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Article: Microglial M2 Polarization Mediated the Neuroprotective Effect of Morroniside in Transient MCAO-Induced Mice.

Liu, Hao / Ou, Mei-Xian / Han, Qiao-Qiao

2021 Volume 12, Page(s) 784329

Abstract: Morroniside, a secoiridoid glycoside ... ...

Abstract	Morroniside, a secoiridoid glycoside from
Language	English
Publishing date	2021-11-19
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2587355-6
ISSN	1663-9812
ISSN	1663-9812
DOI	10.3389/fphar.2021.784329
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Article ; Online: A single-dose, randomized crossover study in healthy Chinese subjects to evaluate pharmacokinetics and bioequivalence of two capsules of calcium dobesilate 0.5 g under fasting and fed conditions.

Liu, Yanmei / Cheng, Jie / Liang, Liyu / Qian, Weigang / Ou, Meixian / Zhang, Mengqi / Wang, Yijun / Wang, Yan / Peng, Ka / Jia, Jingying

PloS one

2023 Volume 18, Issue 4, Page(s) e0284576

Abstract: Objectives: To compare the rate and extent of absorption of a launched generic calcium dobesilate capsule versus the branded reference formulation under fasting and fed conditions in healthy Chinese subjects, and to assess their bioequivalence and ... ...

Abstract	Objectives: To compare the rate and extent of absorption of a launched generic calcium dobesilate capsule versus the branded reference formulation under fasting and fed conditions in healthy Chinese subjects, and to assess their bioequivalence and tolerability. Methods: This single-dose, open-label, randomized-sequence, 2-period crossover bioequivalence study was conducted on healthy Chinese volunteers aged 18 to 45 years. Subjects received a single 0.5 g dose of calcium dobesilate capsule under fasting or fed conditions, with a 3-day washout period between doses of the test (T) and reference (R) formulations. Blood samples were collected before and up to 24 hours after administration. The plasma concentration of calcium dobesilate was determined by a validated Liquid chromatography-tandem mass spectrometry method. Non-compartmental analysis was applied to identify the pharmacokinetic (PK) properties. The primary PK parameters including the maximal plasma concentration (Cmax), the area under the plasma concentration-time curve (AUC0-t), and the AUC extrapolated to infinity (AUC0-inf) were used for bioequivalence evaluation. Results: The mean of PK parameters for T and R capsules under fasting (fed) condition were: Cmax, 13.57 (6.71) and 12.59 (7.25) μg/mL; AUC0-t, 97.32 (79.74) and 96.97 (80.71) hμg/mL; AUC0-inf, 101.68 (88.01) and 101.64 (87.81) hμg/mL. The 90% confidence intervals (CIs) of GMRs under fasting (fed) condition were: Cmax, 97.91%-116.62% (88.63%-96.53%); AUC0-t, 97.15%-104.00% (96.58%-101.39%); and AUC0-inf, 97.19%-102.89% (98.67%-103.99%). These 90% CIs were all within the bioequivalence range of 80%-125%. All adverse events were mild. Conclusion: In this study, the T calcium dobesilate 0.5 g capsule was bioequivalent to the reference product under both fasting and fed conditions. Taking food would slow down its rate and reduce its amount of absorption. Both formulations were generally well tolerated.
MeSH term(s)	Humans ; Area Under Curve ; Calcium Dobesilate/blood ; Calcium Dobesilate/pharmacokinetics ; Capsules ; Cross-Over Studies ; East Asian People ; Fasting/blood ; Fasting/physiology ; Feeding Behavior/physiology ; Healthy Volunteers ; Therapeutic Equivalency ; Drugs, Generic/pharmacokinetics ; Adolescent ; Young Adult ; Adult ; Middle Aged ; Gastrointestinal Absorption/physiology ; Prescription Drugs/pharmacokinetics
Chemical Substances	Calcium Dobesilate (5921X1560Q) ; Capsules ; Drugs, Generic ; Prescription Drugs
Language	English
Publishing date	2023-04-21
Publishing country	United States
Document type	Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0284576
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Article ; Online: A novel automated multi-cycle magnetic solid-phase extraction coupled to LC-MS/MS to study the disorders of six functional B vitamins in patients with gastroenterology and hyperhomocysteinemia.

