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Microenvironment responsive pod-structured astaxanthin nanocarrier for ameliorating inflammatory bowel disease

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Chinese Chemical Letters 2024年第7期35卷 360-366页

作者： Jingting Wang Yuanyuan Chen Linlin Han Shasha Xia Xingyao Zhang Peng Xue Yuejun Kang Jian Ming Zhigang Xu Key Laboratory of Luminescence Analysis and Molecular Sensing Ministry of EducationSchool of Materials and Energy&Chongqing Engineering Research Center for Micro-Nano Biomedical Materials and DevicesSouthwest UniversityChongqing 400715China College of food Science Southwest UniversityChongqing 400715China State Key Laboratory of Chemo/Biosensing and Chemometrics Hunan UniversityChangsha 410082China

Anti-inflammatory drugs targeting inflammatory bowel disease(IBD)have attracted considerable attention but still face low therapeutic outcomes and frequent side ***(ATX),a natural ketone,possesses potent antioxidant and anti-inflammatory ***,it faces problems such as poor water solubility,photothermal instability,and low ***,we employed a supramolecular encapsulation strategy to create a nanoscale oral delivery system for ATX(referred to as FC-ATX NPs)by coupling fucoidan(FUC)with chitosan oligosaccharides(COS).The obtained FC-ATX NPs exhibited a particular“bean pod”structure with uniform size,good encapsulation efficiency,excellent physical and chemical stability,pH-triggered intestinal targeted slow-release properties,and potent antioxidant *** vitro cell culture experiments showed that FC-ATX NPs promoted cellular uptake and scavenged excessive intracellular reactive oxygen species(ROS).In mouse models of colitis,FC-ATX NPs enhanced the drug absorption of intestinal epithelial cells and effectively accumulated at the site of *** work provides an efficient approach to enhance the bioavailability of ATX and has excellent application potential as an oral targeted delivery system for colitis therapy.

关键词： Oral administration Astaxanthin Nanocarrier Anti-oxidant activity Colon targeting

Field-Deployable Raman Anti-Counterfeit Screening of Tamiflu Capsules

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American Journal of Analytical Chemistry 2015年第6期6卷 559-568页

作者： Yvette L. Loethen Jason D. Rodriguez US food and drug administration Center for Drug Evaluation and Research Division of Pharmaceutical Analysis St. Louis USA

In an effort to promote the availability of safe and effective drugs, the US food and drug administration is developing spectroscopic methods to assess the quality of drugs in the field. Here we report a rapid screening classification method for Tamiflu (oseltamivir phosphate) capsules using a portable Raman spectrometer to perform screening on three solid oral dosage strengths of Tamiflu, 30 mg, 45 mg and 75 mg. Tamiflu is an antiviral drug that is stockpiled for use in the event of pandemic influenza outbreak. The qualitative classification methods reported were developed using the Raman spectra of intact capsules. The classification algorithms used were able to reliably distinguish the three dosage strengths of Tamiflu. These qualitative models are validated with additional Tamiflu samples from different batches and simulated counterfeits of Tamiflu. The probability that a test sample belongs to each dosage strength class is calculated, and strict class predictions are used to assign each sample to a particular class. The classification methods reported here enable development of user-independent, field-deployable methods for finished drug products and are able to correctly assign 92% of the validation samples using authentic Tamiflu and 100% of the simulated counterfeits.

关键词： Anti-Counterfeit Portable Instruments Raman Screening

Structure-based Comparative Analysis and Prediction of N-linked Glycosylation Sites in Evolutionarily Distant Eukaryotes

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Genomics, Proteomics & Bioinformatics 2013年第2期11卷 96-104页

作者： Phuc Vinh Nguyen Lam Radoslav Goldman Konstantinos Karagiannis Tejas Narsule Vahan Simonyan Valerii Soika Raja Mazumder Life Sciences Department Paris Diderot University Department of Biochemistry and Molecular Biology George Washington University Medical Center Department of Oncology Georgetown University Center for Biologics Evaluation and Research Food and Drug Administration

