A Phase II Study of Hemospan® Versus Voluven® to Evaluate Vascular Resistance and Forearm Blood Flow, and to Assess Local Skin Blood Flow and Tissue Oxygenation in the Ischemic Foot of Patients With Chronic Critical Limb Ischemia

The purpose of this study is to evaluate the effects of Hemospan infusion on vascular reactivity, regional perfusion and oxygenation of ischemic tissue in patients with chronic critical lower limb ischemia.

开始日期2007-09-01

申办/合作机构

Sangart, Inc.

EUCTR2007-001538-15-SE / Not yet recruitingN/A

A randomized, single-blind, controlled Phase II pilot study of Hemospan® compared with colloid (Voluven®) to evaluate vascular resistance and blood flow in the forearm, and to assess local skin blood flow and tissue oxygenation in an ischemic region of the foot in patients with chronic critical limb ischemia (CCLI)

开始日期2007-06-12

申办/合作机构

Sangart, Inc.

NCT00420277 / Completed临床3期

A Randomized, Double-Blind, Phase III Study of the Efficacy and Safety of an Oxygen-Carrying Plasma Expander, Hemospan®, Compared With Voluven® toTreat Hypotension in Patients Undergoing Primary Hip Arthroplasty With Spinal Anesthesia

The purpose of this study is to determine whether Hemospan is superior to Voluven for treatment of hypotensive episodes during the perioperative period (from induction of spinal anesthesia until 6 hours after skin closure), and for reducing the incidence of operative and postoperative complications including organ dysfunction and failure until follow-up at one month following surgery. An independent Data Safety Monitoring Board (DSMB) will periodically evaluate the safety data collected during this trial

开始日期2007-02-01

申办/合作机构

Sangart, Inc.

100 项与 Human haemoglobin(Sangart) 相关的临床结果

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100 项与 Human haemoglobin(Sangart) 相关的转化医学

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100 项与 Human haemoglobin(Sangart) 相关的专利（医药）

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项与 Human haemoglobin(Sangart) 相关的文献（医药）

2024-11-01·International Journal of Biological Macromolecules

Effects of in vitro simulated digestion and fecal fermentation on the structure and regulating the glucose and lipid activity of a polysaccharide from Mori Folium

Article

作者: Wang, Ying ; Fu, Zhifei ; Zhang, Han ; Zhang, Lingyu ; Han, Lifeng ; Zhu, Tongtong ; Liu, Erwei ; Zhang, Boli

Mori folium, as a homologous drug-food, has hypoglycemic and lipid-lowering activity. Polysaccharides are the main bioactive ingredient of the Mori folium that exhibit diverse biological activities. In this study, a homogeneous polysaccharide (MP4) was purified and characterized from Mori folium. The changes of MP4 affected by saliva, simulated gastrointestinal juice, and human fecal fermentation, including physicochemical property or its bioactivity, were systematically investigated. Meanwhile, the influence of fermentation on the bioactivity were evaluated. The results showed that the backbone of MP4 is mainly composed of →4)-α-D-GalpA-(1→ residues. The molecular weight, the levels of reducing sugar content and free monosaccharides of MP4 exhibited no significant differences indicating that gastrointestinal digestion has a minimal effect on the physicochemical characteristics of MP4. However, during in vitro gut microbiota fermentation, MP4 are significantly degraded and utilized by gut microbiota, showing increased the production of short-chain fatty acids, notably acetic acid and propionic acid. The relative abundance of beneficial bacteria such as Bacteroidetes and Actinobacteria were significantly increased, whereas the levels of pathogenic bacteria such as Fusobacteria and Megamonas were significantly decreased, which changed the composition of the gut microbiota. The Firmicutes/Bacteroides ratio was also decreased significantly. Interestingly, after in vitro fermentation, the α-glucosidase inhibitory activity was increased, the lipase inhibitory activity and cholesterol adsorption activity was decreased. Correlation analysis showed that the relative abundance of some bacteria was significantly correlated with the bioactivities. These results provide a basis for the development of Mori folium polysaccharides as functional probiotic products.

