and Research Beijing Institute of Pharmacology and ToxicologyAcademy of Military Medical SciencesBeijing100850China

Lipid nanoemulsions are promising nanodrug delivery carriers that can improve the efficacy and safety of paclitaxel(PTX).However,no intravenous lipid emulsion of PTX has been approved for clinical treatment,and systemic safety profiles have not yet been *** we outline the development of a PTXloaded tumor-targeting intravenous lipid emulsion(PTX Emul)and describe its characteristics,colloidal stability,and systemic safety profiles in terms of acute toxicity,long-term toxicity,and *** also compare PTX Emul with conventional PTX *** showed that PTX Emul exhibited an ideal average particle size(approximately 160 nm)with narrow size distribution and robust colloidal stability under different *** reaction and hemolysis tests revealed that PTX Emul did not induce hypersensitivity reactions and had no hemolytic *** addition,where the alleviated systemic toxicity of PTX Emul may be attributed to the altered toxicokinetic characteristics in beagle dogs,including the decreased AUC and increased plasma clearance and volume of distribution,PTX Emul alleviated acute and long-term toxicity as evidenced by the enhanced the median lethal dose and approximate lethal dose,moderate body weight change,decreased bone marrow suppression and organ toxicity compared with those under PTX injection at the same dose.A fundamental understanding of the systemic safety profiles,high tumor-targeting efficiency,and superior antitumor activity in vivo of PTX Emul can provide powerful evidence of its therapeutic potential as a future treatment for breast cancer.

关键词： Nanodrug delivery systems Lipid emulsion Paclitaxel Colloidal Stability toxicokinetics

toxicokinetics of A-1 in Beagle dog

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Toxicokinetics of A-1 in Beagle dog

Acute Toxicity and toxicokinetics of Tongguan Powder in Rats

2013年（第三届）中国药物毒理学年会暨药物非临床安全性评价研究论坛

作者： LIAO Sha ZHANG Zhen-qing Beijing Institute of Pharmacology and Toxicology

OBJECTIVE To study toxicokinetics of A-1 at the three doses adopted in toxicology research,and explore the relationship between exposure level and toxicity in order to provide information to safety evaluation and toxicity *** Samples were analyzed with a validated LC-MS/MS *** the 28 day repeated dose study,A-1 dosages were 125,40 and 12.5 mg·*** day 1,blood samples were collected at 0.5,1,2,4,8,12, 24 h after *** day 28,blood samples were collected at the same time *** concentration at different time points were determined after continuous oral administration at the dose of 125,40 and 12.5 mg·kg once daily for 28 *** of concentration-time were fitted and toxicokinetics parameters were calculated by DAS software. RESULTS In the repeated dose study,3 of 6 dogs were died in the 125 mg·kg·d *** day 1,the A-1 AUC for doses 125,40 and 12.5 mg·kg were(12115±6905),(4856±2025) and(539±41 )μg·h·L,respectively. cwere(6018±3295),(2544±1520) and(188±106)μg·L,*** day 28,the A-1 AUC were(9179±7407),(4977±2691) and(557±274)μg·h·L,respectively.c were(3251±3462),(2662±1501) and(289±211 )μg·L,*** No significant sex difference was *** response to A-1 generally Increased with Increasing dosage in Beagle dogs following oral *** accumulation was observed after A-1 oral administration once daily for 28 d.

关键词： A-1 toxicokinetics Beagle dog LC-MS/MS

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Medicinal Plant 2020年第6期11卷 94-97,103页

作者： Qun FENG Xin LI Min XIAO Tao ZHAO Xianzhen WANG Fanbo JING Jingchun YAO Lunan Pharmaceutical Group Co. Ltd. State Key Laboratory of Generic Manufacture Technology of Chinese Traditional Medicine Linyi 276006 China Affiliated Hospital of Qingdao University Qingdao 266100 China

