Open Randomized Study of the Safety, Tolerability, and Pharmacokinetic Parameters of UNIFUZOL® (Solution for Infusions, 1.4%, Manufactured by "NTFF"POLYSAN " Ltd.,Russia) in Healthy Volunteers at Different Rates of Administration (Phase I)

Unifusol (R) is a solution of arginine sodium succinate for intravenous infusions. Its effects include vasodilation, protection of inner layer of blood vessels and improvement of blood viscosity. The present phase I study is aimed to evaluate the safety and tolerability of Unifusol infusions in healthy volunteers.

开始日期2016-07-15

申办/合作机构

POLYSAN Scientific & Technological Pharmaceutical Company

100 项与 Arginine sodium succinate 相关的临床结果

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100 项与 Arginine sodium succinate 相关的转化医学

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100 项与 Arginine sodium succinate 相关的专利（医药）

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项与 Arginine sodium succinate 相关的文献（医药）

2023-01-01·Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova

[Study of the effect of Unifuzol on cognitive impairment and damage to the hippocampus and cerebral cortex during course administration to rats with bilateral stenosis of the common carotid arteries, causing chronic circulatory failure].

Article

作者: Kovalenko, A L ; Lycheva, N A ; Kuznetsova, E V ; Myagkova, I A ; Morkovin, E I ; Kurkin, D V ; Shmidt, M V ; Bakulin, D A ; Robertus, A I ; Tarasov, A S

OBJECTIVETo study the effect of Unifuzol (L-arginine sodium succinate) on cognitive impairment, cerebral blood flow, and damage to the tissues of the hippocampus and cerebral cortex during a 10-day course of administration to rats with chronic cerebral ischemia (CCI) caused by bilateral stenosis of the common carotid arteries (CCA).MATERIAL AND METHODSThe study was conducted on male rats with CCI caused by bilateral stenosis of the CCA by 60%. 40 days after surgery, rats received Unifusol (21, 42 and 84 ml/kg), nicergoline (10 mg/kg), citicoline (500 mg/kg) or placebo (0.9% NaCl) for 10 days. Next, cognitive impairments were assessed in the Morris Water Maze and the New Object Recognition (NOR) test, as well as the level of motor and exploratory activity in the Open Field test. The level of cerebral blood flow was determined immediately after the CCA stenosis and at the end of the experiment. Animals were euthanized in a CO₂ incubator, after which the brain was removed and subjected to morphometric analysis.RESULTSIn animals that were modeled with CCA stenosis, pronounced behavioral and cognitive impairments occurred as a result of a decrease in blood flow in the vessels of the brain and subsequent changes in the tissues of the hippocampus and the cerebral cortex. Intravenous course administration of Unifuzol at doses of 42 and 84 ml/kg to animals with CCI was comparable in efficiency to nicergoline and citicoline, which was expressed in greater preservation of the cognitive abilities of animals in the Morris Water Maze and NOR tests. In the Open Field test, animals injected with Unifusol at doses of 42 and 84 ml/kg performed more acts of motor and exploratory activity than animals from the placebo group, and had a higher level of cerebral blood flow (compared to animals that were injected with citicoline). Based on the results of a morphological study, it was found that the most significant neuroprotective effect was provided by nicergoline and Unifuzol (at doses of 42 and 84 ml/kg).CONCLUSIONUnifuzol at a course of administration at doses of 42 and 84 ml/kg, comparable to the reference drugs nicergoline and citicoline, reduces the severity of psychoneurological deficit in animals with CCI, comparable to them improves the microcirculation of brain tissues, preventing damage to brain tissues.

2021-05-01·Journal of Pharmaceutical Sciences3区 · 医学

The Influence of Arginine and Counter-Ions: Antibody Stability during Freeze-Drying

3区 · 医学

Article

作者: Fissore, Davide ; Bregolin, Alessandro ; Friess, Wolfgang ; Seifert, Ivonne

Amino acids, for example L-arginine, are used in lyophilisation as crystalline bulking, buffering, viscosity reducing or stabilising excipients. In this study, arginine was formulated with different counter ions (hydrochloride, citrate, lactobionate, phosphate, and succinate). A monoclonal antibody was investigated in sugar-free arginine formulations and mixtures with sucrose regarding cake appearance and protein aggregation and fragmentation. Arginine hydrochloride formulations collapsed during lyophilisation due to its low Tg' and partially crystallised during storage, but provided the best protein stability at low antibody concentration, followed by arginine succinate. Arginine citrate/phosphate/lactobionate formulations resulted in amorphous elegant cakes, but inferior protein stability. Addition of sucrose improved cake appearance and protein stability. Arginine phosphate with sucrose resulted in similar protein stability as the sucrose reference. Mixtures of sucrose with arginine hydrochloride/lactobionate/succinate provided better stability than sucrose alone. While 50 mg/mL antibody improved the cake appearance, only arginine lactobionate provided sufficient protein stability next to sucrose. Overall, sugar-free arginine hydrochloride and lactobionate lyophilisates stabilised the antibody comparably or better than sucrose depending on antibody concentration. The best protein stability was found for mixtures of arginine hydrochloride/lactobionate/succinate with sucrose.

1997-01-01·Yao xue xue bao = Acta pharmaceutica Sinica

[Influence of intracerebroventricular injection of sodium nitroprusside L-arginine and NG-nitro-L-arginine on cardiovascular activity in conscious rats].

Article

作者: Qiu, Y ; Liu, Y L ; Qiu, X C ; Li, C X

In order to study the cardiovascular effect of NO in conscious rats, sodium nitroprusside (SNP), the precursor of NO (L-Arginine, Arg-Arg) and one of the inhibitor of NOS (NG-nitro-L-arginine, NNLA) were intracerebroventricularly (icv) injected. Our experimental results indicated that, an apparent dose-dependent hypertensive effect was produced by icv administration of SNP (8, 16, 32 and 32 micrograms), a tachycardiac effect was also produced at the same time. In addition, hypertension and tachycardia were produced by icv L-arginine and the dipeptide Arg-Arg. Furthermore a hypotensive and bradycardiac effect can be produced by icv NNLA. These results suggest that there is a positive effect on cardiovascular activity due to increase of endogeneuse NO in the rat brain and a negative effect on cardiovascular activity due to decrease of endogeneuse NO in the rat brain.

100 项与 Arginine sodium succinate 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Arginine sodium succinate	-	-

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
外周血管疾病	临床1期	-	Polysan Ltd.	-
外周血管疾病	临床1期	-	Ecopharm Patent Management AG	-
中毒	临床1期	-	Ecopharm Patent Management AG	-
中毒	临床1期	-	Polysan Ltd.	-