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Article ; Online: Development and validation of a ligand-binding assay for quantification of the F(ab')

Gui, Yuzhou / Yu, Chengyin / Zhou, Jiaye / Xin, Liang / Chen, Ze / Fan, Tiejiong / Lu, Shuang / Jia, Jingying / Liu, Gangyi

Journal of pharmaceutical and biomedical analysis

2022 Volume 212, Page(s) 114645

Abstract: Daboia russelii siamensis accounts for most of snakebite mortalities in China, yet, specific treatment against the venom toxins is absent in clinical practice. The F(ab') ...

Abstract	Daboia russelii siamensis accounts for most of snakebite mortalities in China, yet, specific treatment against the venom toxins is absent in clinical practice. The F(ab')
MeSH term(s)	Animals ; Antivenins/therapeutic use ; Humans ; Ligands ; Daboia ; Snake Bites/drug therapy ; Viper Venoms/therapeutic use
Chemical Substances	Antivenins ; Ligands ; Viper Venoms
Language	English
Publishing date	2022-02-04
Publishing country	England
Document type	Clinical Trial, Phase I ; Journal Article
ZDB-ID	604917-5
ISSN	1873-264X ; 0731-7085
ISSN (online)	1873-264X
ISSN	0731-7085
DOI	10.1016/j.jpba.2022.114645
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Article ; Online: Safety, tolerability, and pharmacokinetics of fluoropezil (DC20), a novel acetylcholinesterase inhibitor: A phase I study in healthy young and elderly Chinese subjects.

Qian, Hongjie / Yu, Chengyin / Zhu, Huijuan / Ding, Qichen / Cai, Yuting / Jing, Jiao / Xu, Xin / Guo, Runcong / Zhang, Haiyan / Liu, Hong / Chen, Xiaoyan / Liu, Yun

Clinical and translational science

2023 Volume 16, Issue 5, Page(s) 810–822

Abstract: The present study evaluated the safety, tolerability, and pharmacokinetics of fluoropezil (DC20), a novel acetylcholinesterase inhibitor under development for the treatment of Alzheimer's disease (AD) in otherwise healthy young and elderly Chinese ... ...

Abstract	The present study evaluated the safety, tolerability, and pharmacokinetics of fluoropezil (DC20), a novel acetylcholinesterase inhibitor under development for the treatment of Alzheimer's disease (AD) in otherwise healthy young and elderly Chinese subjects. The study of young subjects included the multiple ascending dose (MAD) arm (2 and 6 mg, N = 24) and the food effect arm (4 mg, N = 12) and was followed by the study of elderly subjects who were given (2 and 4 mg, N = 11). The noncompartmental analysis method was used to determine the pharmacokinetic parameters. The pharmacokinetics of fed versus fasted dose administration in the same subjects was assessed by 90% confidence interval. In the MAD arm, the accumulation ratios of DC20 in vivo were 2.29 and 2.15, respectively. In the food effect arm, compared with fasting administration, an area under the concentration-time curve from zero to t after a standard and high-fat diet orally administered slightly increased by about 19% and 29%, and the time to maximum concentration (T
MeSH term(s)	Aged ; Humans ; Acetylcholinesterase ; Administration, Oral ; Alzheimer Disease/drug therapy ; Area Under Curve ; Cholinesterase Inhibitors/adverse effects ; Dose-Response Relationship, Drug ; Double-Blind Method ; East Asian People ; Fasting ; Healthy Volunteers
Chemical Substances	Acetylcholinesterase (EC 3.1.1.7) ; Cholinesterase Inhibitors
Language	English
Publishing date	2023-02-26
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2433157-0
ISSN	1752-8062 ; 1752-8054
ISSN (online)	1752-8062
ISSN	1752-8054
DOI	10.1111/cts.13490
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Article ; Online: Safety and immunogenicity of a modified COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults: an open-labeled, two-centered and multi-arm randomised, phase 1 trial.

Gui, Yu-Zhou / Li, Xue-Ning / Li, Jing-Xin / Shen, Ming-Yun / Zhang, Mei-Wei / Cao, Ye / Xu, Hong-Rong / Li, Hui / Cheng, Jie / Pan, Liang / Yi, Ying-Lei / Liang, Li-Yu / Yu, Cheng-Yin / Liu, Gang-Yi / Yu, Chen / Hu, Bi-Jie / Zhu, Feng-Cai / Liang, Fei / Shen, Haifa /

Jia, Jing-Ying / Li, Hang-Wen / Zhou, Jian / Fan, Jia

EBioMedicine

2023 Volume 91, Page(s) 104586

Abstract: Background: We assessed the safety and immunogenicity of a core-shell structured lipopolyplex (LPP) based COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults.: Methods: We conducted an open-labeled, two-centered, and three- ... ...

