[Discussion on the Authenticity Verification Method in the Verification of Medical Device Registration Quality Management System].

Authenticity verification is a very important aspect of medical device registration quality management system verification of medical device. How to verify the authenticity of samples is a problem worth discussing. This study analyzes the methods of authenticity verification from the aspects of product retention sample, registration inspection report, traceability of records, hardware facilities and equipment. In order to provide reference for relevant supervisors and inspectors in the verification of registration quality management system.

A novel dual-flux immunochromatographic test strip based on luminescence resonance energy transfer for simultaneous detection of ochratoxin A and deoxynivalenol.

Mycotoxins are secondary metabolites of fungi, which seriously threaten human health. Among them, ochratoxin A (OTA) and deoxynivalenol (DON) have become the main factors that pollute cereals and by-products. In order to achieve simultaneous detection of OTA and DON quantitatively, a novel dual-flux immunochromatographic assay (dICA) was established. The dual-flux assay is based on upconversion nanoparticles (UCNPs) as fluorescence tags to label antigens and gold nanoparticles (AuNPs) as fluorescence quencher to label monoclonal antibodies (mAbs). The intensity of the green fluorescence (540 nm) of UCNPs can be used as an analytical signal, indicating the formation of antigen-antibody immune complexes, thereby indicating the presence or absence of the target analyte. The intensity of the red fluorescence (660 nm) of UCNPs is not affected and can be used as a quality control signal, and the dual-flux bidirectional single-line labeling mode allows for the simultaneous detection of two different mycotoxins on two test lines. This work indicated that the developed dICA provided a sensitive, rapid, and reliable on-site simultaneous detection of multiple mycotoxins.

Correction to: CircCPA4 Promotes the Malignant Phenotypes in Glioma via miR-760/MEF2D Axis.

The article titled "CircCPA4 Promotes the Malignant Phenotypes in Glioma via miR-760/MEF2D Axis", written by Yunjuan Zhang, Zengyan Cai, Jin Liang, Erqing Chai, Anqing Lu, Yinwu Shang was originally published electronically on the publisher's internet portal (currently SpringerLink) on 17 October 2020 with open access.

CircCPA4 Promotes the Malignant Phenotypes in Glioma via miR-760/MEF2D Axis.

Circular RNA carboxypeptidase A4 (circCPA4) has been shown to involve in the tumorigenesis of glioma. However, the function and the molecular mechanism of circCPA4 in glioma remain inadequate. Levels of circCPA4 and microRNA (miR)-760 were detected by quantitative real-time polymerase chain reaction. Cell proliferation, apoptosis, migration, and invasion were analyzed using MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide), colony formation, flow cytometry, and transwell assays, respectively. Western blot was used to detect the protein levels of matrix metallopeptidase 2 (MMP2), MMP9 and myocyte enhancer factor 2D (MEF2D). The interaction between miR-760 and circCPA4 or MEF2D was analyzed by the dual-luciferase reporter assay or RNA pull-down assay. In vivo experiments were conducted using murine xenograft models. We found circCPA4 was highly expressed in glioma, and circCPA4 knockdown suppressed tumor cell proliferative, migratory and invasive behaviors, but enhanced cell apoptosis and radiosensitivity in glioma. CircCPA4 directly bound to miR-760 to suppress its expression, and miR-760 inhibition reversed circCPA4 knockdown-mediated inhibition of cell malignant phenotypes in glioma. MEF2D was a target of miR-760, and miR-760 performed anti-tumor effects by targeting MEF2D in glioma cells. Meanwhile, we found circCPA4 could indirectly regulate MEF2D by sponging miR-760. Importantly, xenograft analysis suggested that circCPA4 knockdown impeded tumor growth in vivo via regulating miR-760 and MEF2D. In conclusion, circCPA4 knockdown suppressed cell malignant phenotypes in glioma via miR-760/MEF2D axis to impede the progression of glioma, suggesting potential therapeutic targets for glioma treatment.

π-π Interactions Between Aromatic Groups in Amphiphilic Molecules: Directing Hierarchical Growth of Porous Zeolites.

