172 results match your criteria: "Shanghai Institute for Food and Drug Control[Affiliation]"

Rapid and Sensitive Detection of via Immunomagnetic Separation and Nanoparticle-Enhanced SPR.

Microorganisms

August 2025

School of Agriculture and Biology, Bor S. Luh Food Safety Research Center, Shanghai Jiao Tong University, Shanghai 200240, China.

The widespread prevalence of underscores the urgent need for rapid, sensitive, and reliable detection methods to ensure food safety and protection of public health. In this study, we successfully developed an integrated detection system that combines immunomagnetic separation with surface plasmon resonance (SPR) analysis. This system achieved high capture efficiencies, exceeding 96.

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[Quantification of viral particles in adenovirus vector-based vaccines by nano-flow cytometry].

Sheng Wu Gong Cheng Xue Bao

August 2025

NMPA Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies, Shanghai Institute for Food and Drug Control, Shanghai 201203, China.

This study aims to establish a method for counting the viral particles in adenovirus vector-based vaccines. Nano-flow cytometry was employed to analyze the viral particles in adenovirus-based vector vaccines at the single-particle level. Monodisperse silica nanoparticles with a refractive index close to that of the virus were selected as the particle size standard to calculate the viral particle size, which was then compared with the results obtained from transmission electron microscopy (TEM) to determine the gating strategy.

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To develop a method for determining the antibody-dependent cell-mediated phagocytosis (ADCP) activity of human epidermal growth factor receptor 2 (HER2)-targeted antibody drug conjugate (ADC) based on the reporter gene assay, we established an ADCP activity assay with Jurkat/NFAT/FcγRIIa cells as the effector cells and BT474 as the target cells. Then, the target cell density, the ratio of effector to target cells, the target cell adhesion time, the incubation time for drug administration, and the induction time after adding effector cells were optimized by the method of design of experiment (DOE). The method showed a significant dose-response relationship, which was complied with the four-parameter equation: =(A-D)/[1+(/C)]+D.

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Microbial contamination threatens food safety, and traditional microbial risk assessment methods struggle with complex supply chains and microbial diversity. This paper reviews emerging detection technologies' applications in food safety, highlighting their role in advancing risk assessment and future research directions.

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Identification and quantification of a novel PDE-5 inhibitor, Dasantafil, found as an adulterant in a pressed candy dietary supplement.

J Pharm Biomed Anal

November 2025

School of Pharmacy, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China; NMPA Key Laboratory for Quality Control of Traditional Chinese Medicine, Shanghai Institute for Food and Drug Control, Shanghai 201203, China. Electronic address:

During non-targeted screening of a pressed candy dietary supplement, an unidentified compound was detected and subsequently isolated through prep-HPLC. Comprehensive structural elucidation employing high-performance liquid chromatography-diode array detection (HPLC-DAD), ultra-high-performance liquid chromatography-quadrupole time-of-flight tandem mass spectrometry (UHPLC/Q-TOF MS), and one-dimensional (1D) and two-dimensional (2D) nuclear magnetic resonance (NMR) spectroscopy confirmed the compound as Dasantafil (CHNOBr), a phosphodiesterase-5 (PDE-5) inhibitor. HPLC quantification revealed a content of 9.

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fruit is a food-as-medicine species extensively used in diverse phytotherapeutical applications. Spurred by its widespread use, this study employed a modified MTBE-based lipid extraction procedure on raw and vinegar-processed fruit. Subsequently, lipid composition analysis was conducted using ultra-high-performance liquid chromatography interfaced with ion mobility-quadrupole time-of-flight mass spectrometry.

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DNA-programmed responsive microorganism assembly with controlled patterns and behaviors.

Sci Adv

June 2025

Institute of Chemical Biology and Nanomedicine, State Key Laboratory of Chemo and Biosensing, Hunan Provincial Key Laboratory of Bio-macromolecular Chemical Biology, College of Chemistry and Chemical Engineering, Hunan University, Changsha 410082, China.

Programming microorganism adhesions to engineer multicellular microbial communities holds promise for synthetic biology and medicine. Current chemical and genetic engineering approaches often lack specificity or require engineered bacteria, making the design of responsive interactions challenging. Here, we demonstrate the use of functional DNA as programmable surface receptors to regulate the patterns and behaviors of microbial communities.

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The safety evaluation of herbal medicines faces a critical challenge due to exogenous pesticide residues, where traditional detection methods struggle to address the dual complexity of highly variable phytochemical matrices and trace-level multi-residue contaminants. Recent regulatory shifts emphasizing large-scale detection have positioned liquid chromatography coupled with high-resolution mass spectrometry (LC-HRMS) as a transformative solution. This review systematically examines cutting-edge LC-HRMS workflows tailored for complex herbal matrices, with three pivotal technical dimensions: (1) Matrix-specific optimization spanning from QuEChERS-based sample preparation to chromatographic separation protocols that reduce matrix interferences; (2) Intelligent data acquisition strategies balancing selectivity and coverage through adaptive MS/MS triggering and narrow-window fragmentation; (3) Integrated analytical frameworks combining targeted screening with expanding pesticide databases and non-targeted approaches leveraging retrospective HRMS data mining.