Abstract	Background: We assessed the safety and immunogenicity of a core-shell structured lipopolyplex (LPP) based COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults. Methods: We conducted an open-labeled, two-centered, and three-arm randomised phase 1 trial. Healthy adults, who had completed a two-dose of inactivated COVID-19 vaccine for more than six months, were enrolled and randomized to receive a booster dose of COVILO (inactivated vaccine) (n = 20) or SW-BIC-213-25μg (n = 20), or SW-BIC-213-45μg (n = 20). The primary study endpoint was adverse events within 30 days post-boosting. The secondary endpoint was the titers of binding antibodies and neutralizing antibodies against the wild-type (WT) of SARS-CoV-2 as well as variants of concern in serum. The exploratory endpoint was the cellular immune responses. This trial was registered with http://www.chictr.org.cn (ChiCTR2200060355). Findings: Between Jun 6 and Jun 22, 2022, 60 participants were enrolled and randomized to receive a booster dose of SW-BIC-213 (25 μg, n = 20, or 45 μg, n = 20) or COVILO (n = 20). The baseline demographic characteristics of the participants at enrollment were similar among the treatment groups. For the primary outcome, injection site pain and fever were more common in the SW-BIC-213 groups (25 μg and 45 μg). Grade 3 fever was reported in 25% (5/20) of participants in the SW-BIC-213-45μg group but was resolved within 48 h after onset. No fatal events or adverse events leading to study discontinuation were observed. For secondary and exploratory outcomes, SW-BIC-213 elicited higher and longer humoral and cellular immune responses than that in the COVILO group. Interpretation: SW-BIC-213, a core-shell structured lipopolyplex (LPP) based mRNA vaccine, was safe, tolerable, and immunogenic as a heterologous booster in healthy Chinese adults. Funding: Shanghai Municipal Government, the Science and Technology and Economic Commission of Shanghai Pudong New Area, and mRNA Innovation and Translation Center of Shanghai.
MeSH term(s)	Adult ; Humans ; COVID-19 Vaccines/adverse effects ; COVID-19/prevention & control ; SARS-CoV-2 ; Antibodies, Viral ; China ; Antibodies, Neutralizing ; Double-Blind Method ; mRNA Vaccines
Chemical Substances	BIBP COVID-19 vaccine ; COVID-19 Vaccines ; Antibodies, Viral ; Antibodies, Neutralizing
Language	English
Publishing date	2023-04-24
Publishing country	Netherlands
Document type	Randomized Controlled Trial ; Clinical Trial, Phase I ; Journal Article
ZDB-ID	2851331-9
ISSN	2352-3964
ISSN (online)	2352-3964
DOI	10.1016/j.ebiom.2023.104586
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Article ; Online: Pharmacokinetics, mass balance, and metabolism of [

He, Yi-Fei / Liu, Yin / Yu, Jing-Hua / Cheng, Huan / Odilov, Abdullajon / Yang, Fei-Pu / Tian, Guang-Hui / Yao, Xiu-Mei / Duan, Hua-Qing / Yu, Cheng-Yin / Yu, Chen / Liu, Yan-Mei / Liu, Gang-Yi / Shen, Jing-Shan / Wang, Zhen / Diao, Xing-Xing

Acta pharmacologica Sinica

2022

Abstract: TPN171 is a novel phosphodiesterase-5 (PDE5) inhibitor used to treat pulmonary arterial hypertension (PAH) and erectile dysfunction (ED), which currently is undergoing phase II clinical trials in China. In this single-center, single-dose, nonrandomized, ... ...

Abstract	TPN171 is a novel phosphodiesterase-5 (PDE5) inhibitor used to treat pulmonary arterial hypertension (PAH) and erectile dysfunction (ED), which currently is undergoing phase II clinical trials in China. In this single-center, single-dose, nonrandomized, and open design study, radiolabeled [
Language	English
Publishing date	2022-06-08
Publishing country	United States
Document type	Journal Article
ZDB-ID	1360774-1
ISSN	1745-7254 ; 0253-9756 ; 1671-4083
ISSN (online)	1745-7254
ISSN	0253-9756 ; 1671-4083
DOI	10.1038/s41401-022-00922-6
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Article ; Online: A novel small molecule liver X receptor transcriptional regulator, nagilactone B, suppresses atherosclerosis in apoE-deficient mice.