The development of hierarchical macro- or mesoporous zeolites is essential in zeolite synthesis because the size of the micropores limits mass transport and their use as industrial catalysts for bulky molecules. Although major breakthroughs have been achieved, fabricating crystallographically ordered mesoporous zeolites using a templating strategy is still an unsolved challenge. This minireview highlights our recent efforts on the self-assembly of amphiphilic molecules to obtain ordered hierarchical MFI zeolites by introducing aromatic groups into the hydrophobic tail of the amphiphilic molecules. Owing to the geometric matching between the self-assembled aromatic tails and the MFI framework, a) single-crystalline mesostructured zeolite nanosheets (SCZNs), b) SCZNs with a 90° rotational intergrowth structure, c) a hierarchical MFI zeolite with a two-dimensional square P4mm mesostructure, and d) a single-crystalline mesoporous ZSM-5 with three-dimensional pores and sheetlike mesopores layered along the a-axis were successfully synthesized.

One-Pot Synthesis and Formation Mechanism of Hollow ZSM-5.

Coffin-shaped hollow ZSM-5 zeolite (HZZ) particles with shell thickness of about 200 nm and hollow diameter of approximately 1.5 µm were synthesized in one pot by using tetrapropylammonium bromide (TPABr), aluminum triisopropoxide Al[OCH(CH3 )2 ]3 and tetraethoxysilane (TEOS) as the structure-directing agent (SDA), aluminum and silica source, respectively. The appropriate molar ratios of TPABr/SiO2 and Si/Al as well as suitable crystallization temperature are the key factors for the formation of HZZ. The formation of the HZZ can be attributed to the existence of intrinsic density variation inside the initial amorphous aggregates and the Al zoning in the outer surface of the ZSM-5 particles. Amorphous silica with low crystallinity formed at early stages and low Al concentration, which has been subsequently dissolved and recrystallized on the ZSM-5 particle surface through Ostwald ripening, leading to the formation of HZZ. This approach, which uses a high concentration of SDA, will provide new possibilities and insight into the prospective fabrication of hollow zeolites.

Single-Crystalline MFI Zeolite with Sheet-Like Mesopores Layered along the a Axis.

Designing a templating strategy for directing mesopore growth along different crystallographic directions is essential for fabricating two- or three-dimensional single-crystalline mesoporous zeolites. However, so far, mesopores formed in MFI zeolites by soft templates have mostly been generated by disrupting growth along the b axis; generating mesopores by disrupting growth along the a axis is rare. Herein, a single-crystalline mesoporous MFI zeolite (SCMMZ) with sheet-like mesopores layered along the a and b axes was synthesized using a triply branched surfactant with diquaternary ammonium groups connected to 1,3,5-triphenylbenzene by a six- and eight-carbon alkyl chain (TPB-6 and 8). The sheet-like mesopores were embedded in the MFI framework and were retained even after calcination. Molecular mechanics calculations provided evidence of low binding energy configurations of the surfactant that directed the growth of straight and zigzag channels along the b and a axes, respectively. The formation of nanosheets was attributed to the geometric matching of the arrangement of the aromatic groups to the zeolite framework.

Effects of purulent meningitis on the changes of matrix metalloproteinase-2 (MMP-2) and matrix metalloproteinase inhibitor-1 (TIMP-1) in cerebrospinal fluid of neonates.

This study was aimed to investigate the changes of matrix metalloproteinase-2 (MMP-2) and matrix metalloproteinase inhibitor-1 (TIMP-1) in cerebrospinal fluid (CSF) of neonates with purulent meningitis. 195 cases (n=195) were divided into PM group (neonatal purulent meningitis), VM group (neonatal virus meningitis) and control group (healthy neonates). The expression levels of MMP-2 and TIMP-1 were detected by ELISA while the level of PCT was determined by chemiluminescence analyzer. The levels of MMP-2 and TIMP-1 in CSF and PCT in serum were compared in three groups and the correlation was discussed. The level of MMP-2 in CSF in 3 groups were statistically significant (F=16.126, P<0.05) similarly the level of TIMP-1 in CSF of 3 groups were statistically significant (F=16.093, P<0.05). The serum level of PCT in PM group was 14.73±2.14ng/l, in VM group was 9.06±1.05ng/l and in control group it was 0.37±0.12ng/l. The levels of MMP-2 and TIMP-1 in CSF were positively correlated with the serum level of PCT in both PM and VM group. The expression of MMP-2, TIMP-1 and serum PCT in CSF of newborns with purulent meningitis was increased. The findings suggest that MMP-2, TIMP-1 and PCT are involved in the occurrence and development of neonatal purulent meningitis.

