Delving into the Latest Updates on 广东八加一医药有限公司 with Synapse

概览

关联

1

项与广东八加一医药有限公司相关的药物

Malifutai

吗利福肽

靶点

EEF1A1 x eNOS

作用机制

EEF1A1抑制剂 [+1]

在研机构

八加一药业股份有限公司

原研机构

广东八加一医药有限公司

在研适应症

缺血性卒中 [+1]

非在研适应症-

最高研发阶段临床2期

首次获批国家/地区-

首次获批日期-

3

项与广东八加一医药有限公司相关的临床试验

CTR20211420 / Completed临床1期

中国健康受试者单次静脉滴注（IV）BJY-801的药代动力学研究

评估中国健康受试者单次静脉滴注（Ⅳ）给药后BJY-801的安全性、耐受性及药代动力学特征。

开始日期2021-07-13

申办/合作机构

广东八加一医药有限公司

[+1]

CTR20202066 / Completed临床1期

中国健康受试者单次静脉滴注BJY-801的耐受性研究

根据非临床研究及已完成临床研究（MLFT-protocol-01）数据分析判断，需进一步探索BJY-801在中国成年健康人体单次给药的安全剂量范围，评估健康人体单次静脉滴注BJY-801的安全性和耐受性，为制定多次耐受和药代动力学研究及Ⅱ期临床试验给药方案提供依据。

开始日期2020-10-22

申办/合作机构

广东八加一医药有限公司

[+1]

CTR20170068 / Completed临床1期

中国健康志愿者单次静滴注射用吗利福肽的耐受性和药代动力学研究临床试验

观察健康人体单次接受滴注注射用吗利福肽的安全性和耐受性，评估注射用吗利福肽在健康人体单次给药的安全剂量范围及其在中国健康人体内的药代动力学特征，为制定多次耐受和药代动力学研究及II期临床试验给药方案提供依据。

开始日期2017-05-16

申办/合作机构

广东八加一医药有限公司

[+1]

100 项与广东八加一医药有限公司相关的临床结果

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0 项与广东八加一医药有限公司相关的专利（医药）

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1

项与广东八加一医药有限公司相关的文献（医药）

2018-08-01·Journal of Pharmaceutical and Biomedical Analysis3区 · 医学

A validated UPLC–MS/MS method for the quantitation of an unstable peptide, monocyte locomotion inhibitory factor (MLIF) in human plasma and its application to a pharmacokinetic study

3区 · 医学

Article

作者: Wang, Hongyun ; Jiang, Ji ; Li, Cheng ; Huang, Jinghua ; Liu, Xuemei ; Wang, Xizhu ; Hu, Pei ; Li, Jin ; Wang, Yongsheng

Monocyte locomotion inhibitory factor (MLIF, Met-Gln-Cys-Asn-Ser), a pentapeptide with anti-inflammatory activity, was developed for neural protection in acute ischemic stroke. Determination of MLIF in human plasma samples is of great importance for pharmacokinetic evaluation in clinical studies. A reliable and sensitive method based on ultra-performance liquid chromatography coupled with tandem mass spectrometry (UPLC-MS/MS) was established for the measurement of MLIF in human plasma. Instability of peptide in matrix was the primary challenge in method development, which was properly resolved by addition of acidification reagents like sulfuric acid. Samples were prepared by protein precipitation and then analyzed using a gradient chromatographic separation over an ACQUITY UPLC HSS T₃ column. The mobile phase consisted of acetonitrile containing 0.2% formic acid and water containing 0.2% formic acid and gradient elution was performed at a flow rate of 0.4 mL/min. Detection was carried out on a Xevo TQ-S tandem mass spectrometer and positive electrospray ionization was employed in the multiple reaction monitoring (MRM) mode. This method was fully validated over the concentration range of 0.5-40 ng/mL with a lower limit of quantification (LLOQ) of 0.5 ng/mL. The inter- and intra-batch precision was no more than 8.8% and the accuracy was between 88.7 and 104.2%. The mean extraction recovery was 43.3% and the detection was independent of matrix. Besides, the analyte proved to be stable under various handling processes and storage conditions after acidification. Finally, the method was applied to the first-in-human (FIH) study of MLIF in Chinese healthy subjects.

100 项与广东八加一医药有限公司相关的药物交易

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100 项与广东八加一医药有限公司相关的转化医学

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