Gu, Yuting / Jiang, Fengli / Yuan, Xiangmei / Yu, Fan / Liang, Yan / Xiao, Can / Yang, Shuangshuang / Zhang, Meiwei / Ou, Meixian / Xu, Yang / Yu, Chen / Jia, Jingying / Li, Jie / Liu, Gangyi / Lu, Youli

Journal of pharmaceutical and biomedical analysis

2024 Volume 241, Page(s) 115989

Abstract: B vitamins are essential for human life and their disorders can cause a variety of diseases. Solid-phase extraction (SPE) coupled to LC-MS/MS is a preferred technique for determining multiple B vitamins, however, their complexity in real biological ... ...

Abstract	B vitamins are essential for human life and their disorders can cause a variety of diseases. Solid-phase extraction (SPE) coupled to LC-MS/MS is a preferred technique for determining multiple B vitamins, however, their complexity in real biological matrices makes it hard to achieve satisfactory recovery and accuracy when simultaneous detection. In this study, a novel automated multi-cycle magnetic SPE (MSPE) coupled to the LC-MS/MS method was established using a mixed-mode anion exchange magnetic adsorbent for the simultaneous extraction of six functional B vitamins, including methylmalonic acid, riboflavin, pantothenic acid, 4-pyridoxic acid, folic acid, and 5-methyltetrahydrofolate. After three consecutive MSPE cycles, the recoveries of all analytes were between 51.5% and 89.6%. The method exhibited excellent sensitivity and linearity, with a dynamic range of 200-fold (R > 0.99 for all analytes), exceptional accuracy (ranging between 95.4% and 105.6%) and precision (with RSDs ≤ 6.2%) without significant matrix effects or interferences. Compared to manual SPE method, the automated multi-cycle MSPE method has better feasibility and greater vitamin coverage. It shows a high correlation with the manual method for the detection of 5-methyltetrahydrofolate and folate (R > 0.99). A study of patients from the gastroenterology department showed that those undergoing surgery and those with malignancies may be at risk of folate deficiency. In addition, patients with hyperhomocystinemia had higher levels of methylmalonic acid and lower levels of 5-methyltetrahydrofolate, which correlated with homocysteine levels (R = 0.404 and -0.311, respectively) and showed dose-response relationships. This method is highly automated and cost-effective, with minimal systematic error, making it suitable for the analysis of clinical samples.
MeSH term(s)	Humans ; Chromatography, Liquid/methods ; Vitamin B Complex ; Liquid Chromatography-Mass Spectrometry ; Gastroenterology ; Hyperhomocysteinemia ; Methylmalonic Acid ; Tandem Mass Spectrometry/methods ; Vitamin A ; Folic Acid ; Solid Phase Extraction/methods ; Magnetic Phenomena ; Chromatography, High Pressure Liquid/methods
Chemical Substances	Vitamin B Complex (12001-76-2) ; Methylmalonic Acid (8LL8S712J7) ; Vitamin A (11103-57-4) ; Folic Acid (935E97BOY8)
Language	English
Publishing date	2024-01-19
Publishing country	England
Document type	Journal Article
ZDB-ID	604917-5
ISSN	1873-264X ; 0731-7085
ISSN (online)	1873-264X
ISSN	0731-7085
DOI	10.1016/j.jpba.2024.115989
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Article ; Online: A phase I study comparing the pharmacokinetics and safety of HS628 (tocilizumab biosimilar) and reference tocilizumab in healthy male subjects.

Qian, Hongjie / Cheng, Jie / Gui, Yuzhou / Wang, Wei / Liang, Liyu / Zhu, Huijuan / Wu, Qingqing / Ou, Meixian / Chen, Qian / Yu, Chen / Jia, Jingying

Clinical and translational science

2023 Volume 16, Issue 9, Page(s) 1704–1712

Abstract: This study aimed to evaluate the pharmacokinetic (PK) similarity of the proposed biosimilar HS628 compared with the reference tocilizumab (Actemra®) and also to demonstrate similar safety and immunogenicity profiles in healthy Chinese male subjects. ... ...

