人抗凝血酶Ⅲ(山东泰邦生物制品)(Human Antithrombin III(Shandong Taibang Biological Products))

概要

基本信息

药物类型

酶

别名-

靶点-

作用机制-

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构-

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)临床3期

特殊审评-

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关联

2

项与人抗凝血酶Ⅲ(山东泰邦生物制品) 相关的临床试验

CTR20232591 / Recruiting临床3期

评价人抗凝血酶Ⅲ预防先天性抗凝血酶Ⅲ缺乏症患者在高危情况下静脉血栓形成的单臂、开放、多中心临床试验

评价人抗凝血酶Ⅲ在先天性抗凝血酶Ⅲ缺乏症患者围手术期和围产期预防静脉血栓形成的有效性，为本产品申报上市提供证据。

开始日期2023-12-01

申办/合作机构

山东泰邦生物制品有限公司

CTR20180373 / Completed临床3期

人抗凝血酶Ⅲ治疗先天性抗凝血酶Ⅲ缺乏患者的药代动力学和有效性，安全性的临床试验

1）通过单次给药的PK研究，评估人抗凝血酶Ⅲ在先天性抗凝血酶Ⅲ缺陷患者中的药动学（PK）特征，观察人抗凝血酶Ⅲ在体内的恢复和半衰期； 2）观察人抗凝血酶Ⅲ治疗先天性缺乏患者的有效性和安全性。

开始日期2019-01-22

申办/合作机构

山东泰邦生物制品有限公司

100 项与人抗凝血酶Ⅲ(山东泰邦生物制品) 相关的临床结果

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100 项与人抗凝血酶Ⅲ(山东泰邦生物制品) 相关的转化医学

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100 项与人抗凝血酶Ⅲ(山东泰邦生物制品) 相关的专利（医药）

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6

项与人抗凝血酶Ⅲ(山东泰邦生物制品) 相关的文献（医药）

2016-12-01·Journal of Chromatography B3区 · 医学

Synthesis and characterisation of magnetised Dacron-heparin composite employed for antithrombin affinity purification

3区 · 医学

Article

作者: Buitrago, Davian Martinez ; de Carvalho-Júnior, Luiz Bezerra ; Silva, Ricardo de Souza ; Mercês, Aurenice Arruda Dutra das ; Maciel, Jackeline da Costa ; de Aguiar, José Albino Oliveira ; Silva, Karciano José Santos ; Oliveira, Givanildo Bezerra

Human antithrombin is a blood derivative widely used in the treatment of coagulation dysfunction. Affinity chromatography using heparin (HEP) derivatives is usually used for antithrombin purification. In this study, an affinity procedure based on a magnetic Dacron-HEP composite is proposed. Dacron was firstly converted to Dacron-hydrazide and magnetised by co-precipitation with of Fe²⁺/Fe³⁺ (mDAC). HEP was activated by carbodiimide and N-hydroxysuccinimide and covalently linked to mDAC (mDAC-HEP). EDX and infrared spectra analyses confirmed each synthesis step of mDAC-HEP. This composite exhibited superparamagnetism behaviour. Human plasma was incubated with mDAC-HEP (fresh and stored over a long period) and washed with phosphate buffer containing increasing concentrations of NaCl. Human plasma antithrombin activity was reduced by approximately 20% in the presence of the 1.0M NaCl fraction, and this eluate was able to prolong coagulation time (aPTT) using both preparations. Electrophoresis of the eluates revealed bands corresponding to the expected size of antithrombin (58kDa). The mDAC-HEP particles are reusable. This method presents the following advantages: easy, low-cost synthesis of the composite, magnet-based affinity purification steps, and reusability.

2015-02-01·The Journal of cardiovascular surgery4区 · 医学

Prophylactic intraoperative antithrombotics in open infrainguinal arterial bypass surgery: a systematic review.

4区 · 医学

Review

作者: Jongkind, V ; Vos, J ; Reijnen, M ; Wiersema, A ; Van Delden, O ; Zeebregts, C ; Moll, F ; Bruijninckx, C

Unfractionated heparin (UFH) is used intraoperatively as antithrombotic by most vascular surgeons worldwide during infrainguinal bypass surgery (IABS) to reduce the risk of peroperative and early graft thrombosis. To reduce the harmful side effects of UFH (bleeding complications, HIT) and to reduce peroperative and early graft failure, other pharmaceuticals have been suggested for IABS. A systematic review was performed using MEDLINE, EMBASE and Cochrane databases. Only 9 studies on IABS and intraoperative antithrombotic use were eligible for review. Between studies heterogeneity was high and investigated study populations were often of small size. No study was retrieved comparing UFH to no-UFH. Dextran, human antithrombin and iloprost showed no beneficial effect compared to UFH alone for patency, mortality and morbidity. Low molecular weight heparin (LMWH) has potential benefits compared to UFH, but a statistically significant effect could not be demonstrated from the current review. The use of UFH during IABS to prevent intraoperative graft thrombosis has not been proven in randomized clinical trials. Dextran, human antithrombin and iloprost showed to be of no added beneficial effect for the patient compared to UFH alone. Data on the use of LMWH instead of UFH are promising, but no statistically significant benefit could be reproduced from literature. Results from a recent Cochrane review were favourable for LMWH, but it appeared that included data were not complete in that review. Randomized controlled trials are required for intra-operative use of antithrombotics and to improve peroperative and early patency after IABS.

1988-09-01·Journal of Biological Chemistry2区 · 生物学

Human cytotoxic lymphocyte tryptase. Its purification from granules and the characterization of inhibitor and substrate specificity.

2区 · 生物学

Article

作者: H J Zweerink ; N H Sigal ; M Poe ; G P Norton ; J A Rodkey ; W E Biddison ; J T Blake ; R V Turner ; C D Bennett ; J K Wu

A trypsin-like enzyme (tryptase) has been purified to homogeneity from the granules of a human cytolytic lymphocyte (CTL) line, Q31, by a three-step procedure. By including 0.3% (v/v) Triton X-100 and 1 mg/ml heparin in purification buffers, near total yields of tryptase activity were obtained during the purification. The enzyme, referred to as Q31 tryptase, migrated in polyacrylamide gels with sodium dodecyl sulfate at a position corresponding to 28 kDa with and to 45 kDa without 2-mercaptoethanol. It had an amino-terminal sequence identical to a previously reported human CTL tryptase at 20 of 22 positions identified. It hydrolyzed N alpha-carbobenzyloxy-L-lysyl-thiobenzyl ester (BLT), and this BLT esterase activity was most efficient at slightly alkaline pH and was relatively more active near neutral pH than mouse CTL tryptase. Human alpha 1-protease inhibitor, human antithrombin III, phenylmethanesulfonyl fluoride, and p-aminobenzamidine inhibited the Q31 tryptase. The inhibition by human antithrombin III was rapid enough to be of physiological significance. A survey of oligopeptide p-nitroanilides found that the best substrate for human Q31 tryptase is H-D-(epsilon-carbobenzyloxy)Lys-L-Pro-L-Arg-p-nitroanilide. The Q31 tryptase appears to have broad specificity for amino acid residues at P2 and P3, i.e. at 2 and 3 residues amino-terminal to the scissile bond.

100 项与人抗凝血酶Ⅲ(山东泰邦生物制品) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
静脉血栓形成	临床3期	中国	山东泰邦生物制品有限公司	2023-12-01
抗凝血酶III缺乏症	临床1期	中国	山东泰邦生物制品有限公司	2021-11-19