The asparagine-X-serine/threonine （NXS/T） motif, where X is any amino acid except proline, is the consensus motif for N-linked glycosylation. Significant numbers of high-resolution crystal structures of glycosylated proteins allow us to carry out structural analysis of the N-linked glycosylation sites （NGS）. Our analysis shows that there is enough structural information from diverse glycoproteins to allow the development of rules which can be used to predict NGS. A Python-based tool was developed to investigate asparagines implicated in N-glycosylation in five species： Homo sapiens, Mus musculus, Drosophila melanogaster, Arabidopsis thaliana and Saccharo- myees cerevisiae. Our analysis shows that 78 % of all asparagines of NXS/T motif involved in N-gly- cosylation are localized in the loop/turn conformation in the human proteome. Similar distribution was revealed for all the other species examined. Comparative analysis of the occurrence of NXS/T motifs not known to be glycosylated and their reverse sequence （S/TXN） shows a similar distribu- tion across the secondary structural elements, indicating that the NXS/T motif in itself is not bio- logically relevant. Based on our analysis, we have defined rules to determine NGS. Using machine learning methods based on these rules we can predict with 93% accuracy if a particular site will be glycosylated. If structural information is not available the tool uses structural prediction results resulting in 74% accuracy. The tool was used to identify glycosylation sites in 108 human proteins with structures and 2247 proteins without structures that have acquired NXS/T site/s due to non-synonymous variation. The tool, Structure Feature Analysis Tool （SFAT）, is freely available to the public at http：//***/tools/sfat.

关键词： N-linked glycosylation Gain and loss of glycosyla-tion nsSNP nsSNV Variation

Characterizations in nanotoxicology and nanomedicine development:A regulatory perspective

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Characterizations in nanotoxicology and nanomedicine develop...

PCR-based methodologies for detection and characterization of Listeria monocytogenes and Listeria ivanovii in foods and environmental sources

中国毒理学会第六届全国毒理学大会

作者： ZHANG Yong-bin William SALMINEN SHI Qiang YANG Xi Yvonne JONES Paul HOWARD NCTR/ORA Nanotechnology Core Facility Food and Drug Administration Division of Systems Biology National Center for Toxicological ResearchFood and Drug Administration

＜正＞With the rapid expansion of nanotechnology,there has been great concern on safety issue of the nano-product regulated by U.S food and drug administration（FDA）.Pre-clinical characterization and quality control during the manufacturing of nano-products is fundamental for understanding resulting safety issues during their wide *** regulated products are required to submit basic physio-chemical characterization as part of Investigational New drug（IND） Applications or New drug Applications（NDA） submitted to the FDA for *** of gold nanoparticles（Au NPs）, silver nanoparticles（Ag NPs） and single walled carbon nanotubes（SWCNTs） will be discussed as cases *** nanomaterials were characterized using transmission electron microscopy（TEM）,dynamic light scattering（DLS）,Raman,and hyperspectral microscopy and other spectroscopy techniques. We examined their uptake and toxicity in primary rat hepatocytes,rat adrenal pheochromocytoma cells（PC12） or in vivo rodent *** was assessed by examining cell membrane integrity and mitochondrial activity（LDH,XTT and MTT assay） and oxidative stress（DCF assay;reduced glutathione levels;PCR array for ROS responsive gene expression）.Uptake and subcellular localization were monitored using TEM,confocal Raman microscopy and inductively coupled plasma mass spectrometry（ICP-MS） *** Au NPs were taken up by the cells in a time- and size-dependent manner,no cytotoxicity or ROS stress was ***,uptake of SWCNT was cytotoxic and generated ROS in surface coating-dependent *** SWCNT exhibited less potency than uncoated *** the other hand,Ag NPs decreased the body weight and locomotor activities after intravenous exposure in *** studies suggest the surface coating,size and composition play import roles in toxicity of the *** multiple characterization approaches used in this study provided the solid basis to understand the biological resp

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food Science and Human Wellness 2017年第2期6卷 39-59页

作者： Jin-Qiang Chen Stephanie Healey Patrick Regan Pongpan Laksanalamai Zonglin Hu Winchester Engineering&Analytical Center(WEAC) HFR-NE460Office of Regulatory AffairsUS Food and Drug Administration109 Holton StreetWinchesterMA 01890USA MD DHMH Laboratories administration Division of MicrobiologyRoom 5281770 Ashland Ave.BaltimoreMD 21205USA