Abstract	This study aimed to evaluate the pharmacokinetic (PK) similarity of the proposed biosimilar HS628 compared with the reference tocilizumab (Actemra®) and also to demonstrate similar safety and immunogenicity profiles in healthy Chinese male subjects. Eighty eligible subjects were randomized into two treatment groups in a 1:1 ratio to receive a single intravenous infusion of HS628 or tocilizumab at 4 mg/kg over 60 min. Blood samples were collected at the scheduled time points for PK and immunogenicity analysis. PK biosimilarity was determined using the standard bioequivalence criteria 80%-125%. A total of 77 subjects received the study drug and completed the study. The main PK parameters were similar for the test and reference groups. The ratio of geometric least-squares means (GMR) and its 90% CIs for AUC
MeSH term(s)	Humans ; Male ; Biosimilar Pharmaceuticals ; Antibodies, Monoclonal, Humanized/adverse effects ; Therapeutic Equivalency ; Area Under Curve ; Healthy Volunteers ; Double-Blind Method
Chemical Substances	tocilizumab (I031V2H011) ; Biosimilar Pharmaceuticals ; Antibodies, Monoclonal, Humanized
Language	English
Publishing date	2023-07-18
Publishing country	United States
Document type	Randomized Controlled Trial ; 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.13584
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Article ; Online: Effect of food on the single-dose pharmacokinetics and tolerability of savolitinib in Chinese healthy volunteers.

Ding, Qichen / Ou, Meixian / Zhu, Huijuan / Wang, Yijun / Jia, Jingying / Sai, Yang / Chen, Qian / Wang, Jian

Fundamental & clinical pharmacology

2021 Volume 36, Issue 1, Page(s) 210–217

Abstract: The aim of this study was to investigate the effect of a high-fat and high-calorie meal on the single-dose pharmacokinetics (PK) and tolerability of savolitinib. The study included two phases: safety run-in phase and food effect assessment phase. In the ... ...

Abstract	The aim of this study was to investigate the effect of a high-fat and high-calorie meal on the single-dose pharmacokinetics (PK) and tolerability of savolitinib. The study included two phases: safety run-in phase and food effect assessment phase. In the safety run-in phase, 9 healthy male volunteers were divided into three groups to be administered a single oral dose of savolitinib tablets at 200, 400, and 600 mg. In the food effect assessment phase, 16 healthy male volunteers received a single 600 mg dose of savolitinib tablets following an overnight fast or a high-fat and high-calorie breakfast prior to dosing. Blood samples were collected at the designated time points for pharmacokinetic analysis. Safety and tolerability were assessed throughout the study by clinical assessments and adverse events (AEs). A total of 25 healthy male volunteers were enrolled in the study, including 9 in the safety run-in phase and 16 in the food effect assessment phase. In the food effect assessment phase, the geometric mean ratios (90% confidence interval) for savolitinib dosed under the fed condition compared with that dosed under the fasting condition were 102.7% (84.9%, 124.2%) and 117.1% (103.9%, 131.9%) for C
MeSH term(s)	Administration, Oral ; Area Under Curve ; China ; Cross-Over Studies ; Fasting ; Food-Drug Interactions ; Healthy Volunteers ; Humans ; Male ; Pyrazines ; Tablets ; Triazines
Chemical Substances	Pyrazines ; Tablets ; Triazines ; 1-(1-(imidazo(1,2-a)pyridin-6-yl)ethyl)-6-(1-methyl-1H-pyrazol-4-yl)-1H-(1,2,3)triazolo(4,5-b)pyrazine (2A2DA6857R)
Language	English
Publishing date	2021-06-16
Publishing country	England
Document type	Journal Article
ZDB-ID	639134-5
ISSN	1472-8206 ; 0767-3981
ISSN (online)	1472-8206
ISSN	0767-3981
DOI	10.1111/fcp.12697
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Article ; Online: Mouse strain specificity of DAAO inhibitors-mediated antinociception.