Hierarchical MFI Zeolites with a Single-Crystalline Sponge-Like Mesostructure.

Single-crystalline sponge-like MFI mesoporous zeolites (SSMZs) have been synthesized by using bolaform surfactants with an axial chiral binaphthyl core in the hydrophobic tail and triquaternary ammonium head groups, as bifunctional organic structure-directing agents (OSDAs). By changing the length of alkyl chain between a triquaternary ammonium head group and a binaphthyl group from 4 to 10 carbons, SSMZs with high specific surface area (382-434 m2 g-1 ), abundant micropore-mesopore connectivity, and uniform mesopore diameter (4-10 nm) were obtained. OSDAs with an alkyl chain length of 11 and 12 carbons led to the formation of nanorod-constructed mesoporous MFI zeolites. A geometrical matching between the cylindrical arrangement of the binaphthyl groups and the zeolitic framework is speculated to be the key factor for the formation of mesoporous zeolites. The SSMZ zeolites, with abundant mesopores beneficial for the diffusion of reactants, exhibited significantly higher catalytic efficiencies than those of the conventional ZSM-5 with a microcrystal morphology (≈1.5 µm).

[Discussion on the Existing Problems and Countermeasures of Medical Devices (â ¡) Clinical Trial].

To provide reference for further improve the level of medical devices clinical trial, to ensure the medical devices quality combing with the problems found in the medical devices clinical trial in Shandong province, the problems and countermeasures of medical devices (Ⅱ) clinical trial were explored. Four countermeasures were put forward to solve the problems of medical devices (Ⅱ) clinical trial from different angles including sponsors, clinical trials institutions and the important part of clinical trials:raising the threshold of entry, consummating relevant laws and regulations, establishing quality management system, strengthening personnel training, attaching great importance to CRA and CRC.

N, S-Doped Carbon Dots Prepared by Peanut Protein Isolates and Cysteamine as Highly Sensitive Fluorescent Sensors for Fe2+, Fe3+ and Lactoferrin.

Lactoferrin (LF) is an iron-binding glycoprotein with various biological activities that has been extensively used in food and medical applications. Several methods for detecting LF have been reported, but they still face challenges in terms of sensitivity and simplicity of detection. To achieve an accurate and efficient detection of LF, we developed a method for the determination of LF in lactoferrin supplements using carbon dots (CDs) fluorescent probes. The N, S-doped PPI carbon dots (N, S-PPI-CDs) were prepared using a protein (peanut protein isolate) and cysteamine as precursors. The prepared N, S-PPI-CDs exhibited intense blue fluorescence and good biocompatibility, while the fluorescence intensity of the N, S-PPI-CDs showed a good linear relationship with Fe2+/Fe3+ concentration (0-2 µM). The N, S-PPI-CDs exhibited a high potential ability to rapidly detect Fe2+/Fe3+ within 30 s, with a limit of detection (LoD) of 0.21 µM/0.17 µM. Due to the reversible binding of LF to Fe, the N, S-PPI-CDs showed a high sensitivity and selectivity for LF, with a limit of detection (LoD) of 1.92 µg/mL. In addition, LF was quantified in real sample LF supplements and showed a fluctuation in recovery of less than 2.48%, further demonstrating the effectiveness of the fluorescent N, S-PPI-CDs sensor.

Short-Chain Fatty Acids Produced by Ruminococcaceae Mediate α-Linolenic Acid Promote Intestinal Stem Cells Proliferation.

SCOPE: The proliferation and differentiation of intestinal stem cells (ISCs) are the basis of intestinal renewal and regeneration, and gut microbiota plays an important role in it. Dietary nutrition has the effect of regulating the activity of ISCs; however, the regulation effect of α-linolenic acid (ALA) has seldom been reported. METHODS AND RESULTS: After intervening mice with different doses of ALA for 30 days, it is found that ALA (0.5 g kg-1 ) promotes small intestinal and villus growth by activating the Wnt/ß-catenin signaling pathway to stimulate the proliferation of ISCs. Furthermore, ALA administration increases the abundance of the Ruminococcaceae and Prevotellaceae, and promotes the production of short-chain fatty acids (SCFAs). Subsequent fecal transplantation and antibiotic experiments demonstrate that ALA on the proliferation of ISCs are gut microbiota dependent, among them, the functional microorganism may be derived from Ruminococcaceae. Administration of isobutyrate shows a similar effect to ALA in terms of promoting ISCs proliferation. Furthermore, ALA mitigates 5-fluorouracil-induced intestinal mucosal damage by promoting ISCs proliferation. CONCLUSION: These results indicate that SCFAs produced by Ruminococcaceae mediate ALA promote ISCs proliferation by activating the Wnt/ß-catenin signaling pathway, and suggest the possibility of ALA as a prebiotic agent for the prevention and treatment of intestinal mucositis.