[Objectives]To evaluate the acute toxicity and toxicokinetics of Tongguan Powder in rats,and provide references for clinical safe medication.[Methods]The classical acute toxicity test method was used,rats were given different doses of Tongguan Powder through the mouth and nasal cavity to observe the symptoms of toxicity,and make a record of the food intake,weight changes,and *** the medication,blood was taken from each group of rats at different time points,and the plasma levels of benzoyl aconitine(BA),benzoyl hypaconine(BH)and benzoyl mesaconine(BM)were determined by the liquid chromatography tandem-mass spectrometry(LC-MS/MS),and the toxicokinetic parameters were fitted with the aid of DAS software.[Results]Rats were given Tongguan Powder 3.75 g/kg(equivalent to 54 times the human daily dose)in the nasal cavity of *** were observed with reactions such as scratching and sneezing;rats were given Tongguan Powder LD50 and 95%confidence limit of 4.15(3.53-4.71)g/kg through the oral administration,which is equivalent to 60 times the human daily dose,rats showed slow weight gain,decreased food intake,decreased voluntary activities,prone,black stools,*** hour after nasal administration of Tongguan Powder,the plasma concentration of benzoyl aconitine and benzoyl hypaconine was below the lower limit of detection,and benzoyl mesaconine could not be detected at any time point;one hour after the oral administration of Tongguan Powder,the plasma concentration of the three components reached the maximum,the exposure level of benzoyl hypaconine was higher than that of benzoyl aconitine and benzoyl mesaconine;there was no gender difference in the kinetic parameters.[Conclusions]The toxicity of Tongguan Powder in nasal administration is much lower than that of intragastric *** target organs and mechanism of toxicity need to be further studied.

关键词： Tongguan Powder Aconitine Acute toxicity toxicokinetics

INFLUENCE OF ETHANOL ON toxicokinetics OF ACONITINE

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Journal of Pharmaceutical Analysis 1994年第1期8卷 52-55,76页

作者：徐威胡炳蔚车向明

A reverse-phase High-performance Liquid Chromatography (HPLC) method for the detection of aconitine (AC) in biological samples was used. After orally ingested Aconitum brochypodum Diels (AbD) to rabbits, the toxicokinetics process of AC showed a two-compartment open ***. A and B of which were 1.1629±0. 4053, 0. 6046±0.2574 and 1. 1607±0. 3781 mg/L respectively. The influence of ethanol on this kinetics process was studied. It was indicated that ethanol did not change the model type, but the absorption and distribution of which were improved significantly (P<0. 01), its elimination process was not influenced significantly, the values of Ka. A and B were 2. 4026 ±0. 5376, 1. 205± 0. 5328, 1. 2037 ±0. 4095 mg/L respectively. All these suggest that ethanol increases the toxicity of AbD.

关键词： toxicokinetics interaction aconitine ethanol

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Evaluation of human monoclonal antibody toxicity,toxicokinetics and immunogenicity in cynomolgus monkeys after 4-week repeatⅣdose with 4-week recovery

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Evaluation of human monoclonal antibody toxicity,toxicokinet...

Gender differences of the hepatotoxicity and toxicokinetics of emodin:GWAS and RNA-Seq analysis reveal the role of UGT2B7 in the detoxification pathway

2013年（第三届）中国药物毒理学年会暨药物非临床安全性评价研究论坛

作者： YU Hong Patricia RYAN LIANG Mei-na ZHENG Wei-jun QIN Qiu-ping Dale THURMAN QIAO Jun-wen REN Jin Centre for Drug Safety Evaluation and Research Shanghai Institute of Materia Medica Global Safety Assessment AstraZeneca R&D Boston

OBJECTIVE The aim of this study was to characterize the toxicity of the antibody and in particular,the exposure-response relationship of the immune-mediated toxicity between these two dose *** 36 cynomolgus monkeys(6 monkeys/sex/group,3 groups) were given intravenous doses of the antibody at either 15 mg/kg QW or 30 mg·kg Q2W for 4 weeks followed by 4 weeks *** following were assessed for all animals:clinical observations (cage side observations,detailed clinical observations,physical examinations/clinical assessments and injection site observations),body weight,food consumption,ophthalmology,ECG,blood pressure haematology,coagulation, blood chemistry,urine analysis,levels of concentration of the antibody,toxicokinetics,immunogenicity(anti-drug antibody, ADA) in serum and gross and microscopic *** AND CONCLUSION The antibody caused histopathological changes in the liver and clinical pathological changes were seen including decreases in albumin/globulin ratios and in white blood cell ***,the changes in histopathology and clinical pathological parameters were all recovered at the end of the recovery *** monkeys given multiple intravenous doses of 15 mg·kg QW or 30 mg·kg Q2W of the antibody showed comparable serum exposures,assessed by AUC and the serum CL was similar between these two dose *** 16.7%of monkeys developed ADA while receiving 15 mg·kg QW antibody, whereas 25%of monkeys developed ADA after receiving 30 mg·kg *** ADA positive animals were female and the presence of ADA in these animals was associated with reduced TK *** the non adverse nature of the findings, both dose regimens,15 mg·kg QW and 30 mg·kg Q2W,were considered no-observed-adverse-effect levels.