2024-03-01·Food Research International

Comprehensive analysis of flavor formation mechanisms in the mechanized preparation Cantonese soy sauce koji using absolute quantitative metabolomics and microbiomics approaches

Article

作者: Zhang, Yuxiang ; Lin, Weifeng ; Li, Weixin ; Wu, Huizhen ; Lin, Jiayi ; Zhao, Chi ; Luo, Lixin

Based on the widespread application and under-research of mechanized preparation Cantonese soy sauce koji (MP), absolute quantitative approaches were utilized to systematically analyze the flavor formation mechanism in MP. The results indicated that the enzyme activities increased greatly during MP fermentation, and 4 organic acids, 15 amino acids, and 2 volatiles were identified as significantly different flavor actives. The flavor parameters of MP4 were basically identical to those of MP5. Furthermore, microorganisms were dominated by Staphylococcus, Weissella, and Aspergillus in MP, and their biomass demonstrated an increasing trend. A precise enumeration of microorganisms exposed the inaccuracy of relative quantitative data. Concurrently, Staphylococcus and Aspergillus were positively correlated with numerous enzymes and flavor compounds, and targeted strains for enhancing MP quality. The flavor formation network comprises pathways including carbohydrate metabolism, lipid metabolism and oxidation, and protein degradation and amino acid metabolism. In summary, the fermentation period of MP can be substantially shortened without compromising the product quality. These findings lay the groundwork for refining parameters in modern production processes.

2024-03-01·Heliyon

Impact of crystal polymorphism of rifaximin on dissolution behavior

Article

作者: Lassoued, Mohamed Ali ; Bahri, Senda ; Sfar, Souad ; Toukabri, Imen

IntroductionRifaximin is an intestinal antiseptic which has five (pseudo) polymorphs α, β, γ, δ and ε. These last (pseudo)polymorphs have different physicochemical properties. The objective of the study is to assess the impact of rifaximin polymorphism on its dissolution rate which could affect its bioavailability.Material and methodsThe analytical validation of dissolution assay method by UV-Visible spectrophotometry was carried out according to ICH Q2. The physicochemical characterization (solubility test, FTIR, DSC, XRD) was carried out on four active pharmaceutical ingredient (MP1, MP2, MP3, MP4). MP1 and MP2 were used by the manufacturer of generic brand 1 (G1) and MP3 and MP4 were used by the manufacturer of generic brand 2 (G2). The comparative in-vitro dissolution study was carried out on the leader brand (P), G1 and G2.ResultsThe four MPs were analyzed by XRD. The results of analysis showed that MP1 and MP4 were a mixture of α form and amorphous form. MP2 had an amorphous form and MP3 had a crystalline form β. The spectra of FTIR showed that the four MP had characteristics bands of rifaximin in the domain 4000-400 cm^-1. The differences between the spectra of the four MPs were observed among the amorphous form (MP2), around the region 1800 to 1820 cm^-1 which is attributed to the vibration of the CO group. An additional difference observed among the amorphous form (MP2) is around the region 1400 cm^-1 which is attributed to the banding OH. The thermograms of MP1, MP2 and MP4 showed endothermic peaks which are probably attributed to the departure of water which indicate that MP1, MP2 and MP4 are pseudopolymoph (hydrate). For the four MPs, probably the melting points are interrupted by the phenomenon of phase transformations (Crystallization) which are reflected by exothermic peaks around 200°C-250 °C.Our results showed that the crystalline polymorphism of rifaximin influences its solubility. According to the results of the solubility test, the β crystal form of rifaximin (MP3) had the lowest solubility (3.47 μg/ml). MP2 had the highest solubility (8.35 μg/ml) and MP1 and MP4 had intermediate solubilities (5.47 μg/ml and 6.74 μg/ml). Comparative in vitro dissolution results showed that the dissolution profile of P was not similar to that of G1 and G2 (% dissolution (P)_30min = 60%; % dissolution (G1) _30 min = 100% and % dissolution (G2) _30 min = 115%; f1(P versus G1) = 44; f1(P versus G2) = 61) in M1, while G1 and G2 had comparatively similar dissolution profiles (% dissolution (G1) _30 min = 100%; % dissolution (G1) _30 min = 110%; f1 (G1 versus G2) = 14) in M1.ConclusionThis study highlighted the impact of rifaximin polymorphism on its physico-chemical properties (crystal structure, thermal behavior, solubility) and on its dissolution behavior which could affect the rifaximin bioavailability.

100 项与 Human haemoglobin(Sangart) 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
低血压	临床3期	瑞典	Sangart, Inc.	2007-02-01
低血压	临床3期	捷克	Sangart, Inc.	2007-02-01
低血压	临床3期	波兰	Sangart, Inc.	2007-02-01
低血压	临床3期	比利时	Sangart, Inc.	2007-02-01
缺血	临床3期	比利时	Sangart, Inc.	2007-02-01
缺血	临床3期	英国	Sangart, Inc.	2007-02-01
缺血	临床3期	荷兰	Sangart, Inc.	2007-02-01
缺血	临床3期	波兰	Sangart, Inc.	2007-02-01
缺血	临床3期	瑞典	Sangart, Inc.	2007-02-01
缺血	临床3期	捷克	Sangart, Inc.	2007-02-01