Shandong Quality Inspection Center for Medical Devices

Jinan, China

Shandong Quality Inspection Center for Medical Devices

Jinan, China
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Hu L.-X.,Huazhong University of Science and Technology | He J.,Huazhong University of Science and Technology | He J.,Central Hospital of Wuhan | Hou L.,Shandong Quality Inspection Center for Medical Devices | And 7 more authors.
PLoS ONE | Year: 2013

Devices and materials intended for clinical applications as medical and implant devices should be evaluated to determine their biocompatibility in physiological systems. This article presents results from cytotoxicity assay of L929 mouse fibroblasts culture, tests for skin irritation, intracutaneous reactivity and sensitization, and material implantation tests for the novel copper/low-density polyethylene nanocomposite intrauterine device (nano-Cu/LDPE IUD) with potential for future clinical utilization. Cytotoxicity test in vitro was conducted to evaluate the change in morphology, growth and proliferation of cultured L929 mouse fibroblasts, which in vivo examination for skin irritation (n = 6) and intracutaneous reactivity (n = 6) were carried out to explore the irritant behavior in New Zealand White rabbits. Skin sensitization was implemented to evaluate the potential skin sensitizing in Hartley guinea pigs (n = 35). The materials were implanted into the spinal muscle of rabbits (n = 9). The cytotoxicity grade of the nano-Cu/LDPE IUD was 0-1, suggested that the composite was nontoxic or mildly cytotoxic; no irritation reaction and skin sensitization were identified in any animals of specific extracts prepared from the material under test; similarly to the control sides, the inflammatory reaction was observed in the rabbits living tissue of the implanted material in intramuscular implantation assay. They indicated that the novel composite intrauterine device presented potential for this type of application because they meet the requirements of the standard practices recommended for evaluating the biological reactivity. The nano-Cu/LDPE IUD has good biocompatibility, which is biologically safe for the clinical research as a novel contraceptive device. © 2013 Hu et al.


PubMed | Tohoku University, Shandong Quality Inspection Center for Medical Devices and Shanghai JiaoTong University
Type: Journal Article | Journal: Journal of materials science. Materials in medicine | Year: 2016

Zein porous scaffolds modified with fatty acids have shown great improvement in mechanical properties and good cell compatibility in vitro, indicating the potential application as a bone tissue engineering substitute. The present study was conducted to systematically investigate whether the addition of fatty acids affects the short-term (up to 12 weeks) and long-term (up to 1 year) behaviors of scaffolds in vivo, mainly focusing on changes in the degradation period and inflammatory responses. Throughout the implantation period, no abnormal signs occurred and zein porous scaffolds modified with oleic acid showed good tolerance in rabbits, characterized by the growth of relatively more blood vessels in the scaffolds and only a slight degree of fibrosis histology. Moreover, the degradation period was prolonged from 8 months to 1 year as compared to the control. These results affirmed further that zein could be used as a new kind of natural biomaterial suitable for bone tissue engineering.


Chenghu L.,Shandong Quality Inspection Center for Medical Devices
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation | Year: 2010

To improve our comprehensions to complement activation by biomaterial and lay the foundation for biosafety evaluation of solid biomaterials together with the corresponding blood contacting medical devices. Analyzed new requirements of current standards on complement activation by solid biomaterial as well as the mechanism of complement activation by solid biomaterial and how to select the related standards for inspection. The new edition of international standards has enhanced types of blood contacting medical devices which are appropriate to complement activation test. It is badly in need of establishing the corresponding industry standards to regulate these requirements, since there have no uniform and admissive methods for inspection of complement activation by solid biomaterial.


Liang W.,Nanjing University | Han Q.,CAS Institute of Genetics and Developmental Biology | Han Q.,University of Chinese Academy of Sciences | Jin W.,Nanjing University | And 7 more authors.
Biomaterials | Year: 2010

Spinal cord crushed injury is clinically common. Promoting targeted neural regeneration at the crushed site of spinal cord could be important for the repair. It has been demonstrated in our previous work that native human BDNF fused with a collagen-binding domain (CBD-BDNF) can bind to collagen specifically to exert the neurotrophic effect on promoting axonal regeneration. After injury, collagen is highly accumulated at the injury site. We thus speculate that CBD-BDNF will bind to the extracellular matrix collagen and concentrate at the injury site to improve the therapy. Using the rat spinal cord crushed injury model, we have found that CBD-BDNF by one-time intrathecally injection could be retained and concentrated at the injury site for a longer time than native BDNF without collagen-binding domain. CBD-BDNF could promote better neural regeneration and locomotion recovery. © 2010 Elsevier Ltd.