Increased antioxidant activity and improved structural characterization of sulfuric acid-treated stepwise degraded polysaccharides from Pholiota nameko PN-01.

The aim of this study was to investigate sulfuric acid degradation of the Pholiota nameko polysaccharide (AIPS-1). Three stepwise degraded polysaccharides (AIPS-2, AIPS-3, and AIPS-4) were obtained by sequentially increasing the strength of sulfuric acid treatment. Structural characterization showed that sulfuric acid treatment significantly decreased molecular weight, increased the content of uronic acid and changed the molar ratio of monosaccharide composition, while the major functional groups and the triple helical conformation of polysaccharides did not change significantly. In vitro experiments proved that the antioxidation ability of the stepwise degraded polysaccharides gradually increased (AIPS-1 < AIPS-2 < AIPS-3 < AIPS-4). An oxidative stress zebrafish model was established, which demonstrated that the ability of AIPS-3 and AIPS-4 to scavenge free radicals in zebrafish was significantly improved compared to AIPS-1. In conclusion, sulfuric acid treatment is an effective method for improving the antioxidant activity of polysaccharides, and increased antioxidant activity was closely related to the changes in their structural characteristics.

Polyphenol Extract of Moringa Oleifera Leaves Alleviates Colonic Inflammation in Dextran Sulfate Sodium-Treated Mice.

Moringa oleifera Lam. is an essential herb used for the treatment of inflammation, diabetes, high blood pressure, and other diseases. In this study, phenolic extracts of M. oleifera leaves were obtained and analyzed. The results showed that the main identifiable phenols were astragalin, chlorogenic acid, isoquercitrin, kaempferitrin, luteolin, quercetin, and rutin. The effects of M. oleifera polyphenol extract (MOPE) on experimental colitis induced by 3% dextran sulfate sodium (DSS) were investigated. The results showed that oral administration of MOPE significantly alleviated the symptoms of DSS-induced colitis. MOPE significantly reduced weight loss, the disease activity index, colon shortening, and mucosal damage. In addition, MOPE attenuated the infiltration of CD3+ T cells, CD177+ neutrophils, and F4/80+ macrophages and significantly inhibited the secretion of IL-6 and TNF-α. After the MOPE administration, the expression of proteins associated with the NF-κB signaling pathway changed. Specifically, compared with that of the DSS group, the protein expression of NF-κB p65 and p-IκBα was downregulated, and the expression of IκBα was upregulated. This study revealed the anti-inflammatory effects and mechanisms of MOPE in the colon, indicating its potential use in preventing inflammation-driven diseases.

Distribution of Zinc in Mycelial Cells and Antioxidant and Anti-Inflammatory Activities of Mycelia Zinc Polysaccharides from Thelephora ganbajun TG-01.

This study demonstrates that Thelephora ganbajun had a strong ability to absorb zinc, and zinc can be compartmentally stored in the small vesicles and mainly accumulated in the form of zinc-enriched polysaccharides (zinc content was 25.0 ± 1.27 mg/g). Mycelia zinc polysaccharides (MZPS) and its fractions were isolated. The main fraction (MZPS-2) with the highest antioxidant activity in vitro was composed of mannose : galacturonic acid : glucose : galactose in a molar ratio of 61.19 : 1 : 39.67 : 48.67, with a weight-averaged molecular weight of 5.118 × 105 Da. MZPS-2 had both α-pyranose and ß-pyranose configuration and had a triple helical conformation. By establishing zebrafish models, we found that MZPS-2 can significantly scavenge free radicals, reduce the generation of reactive oxygen species caused by inflammation, and inhibit the recruitment of neutrophils toward the injury site. Therefore, MZPS-2 exhibited antioxidant and anti-inflammatory effects and can be used as a zinc supplement with specific biological activities to alleviate zinc deficiency complications, such as chronic oxidative stress or inflammation.