Liu, Hao / Zhou, Yu-Cong / Wang, Zi-Ying / Gong, Nian / Lu, Jin-Miao / Apryani, eVhy / Han, Qiao-Qiao / Wang, Yong-Xiang / Ou, Mei-Xian

Pharmacology research & perspectives

2021 Volume 9, Issue 2, Page(s) e00727

Abstract: D-Amino acid oxidase (DAAO) specifically catalyzes the oxidative deamination of neutral and polar D-amino acids and finally yields byproducts of hydrogen peroxide. Our previous work demonstrated that the spinal astroglial DAAO/hydrogen peroxide ( ... ...

Abstract	D-Amino acid oxidase (DAAO) specifically catalyzes the oxidative deamination of neutral and polar D-amino acids and finally yields byproducts of hydrogen peroxide. Our previous work demonstrated that the spinal astroglial DAAO/hydrogen peroxide (H
MeSH term(s)	Analgesics/administration & dosage ; Analgesics/pharmacokinetics ; Animals ; Biological Variation, Population ; D-Amino-Acid Oxidase/antagonists & inhibitors ; D-Amino-Acid Oxidase/metabolism ; Glutathione/analysis ; Glutathione/metabolism ; Glutathione Peroxidase/analysis ; Glutathione Peroxidase/metabolism ; Male ; Mice ; Mice, Inbred BALB C ; Mice, Inbred C57BL ; Nociception/drug effects ; Spinal Cord/drug effects ; Spinal Cord/metabolism
Chemical Substances	Analgesics ; Glutathione Peroxidase (EC 1.11.1.9) ; Dao1 protein, mouse (EC 1.4.3.-) ; D-Amino-Acid Oxidase (EC 1.4.3.3) ; Glutathione (GAN16C9B8O)
Language	English
Publishing date	2021-03-12
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2740389-0
ISSN	2052-1707 ; 2052-1707
ISSN (online)	2052-1707
ISSN	2052-1707
DOI	10.1002/prp2.727
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Article ; Online: Feasibility study of the pharmacology of local application of amifostine (WR-2721) to the buccal mucosa in guinea pigs.

Li, Changjiang / Wang, Shengzi / Huang, Taomin / Chen, Nianzu / Ou, Meixian

Pharmacology

2013 Volume 91, Issue 5-6, Page(s) 281–286

Abstract: Background/aims: We have undertaken this study to investigate the feasibility of topical application of the radioprotective compound WR-2721 to the buccal mucosa.: Methods: Saliva samples were collected from 5 volunteers and were reconstituted in 3 ... ...

Abstract	Background/aims: We have undertaken this study to investigate the feasibility of topical application of the radioprotective compound WR-2721 to the buccal mucosa. Methods: Saliva samples were collected from 5 volunteers and were reconstituted in 3 amifostine solutions. Measurements of amifostine and WR-1065 contents were performed at 6 different time points. Young-adult guinea pigs were topically administered amifostine 50 and 100 mg to each buccal mucosa. At 0, 15 and 30 min after application, the blood samples obtained from the heart and the buccal tissues were prepared for the analysis of amifostine and WR-1065. Results: There was no significant difference between the 3 concentrations of amifostine in saliva in vitro at any of the 6 study time points (p > 0.05). No WR-1065 was detected in saliva. In the guinea pigs from groups A and B, there were significant differences in concentrations of amifostine and WR-1065 in the tissues between the 0-min and 15-min subgroups and between the 0-min and 30-min subgroups (p < 0.05). The concentrations of amifostine and WR-1065 from the 15-min and 30-min subgroups did not differ statistically (p > 0.05). Conclusions: It is feasible to administer topical amifostine (WR-2721) to mucosa to prevent radiation-induced oral mucositis, and systemic absorption is negligible. Relatively high concentrations of amifostine in human saliva in vitro were maintained, although some inconsistent changes are observed.
MeSH term(s)	Administration, Buccal ; Amifostine/administration & dosage ; Amifostine/pharmacokinetics ; Animals ; Feasibility Studies ; Guinea Pigs ; Humans ; Mercaptoethylamines/metabolism ; Mouth Mucosa/metabolism ; Myocardium/metabolism ; Radiation-Protective Agents/administration & dosage ; Radiation-Protective Agents/pharmacokinetics ; Saliva/metabolism
Chemical Substances	Mercaptoethylamines ; Radiation-Protective Agents ; N-(2-mercaptoethyl)-1,3-diaminopropane (05P3K9I49L) ; Amifostine (M487QF2F4V)
Language	English
Publishing date	2013-05-31
Publishing country	Switzerland
Document type	Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	206671-3
ISSN	1423-0313 ; 0031-7012
ISSN (online)	1423-0313
ISSN	0031-7012
DOI	10.1159/000350396
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Article: Feasibility Study of the Pharmacology of Local Application of Amifostine (WR-2721) to the Buccal Mucosa in Guinea Pigs

