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Chen L.,National Institute for Food and Drug Control
Sheng wu yi xue gong cheng xue za zhi = Journal of biomedical engineering = Shengwu yixue gongchengxue zazhi | Year: 2013

The rat abdominal wall defect and cecal abrasion model was adopted in this study to investigate the anti-adhesion effect of different formulated sodium hyaluronate membranes. Both injured surfaces of abdominal wall and cecum in experiment groups A, B, and C were covered using the corresponding formulated membrane A (composed of sodium hyaluronate and chitosan), membrane B (sodium hyaluronate), and membrane C (composed of sodium hyaluronate and carboxymethyl chitosan), respectively. And no material was used in the surgical as control group. Seven days after the surgery, the grade and score of abdominal adhesion of rats were evaluated according to Phillips' and Nair's classification methods respectively. Then tissue samples were collected and prepared for histological examination. The rank sum tests of scores of adhesion between groups were carried out. It showed that there was no significant difference of adhesion scores among experimental group A and control group (P > 0.05). But the differences were statistically significant (P < 0.01) among group B or C and control group, which indicated the anti-adhesive effect of B formulation and C formulation sodium hyaluronate membranes. The histological examination showed in group A that there was heavy inflammatory cell invasion and necrosis in the newly formed adhesive fibrous tissue, especially in the zone of remaining membrane A. Normal injury healing process was observed in rat abdominal wall and cecal surface covered using membrane B or C. The A formulation sodium hyaluronate membrane had poor biocompatibility which resulted in no anti-adhesion effect. The prevention of adhesion formation by B formulation and C formulation sodium hyaluronate membranes were confirmed in this experiment and would be worthy of further exploitation. Source


Zhang X.,National Institute for Food and Drug Control
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation | Year: 2014

The paper introduces supervision situation of enterprises of medical devices from the aspects of supervision team of medical devices, construction of credit system and implementation of regulation of quality management of medical devices, and raises supervision difficulties and puts forwards corresponding proposals. Source


Sun J.,University of Macau | Sun J.,National Institute for Food and Drug Control | Bi C.,University of Macau | Chan H.M.,University of Macau | And 3 more authors.
Colloids and Surfaces B: Biointerfaces | Year: 2013

Purpose: The aim of the present study was to blend liquid lipids with solid lipids to encapsulate curcumin in solid lipid nanoparticles (SLNs), thereby improving the dispersibility and chemical stability of curcumin, prolonging its antitumour activity and cellular uptake and enhancing its bioavailability. Methods: Curcumin-loaded SLNs (C-SLNs) were prepared by high-pressure homogenisation with liquid lipid Sefsol-218®. The morphology, stability and release of curcumin in the optimised formulation were investigated. The anti-cancer activity of the formulation was evaluated in MCF-7 cells. Fluorescence spectrophotometry was used to quantify cellular uptake of the drug. The pharmacokinetic profiles of curcumin in SLNs after intravenous administration were studied in rats. Results: Blending Sefsol-218® into a lipid matrix reduced the particle size without improving drug loading. An optimised formulation consisting of Dynasan 114®, Sefsol-218®, and Pluronic F68® (630:70:300, w/w) loaded with 0.8% drug was prepared. This formulation could be dispersed in water with a mean particle size of 152.8±4.7nm and a 90% entrapment efficiency. Curcumin displayed a two-phase sustained release profile from C-SLNs with improved chemical stability. Compared to the solubilised solution, C-SLNs exhibited prolonged inhibitory activity in cancer cells, as well as time-dependent increases in intracellular uptake. After intravenous administration to rats, the bioavailability of curcumin was increased by 1.25-fold. Conclusions: C-SLNs with improved dispersibility and chemical stability in an aqueous system have been successfully developed. C-SLNs may represent a potentially useful cancer therapeutic curcumin delivery system. © 2013 Elsevier B.V. Source


Shen S.,National Institute for Food and Drug Control | Shen S.,China National Institute for Nutrition and Food Safety | Yao J.,National Institute for Food and Drug Control | Shi Y.,National Institute for Food and Drug Control
Journal of Pharmaceutical and Biomedical Analysis | Year: 2014

This study assessed a general method of quantitative nuclear magnetic resonance (qNMR) for the calibration of atropine sulfate (Active Pharmaceutical Ingredient, API) as reference standard. The spectra were acquired in D2O using maleic acid as the internal standard. Conformational behaviors of tropane ring were observed and studied by means of NMR and ROESY experiments at different temperature, which showed that the azine methyl group was at equilibrium for axial and equatorial conformations at room temperature. Signal delay and monitor signals of qNMR experimentation were optimized for quantification. The study reported here validated the method's linearity, range, limit of quantification, stability and precision. The results were consistent with the results obtained from mass balance approach. © 2013 Elsevier B.V. Source


Li J.-X.,Chongqing Medical University | Li J.-X.,U.S. Center for Disease Control and Prevention | Mao Q.-Y.,National Institute for Food and Drug Control | Liang Z.-L.,National Institute for Food and Drug Control | And 2 more authors.
Expert Review of Vaccines | Year: 2014

The widespread epidemics of enterovirus 71 (EV71) seriously affected the Western Pacific Region. Young children, especially those younger than 3 years are the most susceptible population to the EV71-associated diseases. Several Asian countries have begun to focus on the research and development of EV71 vaccines. Five inactivated whole-virus EV71 candidate vaccines (three were manufactured in mainland China based on a C4 genotype strain, one in Taiwan based on a B4 genotype strain and one in Singapore based on a B2 genotype strain) have been assessed in clinical trials. Three candidate vaccines developed in mainland China have already completed Phase III clinical trials recently. The tested EV71 vaccine could provide good efficacy, satisfactory safety, and high immunogenicity. Thus, inactivated EV71 vaccines are expected to become the first available vaccines against EV71 in the near future. © 2014 Informa UK, Ltd. Source

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