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Protamine is a natural cationic peptide which has been utilized as a food preservative, since its antibacterial capability against a wide range of Gram-negative and -positive bacteria. Despite the antibacterial mechanism has been well uncovered, its role in complex food microbial communities is largely elusive. In the present study, grass carp (Ctenopharyngodon idellus) fillets were treated with protamine and a protamine-based compound preservative, and stored at 4 °C for 15 days.

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A High-Throughput Screening Strategy for Producing Menaquinone-7 Based on Fluorescence-Activated Cell Sorting.

Microorganisms

February 2025

School of Agriculture and Biology, Bor S. Luh Food Safety Research Center, Shanghai Jiao Tong University, Shanghai 200240, China.

Menaquinone-7 (MK-7) is recognized for its important biological activity, and is the preferred strain for its fermentative production. However, the limited phenotypic diversity among high-yielding strains complicates the development of rapid screening methods. To address this, we utilized the effect of MK-7 on transmembrane potential to develop a high-throughput screening (HTS) strategy for efficiently identifying strains with improved MK-7 production.

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Establishment of a subvisible particle profile in ophthalmic recombinant fusion protein and antibody formulations to control and monitor drug quality.

Int J Pharm

April 2025

State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, National Institutes for Food and Drug Control, Beijing, China. Electronic address: wangl

The presence of subvisible particles in intravitreal injection ophthalmic formulations may affect drug efficacy and safety. Although Chapters 788 and 789 of the United States Pharmacopeia limit the concentration of particles ≥ 10 μm, particles less than 10 μm may cause blurred vision and floaters in the injected eyes. Due to limited access to ophthalmic protein formulations, few studies investigated the profile of subvisible particles in these formulations.

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In the process of a routine illegal adulterant inspection of food products sold online, a suspicious compound was detected in a dried plum food product, which claimed to have a natural weight loss effect. After mass spectrometric analysis the similarity between MS/MS peaks of this compound and that of bisacodyl, it was hypothesized to be a bisacodyl derivative. The chemical structure of the unknown compound was characterized by ultra-HPLC with quadrupole time-of-flight tandem mass spectrometry (UHPLC/Q-TOF MS), HPLC-diode array detection (HPLC-DAD) and nuclear magnetic resonance (NMR) methods.

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Decoding Protein Glycosylation by an Integrative Mass Spectrometry-Based Sequencing Strategy.

JACS Au

February 2025

Analytical Research Center for Organic and Biological Molecules, State Key Laboratory of Drug Research, Carbohydrate-Based Drug Research Center, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, 555 Zuchongzhi Road, Shanghai 201203, China.

Glycoproteins, representing more than 50% of human proteins and most biopharmaceuticals, are crucial for regulating various biological processes. The complexity of multiple glycosylation sites often leads to incomplete sequence coverage and ambiguous glycan modification profiles. Here, we developed an integrative mass spectrometry-based approach for decoding unknown glycoproteins, which is featured with the combination of deglycosylation-mediated sequencing with glycosylation site characterization.

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The current status of multi-mycotoxin contamination in edible and medicinal plants demands urgent development of high-throughput analytical methods for mycotoxin detection. In this study, a reliable and sensitive method for the simultaneous analysis of 73 mycotoxins was established and successfully applied to detect mycotoxins in 260 samples of four dual-purpose plants (lotus seed, coix seed, licorice root, and dried tangerine peel). Sample preparation involved optimized QuEChERS (Quick, Easy, Cheap, Effective, Rugged, and Safe) extraction combined with liquid-liquid extraction purification, and an enhanced ion pair library was established to reduce matrix interference and improve the method's universality.

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Red yeast rice is a nutraceutical fermented product used worldwide for the symptomatic relief of dyslipidemia and cardiovascular disease. However, the fermentation-induced lipid transformation from rice to red yeast rice remains unclear. Herein, an ultra-high performance liquid chromatography coupled with hybrid quadrupole-orbitrap mass spectrometry method was developed for the comprehensive lipid analysis during fermentation.

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Determination of Puberulic Acid in Monascus-Fermented Red Yeast Rice by LC-MS/MS Combined with Precolumn Derivatization.

Toxins (Basel)

December 2024

NMPA Key Laboratory for Quality Control of Traditional Chinese Medicine, Shanghai Institute for Food and Drug Control, 1500 Zhangheng Road, Shanghai 201203, China.

Puberulic acid (PA) is a mycotoxin produced by a species of . It has received widespread attention as a significant contributor to the reported fatalities associated with red yeast rice dietary supplements. However, the detection of PA, especially at low concentration levels, poses a considerable challenge, with no detection methods reported thus far.

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Reducing the time required for the detection of bacteria in blood samples is a critical area of investigation in the field of clinical diagnosis. Positive blood culture samples often require a plate culture stage due to the interference of blood cells and proteins, which can result in significant delays before the isolation of single colonies suitable for matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) analysis. In this study, we developed a non-specific enrichment strategy based on SiO-encapsulated FeO nanoparticles combined with MALDI-TOF MS for direct identification of bacteria from aqueous environments or positive blood culture samples.