Li, Changjiang / Wang, Shengzi / Huang, Taomin / Chen, Nianzu / Ou, Meixian

Pharmacology

2013 Volume 91, Issue 5-6, Page(s) 281–286

Abstract: Background/Aims: We have undertaken this study to investigate the feasibility of topical application of the radioprotective compound WR-2721 to the buccal mucosa. Methods: Saliva samples were collected from 5 volunteers and were reconstituted in 3 ... ...

Institution	Departments of Otorhinolaryngology Radiation Oncology and Pharmacy, Eye-Ear-Nose-Throat Hospital of Fudan University, and Central Laboratory, Shanghai Xuhui Central Hospital, Shanghai, China
Abstract	Background/Aims: We have undertaken this study to investigate the feasibility of topical application of the radioprotective compound WR-2721 to the buccal mucosa. Methods: Saliva samples were collected from 5 volunteers and were reconstituted in 3 amifostine solutions. Measurements of amifostine and WR-1065 contents were performed at 6 different time points. Young-adult guinea pigs were topically administered amifostine 50 and 100 mg to each buccal mucosa. At 0, 15 and 30 min after application, the blood samples obtained from the heart and the buccal tissues were prepared for the analysis of amifostine and WR-1065. Results: There was no significant difference between the 3 concentrations of amifostine in saliva in vitro at any of the 6 study time points (p > 0.05). No WR-1065 was detected in saliva. In the guinea pigs from groups A and B, there were significant differences in concentrations of amifostine and WR-1065 in the tissues between the 0-min and 15-min subgroups and between the 0-min and 30-min subgroups (p < 0.05). The concentrations of amifostine and WR-1065 from the 15-min and 30-min subgroups did not differ statistically (p > 0.05). Conclusions: It is feasible to administer topical amifostine (WR-2721) to mucosa to prevent radiation-induced oral mucositis, and systemic absorption is negligible. Relatively high concentrations of amifostine in human saliva in vitro were maintained, although some inconsistent changes are observed.
Keywords	Amifostine (WR-2721) ; WR-1065 ; Feasibility ; Local application ; Guinea pigs
Language	English
Publishing date	2013-05-31
Publisher	S. Karger AG
Publishing place	Basel, Switzerland
Document type	Article
Note	Original Paper
ZDB-ID	206671-3
ISSN	1423-0313 ; 0031-7012
ISSN (online)	1423-0313
ISSN	0031-7012
DOI	10.1159/000350396
Database	Karger publisher's database

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Article ; Online: Feasibility Study of the Pharmacology of Local Application of Amifostine (WR-2721) to the Buccal Mucosa in Guinea Pigs