关键词： monoclonal antibody toxicity toxicokinetics

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Gender differences of the hepatotoxicity and toxicokinetics ...

Evaluation of human monoclonal antibody toxicity,toxicokinetics and immunogenicity in cynomolgus monkeys after 4-week repeat IV dose with 4-week recovery

第三届全国药物代谢动力学青年科学家论坛暨刘昌孝人才奖颁奖大会

作者：唐斓南方医科大学药学院

Aim:Emodin(6-methyl-1,3,8-trihydroxyanthraquinone),a natural anthraquinone from Chinese traditional medicines including Polygonum multiflorum,Polygonum cuspidatum,and rhubarb,has obvious liver and kidney toxicity affected by its *** has been demonstrated that there is gender difference in emodin ***,we presume the gender differences in hepatotoxicity was associated to emodin *** aim of this study was to define the mechanisms of emodin detoxification,as well as the gender ***:Rats were orally administered varying doses(60 and 150 mg/kg/d) of emodin,once per day for 28 *** and biochemical tests were performed to assess the toxicity of emodin.A rapid and sensitive UPLC-MS/M S assay was developed for toxicokinetic analysis of emodin on day one and day 28 *** determine the most important UGTs responsible for detoxification,the effect of genetic variations and UDP-glucuronosyltransferases(UGTs) genes on emodin glucuronidation were investigated by integrating genomic and transcriptomic data from human liver and kidney tissues.55 liver samples and 36 kidney samples were collected for catalyzing *** variations and mRNA levels of these samples were detected by Illumina SNP chip and Hiseq 4000,*** cytotoxicity and enzyme kinetics of emodin in siUGT2 B7-HepG2 cells were clarified ***:After oral administration of emodin,evident hepatic injuries were observed in rats in both model group and emodin groups 28 days after treatment,and it was time-and *** toxicity were more severe in female than male *** obvious nephrotoxicity was *** absorbed emodin was rapidly and extensively converted into *** peaks occurred due to enterohepatic circulation after administrated with *** AUC and MRT of emodin displayed a significant increase in day 28 th compared to day one in both ***,the AUC of emodin in femal

关键词： Emodin Hepatotoxicity toxicokinetics UGT2B7 Detoxification

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中国药理学与毒理学杂志 2013年第3期 545-545页

OBJECTIVE The aim of this study was to characterize the toxicity of the antibody and in particular,the exposure-response relationship of the immune-mediated toxicity between these two dose *** 36 cynomolgus monkeys(6 monkeys /sex /group,3 groups) were given intravenous doses of the antibody at either 15 mg /kg QW or 30 mg·kg-1 Q2W for 4 weeks followed by 4 weeks *** following were assessed for all animals: clinical observations(cage side observations,detailed clinical observations,physical examinations /clinical assessments and injection site observations),body weight,food consumption,ophthalmology,ECG,blood pressure haematology,coagulation,blood chemistry,urine analysis,levels of concentration of the antibody,toxicokinetics,immunogenicity(anti-drug antibody,ADA) in serum and gross and microscopic *** AND CONCLUSION The antibody caused histopathological changes in the liver and clinical pathological changes were seen including decreases in albumin /globulin ratios and in white blood cell ***,the changes in histopathology and clinical pathological parameters were all recovered at the end of the recovery *** monkeys given multiple intravenous doses of 15 mg·kg-1 QW or 30 mg·kg-1 Q2W of the antibody showed comparable serum exposures,assessed by AUC and the serum CL was similar between these two dose *** 16.7% of monkeys developed ADA while receiving 15 mg·kg-1 QW antibody,whereas 25% of monkeys developed ADA after receiving 30 mg·kg-1 *** ADA positive animals were female and the presence of ADA in these animals was associated with reduced TK *** the non adverse nature of the findings,both dose regimens,15 mg·kg-1 QW and 30 mg·kg-1 Q2W,were considered no-observed-adverse-effect levels.

关键词： monoclonal antibody toxicity toxicokinetics