Listeria monocytogenes is an important foodborne pathogen responsible for listeriosis,a fatal *** is widely distributed in various foods and environmental *** this review,we focused on addressing PCR-based technologies,including conventional PCR,qPCR and droplet digital PCR(ddPCR).Specifically,we described(a)conventional PCR and mono-,duplex-and multiplex-qPCR methodologies;(b)development and applications of gene HlyA-,Iap-,PrfA–and SsrA-based conventional and qPCR assays as well as PCR assays targeting newly identified gene targets for specific detection of ***;differentiation of viable from dead *** by qPCR in conjugation with propidium monoazide pretreatment;PCR-based serotype identification of *** isolates;PCR-based detection of ***,infecting ruminants,differentiation of *** from other Listeria species;and sigB-gene based PCR identification of Listeria spp;(c)applications of ddPCR in detection of ***;and(d)application of qPCR assays in detection and subtyping of *** in milk and dairy products;meats,meat products and meat-processing environment;and seafood,seafood products and processing *** goal was to provide a relatively comprehensive overview of PCR-based methodologies available in detection,characterization and subtyping of various strains of *** in foods and environmental sources.

关键词： foodborne pathogens Listeria monocytogenes Listeria ivanovii qPCR

Prevalence and methodologies for detection,characterization and subtyping of Listeria monocytogenes and *** in foods and environmental sources

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food Science and Human Wellness 2017年第3期6卷 97-120页

作者： Jin-Qiang Chena Patrick Regan Pongpan Laksanalamai Stephanie Healey Zonglin Hua Winchester Engineering Analytical Center(WEAC)HFR-NE460Office of Regulatory AffairsUS Food and Drug Administration109 Holton StreetWinchesterMA 01890USA MD DHMH Laboratories administration Division of MicrobiologyRoom 5281770 Ashland Ave.BaltimoreMD 21205USA

Listeria monocytogenes,one of the most important foodborne pathogens,can cause listeriosis,a lethal disease for ***,which is closely related to ***,is also widely distributed in nature and infects mainly warm-blooded ruminants,causing economic ***,there are high priority needs for methodologies for rapid,specific,cost-effective and accurate detection,characterization and subtyping of *** and *** in foods and environmental *** this review,we(A)described *** and ***,world-wide incidence of listeriosis,and prevalence of various *** strains in food and environmental sources;(B)comprehensively reviewed different types of traditional and newly developed methodologies,including culture-based,antigen/antibody-based,LOOP-mediated isothermal amplification,matrix-assisted laser desorption ionization-time of flight-mass spectrometry,DNA microarray,and genomic sequencing for detection and characterization of *** in foods and environmental sources;(C)comprehensively summarized different subtyping methodologies,including pulsed-field gel electrophoresis,multi-locus sequence typing,ribotyping,and phage-typing,and whole genomic sequencing *** subtyping of *** strains from food and environmental sources;and(D)described the applications of these methodologies in detection and subtyping of *** in foods and food processing facilities.

关键词： foodborne pathogens Listeria monocytogenes Listeria ivanovii Molecular characterization Subtyping

Simultaneous Determination of Cephaeline and Emetine in Ipecac and Its Preparations Using RP-HPLC

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Chinese Herbal Medicines 2013年第4期5卷 286-291页

作者： HAN Gui-ru WANG Yue-feng FENG Shu-hua JIA Yong-xin Hebei Provincial Institute for food and drug Control Hebei Provincial food and drug administration Bureau Hebei Ruijingkang Biological Technology Co. Ltd.

Objective To control the quality of ipecac and its preparations,and to investigate the simultaneous quantitative determination of cephaeline and *** After ultrasonic extraction with acidic methanol solution or direct diluting preparations,cephaeline hydrochloride and emetine hydrochloride in ipecac and its preparations were separated within 20 min using a mixture of acetonitrile-methanol-0.1%phosphoric acid(9:3:88)as the mobile phase on a C18column by *** detector was set at 205 *** flow rate was set at 1.0 mL/*** The methodological study showed that a good linear correlation existed in the range of 0.014 56—0.2184μg(r=0.999 97)for cephaeline hydrochloride and 0.0321—0.321μg(r=0.999 97)for emetine hydrochloride,*** average recovery of cephaeline hydrochloride and emetine hydrochloride was 96.93%and 99.47%,and the RSD values(n=9)were 1.31%and 2.02%,*** The assay is sensitive,accurate,specific,and applicable to comprehensive evaluation on the quality of ipecac and its preparations.