Li, Changjiang / Wang, Shengzi / Huang, Taomin / Chen, Nianzu / Ou, Meixian

Pharmacology - International Journal of Experimental and Clinical Pharmacology

2013 Volume 91, Issue 5-6, Page(s) 281–286

Abstract	Background/Aims: We have undertaken this study to investigate the feasibility of topical application of the radioprotective compound WR-2721 to the buccal mucosa. Methods: Saliva samples were collected from 5 volunteers and were reconstituted in 3 amifostine solutions. Measurements of amifostine and WR-1065 contents were performed at 6 different time points. Young-adult guinea pigs were topically administered amifostine 50 and 100 mg to each buccal mucosa. At 0, 15 and 30 min after application, the blood samples obtained from the heart and the buccal tissues were prepared for the analysis of amifostine and WR-1065. Results: There was no significant difference between the 3 concentrations of amifostine in saliva in vitro at any of the 6 study time points (p > 0.05). No WR-1065 was detected in saliva. In the guinea pigs from groups A and B, there were significant differences in concentrations of amifostine and WR-1065 in the tissues between the 0-min and 15-min subgroups and between the 0-min and 30-min subgroups (p < 0.05). The concentrations of amifostine and WR-1065 from the 15-min and 30-min subgroups did not differ statistically (p > 0.05). Conclusions: It is feasible to administer topical amifostine (WR-2721) to mucosa to prevent radiation-induced oral mucositis, and systemic absorption is negligible. Relatively high concentrations of amifostine in human saliva in vitro were maintained, although some inconsistent changes are observed.
Keywords	Amifostine (WR-2721) ; WR-1065 ; Feasibility ; Local application ; Guinea pigs
Language	English
Publisher	S. Karger AG
Publishing place	Basel
Publishing country	Switzerland
Document type	Article ; Online
ZDB-ID	206671-3
ISSN	1423-0313 ; 0031-7012 ; 0031-7012
ISSN (online)	1423-0313
ISSN	0031-7012
DOI	10.1159/000350396
Database	Karger publisher's database

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Article ; Online: LC-MS/MS Method for Serum Creatinine: Comparison with Enzymatic Method and Jaffe Method.

Ou, Meixian / Song, Yunxiao / Li, Shuijun / Liu, Gangyi / Jia, Jingying / Zhang, Menqi / Zhang, Haichen / Yu, Chen

PloS one

2015 Volume 10, Issue 7, Page(s) e0133912

Abstract: Accurate quantification of creatinine (Cre) is important to estimate glomerular filtration rate (GFR). Differences among various methods of Cre quantification were previously noted. This study aims to develop a liquid chromatography tandem mass ... ...

Abstract	Accurate quantification of creatinine (Cre) is important to estimate glomerular filtration rate (GFR). Differences among various methods of Cre quantification were previously noted. This study aims to develop a liquid chromatography tandem mass spectrometry (LC-MS/MS) method for serum Cre and compare this method with clinical routine methods. LC-MS/MS analysis was performed on API 4000 triple quadrupole mass spectrometer coupled with an Agilent 1200 liquid chromatography system. After adding isotope-labeled Cre-d3 as internal standard, serum samples were prepared via a one-step protein precipitation with methanol. The LC-MS/MS method was compared with frequently used enzymatic method and Jaffe method. This developed method, with a total run time of 3 min, had a lower limit of quantification of 4.4 μmol/L, a total imprecision of 1.15%-3.84%, and an average bias of 1.06%. No significant matrix effect, carryover, and interference were observed for the LC-MS/MS method. The reference intervals of serum Cre measured by LC-MS/MS assay were 41-79 μmol/L for adult women, and 46-101 μmol/L for adult men. Using LC-MS/MS as a reference, the enzymatic method showed an average bias of -2.1% and the Jaffe method showed a substantial average bias of 11.7%. Compared with the LC-MS/MS method, significant negative bias was observed for the enzymatic and Jaffe methods in hemolytic and lipimic samples. We developed a simple, specific, and accurate LC-MS/MS method to analyze serum Cre. Discordance existed among different methods.
MeSH term(s)	Chromatography, Liquid/methods ; Creatinine/blood ; Female ; Glomerular Filtration Rate/physiology ; Humans ; Male ; Tandem Mass Spectrometry/methods
Chemical Substances	Creatinine (AYI8EX34EU)
Language	English
Publishing date	2015
Publishing country	United States
Document type	Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
ISSN	1932-6203
ISSN (online)	1932-6203
DOI	10.1371/journal.pone.0133912
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