Gui, Yuzhou / Yao, Sheng / Yan, Hong / Hu, Liang / Yu, Chengyin / Gao, Fei / Xi, Cong / Li, Huihui / Ye, Yang / Wang, Yiping

Cardiovascular research

2016 Volume 112, Issue 1, Page(s) 502–514

Abstract: Aims: Atherosclerosis is the most common cause of cardiovascular diseases, such as myocardial infarction and stroke. We hypothesized that nagilactone B (NLB), a small molecule extracted from the root bark of Podocarpus nagi (Podocarpaceae), suppresses ... ...

Abstract	Aims: Atherosclerosis is the most common cause of cardiovascular diseases, such as myocardial infarction and stroke. We hypothesized that nagilactone B (NLB), a small molecule extracted from the root bark of Podocarpus nagi (Podocarpaceae), suppresses atherosclerosis in an atherosclerotic mouse model. Methods and results: Male apoE-deficient mice on C57BL/6J background received NLB (10 and 30 mg/kg) for 12 weeks. Compared with the model group, NLB treatment (10 and 30 mg/kg) significantly reduced en face lesions of total aorta areas. In RAW264.7 cells, NLB significantly ameliorated cholesterol accumulation in macrophages via enhancing apolipoprotein A-I and HDL-mediated cholesterol efflux. Mechanistically, NLB induced messenger RNA and protein expression of the ATP-binding cassette transporter A1 (ABCA1) and G1 (ABCG1) in RAW264.7 and THP-1 cells. Liver X receptor (LXR) site mutations in the mouse ABCA1 promoter abrogated NLB-mediated luciferase reporter activity. LXRα and LXRβ small interfering RNA suppressed NLB-mediated induction of ABCA1 expression. Consistent with in vitro results, NLB induced ABCA1 expression and suppressed macrophage areas in the aortic sinus. Moreover, NLB treatment did not induce the protein expression of LXR in liver. Hepatic and intestinal cholesterol accumulation was significantly alleviated on NLB treatment. Besides, NLB significantly improved plasma lipid profiles in apoE-deficient mice. Conclusion: Selective LXR activation in macrophages with NLB induces ABCA1- and ABCG1-mediated cholesterol efflux while exerting minimal effects on lipogenesis and lipid accumulation in liver, resulting in regression of atherosclerosis, and therefore might be a promising strategy for therapeutics.
MeSH term(s)	ATP Binding Cassette Transporter 1/genetics ; ATP Binding Cassette Transporter 1/metabolism ; ATP Binding Cassette Transporter, Sub-Family G, Member 1/genetics ; ATP Binding Cassette Transporter, Sub-Family G, Member 1/metabolism ; Animals ; Aorta/drug effects ; Aorta/metabolism ; Aorta/pathology ; Aortic Diseases/genetics ; Aortic Diseases/metabolism ; Aortic Diseases/pathology ; Aortic Diseases/prevention & control ; Apolipoprotein A-I/metabolism ; Apolipoproteins E/deficiency ; Apolipoproteins E/genetics ; Atherosclerosis/genetics ; Atherosclerosis/metabolism ; Atherosclerosis/pathology ; Atherosclerosis/prevention & control ; Binding Sites ; Cell Line, Tumor ; Cholesterol, HDL/metabolism ; Disease Models, Animal ; Diterpenes/pharmacology ; Dose-Response Relationship, Drug ; Genetic Predisposition to Disease ; Humans ; Hypolipidemic Agents/pharmacology ; Liver X Receptors/agonists ; Liver X Receptors/drug effects ; Liver X Receptors/genetics ; Macrophages/drug effects ; Macrophages/metabolism ; Macrophages/pathology ; Male ; Mice ; Mice, Inbred C57BL ; Mice, Knockout ; Mutation ; Phenotype ; Plaque, Atherosclerotic ; Promoter Regions, Genetic ; RAW 264.7 Cells ; RNA Interference ; Signal Transduction/drug effects ; Transfection
Chemical Substances	ABCA1 protein, human ; ABCA1 protein, mouse ; ABCG1 protein, human ; ABCG1 protein, mouse ; ATP Binding Cassette Transporter 1 ; ATP Binding Cassette Transporter, Sub-Family G, Member 1 ; Apolipoprotein A-I ; Apolipoproteins E ; Cholesterol, HDL ; Diterpenes ; Hypolipidemic Agents ; Liver X Receptors ; nagilactone C (24338-53-2)
Language	English
Publishing date	2016-07-26
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	80340-6
ISSN	1755-3245 ; 0008-6363
ISSN (online)	1755-3245
ISSN	0008-6363
DOI	10.1093/cvr/cvw183
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Article ; Online: Proteomics analysis reveals a potential new target protein for the lipid-lowering effect of Berberine8998.