Liu Z.,Shandong University | Qiu S.,Shandong University | Qiu S.,Shandong Quality Inspection Center for Medical Devices | Hou L.,Shandong Quality Inspection Center for Medical Devices | And 6 more authors.
International Immunopharmacology | Year: 2013

Polysorbate 80 (Tween® 80) is the most extensively used surfactant in parenteral drug formulation. Its application as an adjunct for intravenous drug administration is approved by the Food and Drug Administration. However, severe hypersensitive reactions, which are typical non-immune anaphylactic reactions (pseudoallergy) characterized by the release of histamine and unvaried IgE antibodies, have been associated with Tween® 80. In order to explore the non-immune anaphylactic mechanisms of Tween® 80, we performed in vivo experiments to assess the changes in physiological and hematologic indicators after intravenous injection of Tween® 80 into dogs. Tween® 80 induced the release of histamine, and a 2-fold increase in SC5b-9, 2.5-fold increase in C4d, 1.3-fold increase in Bb, while IgE remained unchanged. It also produced changes in pulmonary pressure, systemic pressure and ECG. In in vitro experiments, Tween® 80 was incubated with dog serum in the presence of an inhibitor of complement activation (EGTA/Mg2+). Under these conditions, Tween® 80 increased the contents of C4d and Bb. The results of this study reveal that Tween® 80 can cause cardiopulmonary distress in dogs and activate the complement system through classical and alternative pathways as indicated in both in vivo and in vitro preparations. Moreover, they demonstrate the utility of the beagle dog as an animal model for the study of complement activation-related pseudoallergy. These findings raise concerns with regard to the indiscriminate use of Tween® 80 in clinical applications. © 2012 Elsevier B.V. All rights reserved.


Han Q.Q.,CAS Institute of Genetics and Developmental Biology | Han Q.Q.,University of Chinese Academy of Sciences | Jin W.,Nanjing University | Xiao Z.F.,CAS Institute of Genetics and Developmental Biology | And 7 more authors.
Biomaterials | Year: 2011

Brain derived neurotrophic factor (BDNF) has been shown to ameliorate recovery after intracerebral hemorrhage (ICH). The injured brain tissue after ICH is surrounded by hematoma formed from hemorrhage. Fibrin is abundant in hematoma, which could be a binding target for BDNF. In this work, we have fused a fibrin-binding domain (FBD) to BDNF (FBD-BDNF), and results demonstrate that FBD-BDNF has specific binding ability to fibrin and is retained in hematoma. Using the rat ICH model induced by bacterial collagenase, injected FBD-BDNF has been concentrated and retained at the hematoma. FBD has facilitated BDNF to exert targeting neuroprotective effect to the injured brain tissue around the hematoma after ICH. FBD-BDNF has significantly reduced the hemotoma volume, reduced tissue loss, promoted neural regeneration, and improved the rat behavioral performance. © 2011 Elsevier Ltd.


Han Q.,CAS Institute of Genetics and Developmental Biology | Han Q.,University of Chinese Academy of Sciences | Li B.,Chongqing Medical University | Feng H.,Chongqing Medical University | And 5 more authors.
Biomaterials | Year: 2011

Brain-derived neurotrophic factor (BDNF) has been shown to have therapeutic effects on cerebral ischemia. However, the delivery approach limits its application. Laminin is a rich extra cellular matrix in the central nervous system, and is highly expressed in the ischemic region after cerebral ischemia. We reported here by fusing with laminin-binding domain (LBD) to BDNF to construct laminin-binding BDNF (LBD-BDNF). LBD-BDNF could target accumulated laminin in the ischemic region and exert targeting therapy of injured neurons after ischemia. We examined the laminin-binding ability and neurotrophic bioactivity of LBD-BDNF in vitro, and assessed its targeting therapy using a rat permanent middle cerebral artery occlusion (MCAO) model in vivo. It was found that LBD-BDNF could specifically bind to laminin and maintain BDNF activity both in vitro and in vivo. LBD-BDNF treatment attenuated neural-degeneration after MCAO, and also resulted in a reduction of infarct volume that is associated with a parallel improvement in neurological functional outcome and neurogenesis in the dentate gyrus of hippocamp. © 2011 Elsevier Ltd.