Synthesis of hierarchical MFI zeolites with a micro-macroporous core@mesoporous shell structure.

Core-shell structured ZSM-5 zeolites (CSSZs) consisting of a micro-macroporous zeolite core and a mesoporous zeolite shell were synthesized by using a bifunctional surfactant containing an alkene group in the hydrophobic tail. The alkene tail and aluminum concentration are the key factors for the formation of the mesoporous shell in CSSZs.

Epigallocatechin-3-gallate induces the apoptosis of hepatocellular carcinoma LM6 cells but not non-cancerous liver cells.

Epigallocatechin-3-gallate (EGCG) is a constituent of green tea and has been associated with anticancer activity. In the present study, the inhibitory effect of EGCG on human hepatocellular cancer cells was examined by cell viability assay, in vitro apoptosis assay and cell cycle analysis. In addition, gene expression was measured to elucidate the molecular mechanisms of action of EGCG by mitochondrial membrane potential (MMP) determination and western blot analysis. We demonstrated that EGCG induced apoptosis, decreased mitochondrial membrane potential and promoted G0/G1 phase cell cycle arrest of HCCLM6 cells but not that of non-cancerous liver cells (HL-7702). The EGCG-induced apoptosis of HCCLM6 cells was associated with a significant decrease in Bcl-2 and NF-κB expression. In addition, the expression of Bax, p53, caspase-9 and caspase-3 increased, and cytochrome c was released. These results suggest that EGCG inhibits the progression of cancer through cytocidal activity and that it is a potential therapeutic compound for hepatocellular carcinoma (HCC).

Anti-metastatic and differential effects on protein expression of epigallocatechin-3-gallate in HCCLM6 hepatocellular carcinoma cells.

Hepatocellular carcinoma (HCC) is the fifth most common cancer worldwide and the third highest cause of cancer-related mortality in humans. Epigallocatechin-3-gallate (EGCG) has been shown to inhibit the metastatic activity of certain cancer cells. The aim of this study was to determine the effects and molecular mechanism(s) of action of EGCG in human HCC cells. A migration and invasion assay for the metastatic behavior of HCCLM6 cells was performed. The anti-metastatic effects of EGCG were investigated by RT-PCR and gelatin zymography. A total cellular protein profile was obtained using 2-dimensional gel electrophoresis (2-DE), followed by matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF-MS) analyses of proteins with significant differences in expression following treatment with EGCG. The results revealed that EGCG induced apoptosis and inhibited the metastasis of HCCLM6 cells. The anti-metastatic effects of EGCG were associated with the inhibition of matrix metalloproteinase (MMP)-2 and MMP-9 activity. The expression levels of far upstream element (FUSE) binding protein 1 (FUBP1), heat shock protein beta 1 (HSPB1), heat shock 60 kDa protein 1 (chaperonin) (CH60) and nucleophosmin (NPM) proteins, which are associated with metastasis, were significantly altered in the EGCG-treated HCCLM6 cells. The data from the present study suggest that EGCG has potential as a therapeutic agent for the treatment of HCC.

GRP78 and GAL3, differentially regulated by lymph node homogenates, as potential biomarkers for lymph node metastasis in mouse hepatocellular carcinoma cells.

In order to systematically evaluate the influence of lymph nodes (LNs) in lymph node metastases (LNM) of hepatocellular carcinoma (HCC), we set up a new in vitro model in which Hca-F and Hca-P cells were cultured in medium containing lymph node homogenates (LNHs). Differential protein expression was measured by two-dimensional gel electrophoresis (2-DE) combined with matrix-assisted laser desorption/ionization time-of-flight/time-of-flight mass spectrometry (MALDI TOF/TOF MS). Results from protein identification revealed two metastatic correlative proteins, 78-kDa glucose-regulated protein (GRP78) and galectin-3 (GAL3). Western blotting confirmed that GRP78, a protein positively correlated with metastasis, increased 2.4-fold in Hca-F cells but decreased to almost a half in Hca-P cells (P<0.05). However, GAL3, a protein negatively correlated with metastasis, was decreased by a half in Hca-F cells but slightly increased non-significantly in Hca-P cells. Thus, our results reveal that some components of LNHs may facilitate a permissive environment for cancer cells with high metastasis potential to eventually metastasize. GRP78 and GAL3 may serve as potential biomarkers for the diagnosis of LNM in HCC.