关键词： cephaeline hydrochloride emetine hydrochloride ipecac ipecac preparations RP-HPLC

A Rapid and Effective HPLC Method for Identification of Bovis Calculus in Chinese Patent Medicines

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Chinese Herbal Medicines 2013年第3期5卷 224-233页

作者： XIA Jing XIA Li WANG Wei-yi SHA Yi-wei WANG Ke JI Shen Shanghai Institute for food and drug Control Guangdong food and drug Vocational College Key Laboratory of Marine Biogenetic Resources Third Institute of OceanographyState Oceanic Administration (SOA) Shanghai Chongming Institute for food and drug Control

Objective Due to the limited resource and the large demand,many kinds of Bovis Calculus(BC) including artificial Bovis Calculus(ABC),in vivo cultured Bovis Calculus(in vivo CBC),and in vitro cultured Bovis Calculus(in vitro CBC)were used in Chinese patent medicines(CPMs).Previous studies have shown that the chemical constituents of ABC and their properties were different from other *** two types of CBC with much higher price than ABC were approximately equivalent with natural Bovis Calculus in quality and clinical *** aim of the study is to establish a rapid and effective method for the identification of BC in *** An HPLC method with the higher specificity for analyzing bilirubin was established to distinguish ABC from other three kinds of BC by comparing the change of bilirubin content with the addition of EDTA-2Na as the extraction solvent and *** The bilirubin content in CPMs containing ABC was basically unchanged,while that in CPMs containing other kinds of BC showed significant *** proposed method was employed to analyze a variety of CPMs containing Bovis Calculus(CPMBCs) and proven to be *** An effective analytical method is established for the quality control of CPMBCs and further ensures the safety and efficacy of these drugs in clinical practice.

关键词： artificial Bovis Calculus bilirubin Bovis Calculus Chinese patent medicines cultured Bovis Calculus EDTA-2Na solution

Development and Application of a Validated UHPLC Method for the Determination of Atropine and Its Major Impurities in Antidote Treatment Nerve Agent Auto-Injectors (ATNAA) Stored in the Strategic National Stockpiles

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Pharmacology & Pharmacy 2017年第1期8卷 15-31页

作者： Cheng H.Yen Adil Mohammad Miah Schneider Salwa K.Poole Bryan Lowry Brenda W.Mc Curdy Patrick J.Faustino Saeed R.Khan Office of Regulatory Affairs Detroit LaboratoryFood and Drug AdministrationDetroitMIUSA Division of Product Quality Research Office of Testing and ResearchOffice of Pharmaceutical QualityCenter for Drug Evaluation and ResearchFood and Drug AdministrationSilver SpringMDUSA

The development and implementation of advanced analytical technologies is essential for extending the expiry for complex drug products stored in the Strategic National Stockpiles. Consequently, a novel Ultra High-Performance Liquid Chromatographic (UHPLC) method has been developed for the analysis of atropine and its respective impurities to support the analytical research platform for auto-injectors. This study is part of a larger research effort to improve the efficiency and broaden the applicability of advanced analytical methods for medical counter-measure medications. The current HPLC compendial methodology for atropine sulfate injection requires an analysis time of 40 minutes for atropine. In comparison, the novel gradient UHPLC method required only 8 minutes to evaluate both atropine and its major pharmaceutical impurities. Improved separation was achieved on a Waters Acquity UHPLC BEH C18 1.7 μm, 2.1 × 100 mm column employing gradient elution of mobile phase solvent A (0.1% H3PO4) and solvent B (0.1% H3PO4, 90% ACN, and 10% H2O). The method was validated according to USP Category I requirements for assay. The daily standard calibration curves were linear over a concentration range from 50 μg/mL to 250 μg/mL with a correlation coefficient of >0.999. The detection limit (LOD) and quantitation limit (LOQ) were 3.9 μg/ml and 13.1 μg/ml, respectively. Resolution results indicate that atropine and the following impurities, degradants and a preservative can also be separated and analyzed using this proposed method: noratropine, 4,4’-di-hy-droxydiphenyl ether, 2,4’-dihydroxydiphenyl ether, 4-bromophenol, 4-hydro-xyatropine, tropic acid, apoatropine HCl, atropic acid, hydroquinone, nitroethane, phenol and catechol. The UHPLC method demonstrated enhanced selectivity and significantly reduced the analysis time when compared with the traditional USP compendial HPLC method. The method was successfully applied to the evaluation of atropine in ATNAA auto-injectors lots fro

关键词： Atropine Sulfate Atropine ATNAA SLEP UHPLC Impurities