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Article Synopsis
  • Developed a colloidal gold immunochromatographic strip (CGIS) method for accurately measuring total aflatoxins in herbal medicines, addressing flaws in traditional methods.
  • The CGIS method showed high accuracy with a detection range of 2.5 to 40 μg/kg and a limit of detection (LOD) at 1 μg/kg, yielding recovery rates between 65.1% and 98.6%.
  • The study found that CGIS results aligned well with those from HPLC-FLD, allowing for significant time savings in testing and reducing retesting workload by over 90%.
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Effects of typical plant growth regulator chlormequat chloride on alkaloidal compounds in Corydalis yanhusuo and molecular mechanisms.

Ecotoxicol Environ Saf

January 2025

Tongren Hospital, Shanghai Jiao Tong University School of Medicine, 1111 Xianxia Road, Changning District, Shanghai 200336, China; Hongqiao International Institute of Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, 720 Xianxia Road, Changning District, Shanghai 200336

The effects of chlormequat chloride, a typical plant growth regulator, on the medicinal herb Corydalis yanhusuo were investigated. A standardized field experiment was conducted to investigate the molecular mechanisms and variations in active compounds resulting from chlormequat chloride treatment. Samples of C.

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Niche-specific evolution and gene exchange of Salmonella in retail pork and chicken.

Food Res Int

December 2024

College of Food Science and Engineering, Northwest A&F University, Yangling 712100, China. Electronic address:

Salmonella exhibits extensive genetic diversity, facilitated by horizontal gene transfer occurring within and between species, playing a pivotal role in this diversification. Nevertheless, most studies focus on clinical and farm animal isolates, and research on the pangenome dynamics of Salmonella isolates from retail stage of the animal food supply chain is limited. Here, we investigated the genomes of 950 Salmonella isolates recovered from retail chicken and pork meats in seven provinces and one municipality of China in 2018.

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A sensitive and simple method using ultra-liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) was developed and validated to determine the concentration of curcumin in rat plasma and tissue samples. Emodin was selected as the internal standard (IS), and biological samples were pretreated with simple one-step acetonitrile precipitation. The calibration curves exhibited linearity within the range of 1-1000 ng/ml for both rat plasma and tissue samples.

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Article Synopsis
  • Existing Skin-on-a-Chip (SoC) technology faces limitations due to complex structures and the need for multiple devices, hindering the assessment of harmful chemicals that impact liver health after skin contact.
  • A new gravity-driven SoC was developed, featuring three layers of cell chambers (human skin, blood vessel cells, and liver cells) that allows for effective study of liver toxicity from exogenous chemicals, with validation through specific parameters.
  • This SoC accurately mimics the way chemicals are absorbed through the skin, processed in the bloodstream, and affect the liver, offering a potential substitute for animal testing in evaluating the safety of skin-penetrating chemicals.
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Microstructure and digestive behaviors of inner, middle, and outer layers of pork during heating.

Food Chem

November 2024

National Key Laboratory of Meat Quality Control and Cultured Meat Development, MOST, Key Laboratory of Meat Processing and Quality Control, MOE, Key Laboratory of Meat Processing, MARA, Jiangsu Collaborative Innovation Center of Meat Production, Processing and Quality Control, College of Food Scienc

To investigate the effects of heat treatment on the microstructure and digestive behaviors of pork, meat samples were subjected to a 100 °C water bath for 26 min. The inner, medium, and outer layers were assigned and analyzed according to the temperature gradient. Compared to the raw samples, significant changes were observed in the microscopic structure of pork.

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Discovery of baicalein derivatives as novel inhibitors against human pancreatic lipase: Structure-activity relationships and inhibitory mechanisms.

Int J Biol Macromol

August 2024

Shanghai Frontiers Science Center of TCM Chemical Biology, Institute of Interdisciplinary Integrative Medicine Research, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China. Electronic address:

Human pancreatic lipase (hPL) is a vital digestive enzyme responsible for breaking down dietary fats in humans, inhibiting hPL is a feasible strategy for preventing and treating obesity. This study aims to investigate the structure-activity relationships (SARs) of flavonoids as hPL inhibitors, and to find potent hPL inhibitors from natural and synthetic flavonoids. In this work, the anti-hPL effects of forty-nine structurally diverse naturally occurring flavonoids were assessed and the SARs were summarized.

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The Professional Committee of Microbiology of the National Pharmacopoeia Commission organized the drafting of the Technical Guidelines for Microbial Whole Genome Sequencing (WGS), aiming to standardize the method process and technical indicators of microbial WGS and ensure the accuracy of sequencing and identification. On the basis of the Guidelines, we developed an integrated microbial identification and source tracking (MIST) system, which could meet the needs of microbial identification and contamination investigation in food and drug quality control. MIST integrates three analysis pipelines: 16S/18S/internal transcribed spacer amplicon-based microbial identification, WGS-based microbial identification, and single-nucleotide polymorphism-based microbial source tracking.

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