Yu, Cheng-Yin / Liu, Gang-Yi / Liu, Xiao-Hui / Gui, Yu-Zhou / Liu, Hai-Ming / Zheng, Hong-Chao / Gorecki, Darek C / Patel, Asmita V / Yu, Chen / Wang, Yi-Ping

Acta pharmacologica Sinica

2018 Volume 39, Issue 9, Page(s) 1473–1482

Abstract: Berberine8998 is a newly synthesized berberine derivative with better lipid-lowering activity and improved absorption. The objective of this study was to investigate the effects of berberine8998 on serum cholesterol and lipid levels in vivo and to ... ...

Abstract	Berberine8998 is a newly synthesized berberine derivative with better lipid-lowering activity and improved absorption. The objective of this study was to investigate the effects of berberine8998 on serum cholesterol and lipid levels in vivo and to examine the mechanisms involved. Hamsters on high-fat diet (HFD) were administered berberine or berberine8998 (50 mg·kg
MeSH term(s)	Animals ; Anticholesteremic Agents/pharmacokinetics ; Anticholesteremic Agents/therapeutic use ; Berberine/analogs & derivatives ; Berberine/pharmacokinetics ; Berberine/therapeutic use ; Biological Availability ; Cholesterol, LDL/blood ; Cholesterol, LDL/metabolism ; Cricetinae ; Diet, High-Fat ; Hep G2 Cells ; Humans ; Hypercholesterolemia/drug therapy ; Male ; Proteomics ; Rats, Sprague-Dawley ; Triglycerides/blood ; Triglycerides/metabolism
Chemical Substances	Anticholesteremic Agents ; Cholesterol, LDL ; Triglycerides ; Berberine (0I8Y3P32UF)
Language	English
Publishing date	2018-04-12
Publishing country	United States
Document type	Journal Article
ZDB-ID	1360774-1
ISSN	1745-7254 ; 0253-9756 ; 1671-4083
ISSN (online)	1745-7254
ISSN	0253-9756 ; 1671-4083
DOI	10.1038/aps.2017.200
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Article ; Online: Pharmacokinetic study of melamine in rhesus monkey after a single oral administration of a tolerable daily intake dose.

Liu, Gangyi / Li, Shuijun / Jia, Jingying / Yu, Chengyin / He, Jian / Yu, Chen / Zhu, Jianmin

Regulatory toxicology and pharmacology : RTP

2010 Volume 56, Issue 2, Page(s) 193–196

Abstract: To perform pharmacokinetic study of melamine in rhesus monkey, melamine was orally administered to three experimental monkeys at a single dose of 1.4 mg/kg body weight. Plasma and urine were collected for the determination of melamine and cyanuric acid ... ...

Abstract	To perform pharmacokinetic study of melamine in rhesus monkey, melamine was orally administered to three experimental monkeys at a single dose of 1.4 mg/kg body weight. Plasma and urine were collected for the determination of melamine and cyanuric acid with a liquid chromatography tandem mass spectrometry method. The mean+/-SD area under the concentration-time curve from time zero to 48 h (AUC0-t) was 14,145+/-2002 microg/Lh. The maximum concentration of melamine in plasma (C(max)) was 1767+/-252 microg/L. The time to maximum concentration (T(max)) was 2.67+/-1.16 h and the half-life of melamine in plasma (t(1/2)) was 4.41+/-0.43 h. Following oral administration, melamine was rapidly excreted, mainly through urinary clearance. No significant correlation was found between melamine and cyanuric acid, suggesting that cyanuric acid may not be derived from melamine.
MeSH term(s)	Administration, Oral ; Animals ; Dose-Response Relationship, Drug ; Female ; Macaca mulatta ; Male ; Time Factors ; Triazines/administration & dosage ; Triazines/pharmacokinetics
Chemical Substances	Triazines ; melamine (N3GP2YSD88)
Language	English
Publishing date	2010-03
Publishing country	Netherlands
Document type	Comparative Study ; Journal Article
ZDB-ID	604672-1
ISSN	1096-0295 ; 0273-2300
ISSN (online)	1096-0295
ISSN	0273-2300
DOI	10.1016/j.yrtph.2009.09.014
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Zs.A 1711: Show issues

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Article ; Online: Determination of melamine and cyanuric acid in human urine by a liquid chromatography tandem mass spectrometry.