Yue M.,Shandong University | Zhang M.,Shandong University | Liu B.,Shandong Quality Inspection Center for Medical Devices | Xu X.,Shandong University | And 3 more authors.
Chinese Journal of Chemical Engineering | Year: 2013

Modified peanut shell (MPS) was prepared by amination reaction with peanut shell (PS) as the starting material. The sorption of Cr(VI) oxyanions on MPS in static and column tests were investigated. In addition, the sorption isotherm and kinetic models were applied to confirm the sorption capacity and the sorption mechanisms. BET surface area analysis showed the physicochemical characteristics of the samples. The results of zeta potential, Fourier transform infrared (FT-IR) and Raman spectra analysis illustrated that chemical adsorption and ion exchange are the potential sorption mechanism. The static sorption test showed that the maximum sorption capacity (qmax) of MPS for Cr(VI) increased with temperature, which indicated that the Cr(VI) sorption process was endothermic. The saturated sorption capacity of Cr(VI) in the column sorption test was 138.34 mg·g-1, which accounted for 93.9% of the qmax at 25°C. The regeneration capacity of MPS was evaluated using HCl solution as an eluent. The high regeneration efficiency (82.6%) validated the dominance of the ion exchange mechanism in the Cr(VI) sorption process with Cl- ions displacing Cr(VI) oxyanion on MPS. The Langmuir isotherm model showed a higher correlation coefficient than the other adsorption isotherm models. And in the kinetic study, a pseudo-second-order model fit the data best. © 2013 Chemical Industry and Engineering Society of China (CIESC) and Chemical Industry Press (CIP).


PubMed | Shandong Quality Inspection Center For Medical Devices
Type: | Journal: Methods in molecular biology (Clifton, N.J.) | Year: 2015

As an oncogene, over-activated signal transducer and activator of transcription 3 (STAT3) has been detected in many tumors. STAT3 controls cell differentiation, proliferation, and survival, and is associated with angiogenesis and immune dysfunction during tumorigenesis. Double-stranded decoy oligodeoxynucleotide (ODN) targeting over-activated STAT3 in tumor cells have shown significant antitumor efficiency. Here, we describe the materials and methods involved in STAT3 decoy ODN therapy for cancer including both the antitumor effect directly and immunotherapy indirectly.


PubMed | Shandong Medical Imaging Research Institute, Shandong Quality Inspection Center for Medical Devices and Shandong University
Type: | Journal: Journal of pediatric surgery | Year: 2017

MiR-21 is one of the most often found miRNAs overexpressed in solid tumors, while PTEN is the most highly mutated tumor suppressor gene. Our purpose was to examine the expression levels of miR-21 and PTEN protein in Wilms tumor (WT) and in para-tumoral tissues and to investigate the relationships among miR-21, PTEN expression, clinicopathological parameters and the prognosis of patients with WT.The expression levels of miR-21 and PTEN protein in WT and corresponding para-tumoral tissues were investigated by qRT-PCR and Western blot, respectively. Differences in patient survival were determined using the Kaplan-Meier method and the log-rank test. A Cox proportional hazards regression analysis was used for univariate and multivariate analyses of prognostic values.Compared with para-tumoral renal tissues, the expression levels of miR-21 were significantly upregulated in WT tissues, while the PTEN protein were significantly downregulated (P<0.05). Analyses of the clinicopathological parameters showed that the miR-21 expression level was significantly associated with age, late clinical stage, histopathological tumor type and lymphatic metastasis (P<0.05). PTEN protein expression was significantly associated with age, late clinical stage and histopathological tumor type (P<0.05). The univariate linear regression analysis illustrated a significant negative correlation between miR-21 and PTEN expression (r=-0.687, P<0.05). The Kaplan-Meier curve showed that patients with high miR-21 and low PTEN protein expression survived significantly longer (P<0.05). However, a multivariate analysis suggested that neither the expression level of miR-21 nor that of PTEN is an independent prognostic factor for overall survival.Both upregulated miR-21 and downregulated PTEN expression have a possible correlation with the aggressive progression and poor prognosis of WT, which suggests that upregulated miR-21 and downregulated PTEN expression may be valuable markers of tumor progression and indicators of the prognosis of WT.

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