Zhang, Mengqi / Li, Shuijun / Yu, Chengyin / Liu, Gangyi / Jia, Jingying / Lu, Chuan / He, Jian / Ma, Yinghua / Zhu, Jianmin / Yu, Chen

Journal of chromatography. B, Analytical technologies in the biomedical and life sciences

2010 Volume 878, Issue 9-10, Page(s) 758–762

Abstract: Melamine was found to be the etiological factor for the urinary stones epidemic in infants and young children in China in 2008. Urine level of melamine and its analog cyanuric acid may be useful markers for the evaluation of toxic effects. Liquid ... ...

Abstract	Melamine was found to be the etiological factor for the urinary stones epidemic in infants and young children in China in 2008. Urine level of melamine and its analog cyanuric acid may be useful markers for the evaluation of toxic effects. Liquid chromatography tandem mass spectrometry methods for the individual determination of melamine and cyanuric acid in human urine are described. Using isotope labeled internal standards during liquid-liquid extraction, the method was fully validated by verifying specificity, linearity, LLOQ, intra- and inter-assay precision and accuracy, matrix effect, recovery and stability. Calibration curves with good linearity (r=0.9999) over the concentration range from 10 to 5000 ng/ml, intra-assay precision <10% and inter-assay precision <15%, accuracy between 93.0 and 111.6% were obtained with multiple reaction monitoring mode for melamine and cyanuric acid in human urine. The methods were successfully applied to the analysis of urine samples collected from 86 infants and 110 adults.
MeSH term(s)	Adult ; Child ; Child, Preschool ; Chromatography, High Pressure Liquid/methods ; Female ; Humans ; Infant ; Male ; Middle Aged ; Tandem Mass Spectrometry/methods ; Triazines/urine
Chemical Substances	Triazines ; cyanuric acid (H497R4QKTZ) ; melamine (N3GP2YSD88)
Language	English
Publishing date	2010-03-15
Publishing country	Netherlands
Document type	Evaluation Studies ; Journal Article
ZDB-ID	1180823-8
ISSN	1873-376X ; 0378-4347 ; 1570-0232 ; 1387-2273
ISSN (online)	1873-376X
ISSN	0378-4347 ; 1570-0232 ; 1387-2273
DOI	10.1016/j.jchromb.2010.01.020
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Article: Development and validation of a liquid chromatography-isotope dilution tandem mass spectrometry for determination of olanzapine in human plasma and its application to bioavailability study.

Zhang, Meng-Qi / Jia, Jing-Ying / Lu, Chuan / Liu, Gang-Yi / Yu, Cheng-Yin / Gui, Yu-Zhou / Liu, Yun / Liu, Yan-Mei / Wang, Wei / Li, Shui-Jun / Yu, Chen

Yao xue xue bao = Acta pharmaceutica Sinica

2010 Volume 45, Issue 6, Page(s) 767–771

Abstract: A simple, reliable and sensitive liquid chromatography-isotope dilution mass spectrometry (LC-ID/MS) was developed and validated for quantification of olanzapine in human plasma. Plasma samples (50 microL) were extracted with tert-butyl methyl ether and ... ...

Abstract	A simple, reliable and sensitive liquid chromatography-isotope dilution mass spectrometry (LC-ID/MS) was developed and validated for quantification of olanzapine in human plasma. Plasma samples (50 microL) were extracted with tert-butyl methyl ether and isotope-labeled internal standard (olanzapine-D3) was used. The chromatographic separation was performed on XBridge Shield RP 18 (100 mm x 2.1 mm, 3.5 microm, Waters). An isocratic program was used at a flow rate of 0.4 m x min(-1) with mobile phase consisting of acetonitrile and ammonium buffer (pH 8). The protonated ions of analytes were detected in positive ionization by multiple reactions monitoring (MRM) mode. The plasma method, with a lower limit of quantification (LLOQ) of 0.1 ng x mL(-1), demonstrated good linearity over a range of 0.1 - 30 ng x mL(-1) of olanzapine. Specificity, linearity, accuracy, precision, recovery, matrix effect and stability were evaluated during method validation. The validated method was successfully applied to analyzing human plasma samples in bioavailability study.
MeSH term(s)	Antipsychotic Agents/blood ; Antipsychotic Agents/pharmacokinetics ; Benzodiazepines/blood ; Benzodiazepines/pharmacokinetics ; Biological Availability ; Chromatography, Liquid/methods ; Humans ; Indicator Dilution Techniques ; Isotope Labeling ; Reproducibility of Results ; Sensitivity and Specificity ; Tandem Mass Spectrometry/methods
Chemical Substances	Antipsychotic Agents ; Benzodiazepines (12794-10-4) ; olanzapine (N7U69T4SZR)
Language	English
Publishing date	2010-06
Publishing country	China
Document type	Journal Article ; Validation Studies
ZDB-ID	788758-9
ISSN	0513-4870
ISSN	0513-4870
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