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Synthesis, Crystal Structure, Thermal Stability and Solid UV-Vis Absorption Spectra of One New Copper(Ⅱ) Coordination Polymer

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Chinese Journal of Structural Chemistry 2019年第9期38卷 1537-1542页

作者： XUE Li-Ping College of food and drug Luoyang Normal University

A new coordination polymer [Cu2(OH)(nbta)(tib)(H2 O)2]n(1, H3 nbta = 5-nitro-1,2,3-benzenetricarboxylic acid, tib = 1-(4 H-1,2,4-triazol-4-yl)-4-(imidazol-1-yl)benzene) constructed from dimeric Cu(Ⅱ) units has been synthesized under hydrothermal conditions and structurally characterized by single-crystal X-ray diffraction analysis. The compound crystallizes in monoclinic system, space group I2/c, with a = 17.8474(9), b = 11.7588(6), c = 21.9221(11) ?, β = 104.419(5)°, V = 4455.7(4) ?3 and Z = 8. Compound 1 is a three-dimensional structure constructed from dimeric Cu(Ⅱ) units and presents a 2-nodal(3,5)-connected net. Moreover, the thermal stability and solid UV-Vis absorption spectra have been investigated.

关键词： copper coordination polymer crystal structure topology UV–Vis absorption spectra

Synthesis and evaluation of monoclonal antibody against Plasmodium falciparum merozoite surface antigen 2

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Asian Pacific Journal of Tropical Medicine 2013年第10期6卷 798-803页

作者： Afra Khosravi Eghbaleh Asadollahy Sobhan Ghafourian Nourkhoda Sadeghifard Reza Mohebi Immunology Department Faculty of MedicineIlam University of Medical Sciences food and drug Department Food and Drug DeputyIlam University of Medical Sciences Clinical Microbiology research centre Ilam University of Medical Sciences

Objective:To assess the quality of expressed MSP-2 and also to confirm the immune response against different domains of these ***:Mice were immunized with a schizont extract to stimulate the immune system to make antibodies against different antigens of the late stage parasite including production of antibodies against different domains of Plasmodium falciparum(***)MSP-2.B lymphocytes of immunized mice were extracted from the spleen and the fusion was performed using NS-1 myeloma cells and the hybridoma cells were assayed by ELISA either with a schizont extract or different domains of MSP-2 and/or by IFAT with whole schizont *** of NS-1 and spleen cells was *** positive hybrids were cloned and ELISA was applied against different *** positive clones were transferred to a small tissue culture flask and after developing they were assayed against schizont extract and the different MSP-2 *** positive clones were expanded to large(75 cm^2)flask and cultured under the same conditions,checking them using both ELISA and IFAT and the positive cells were frozen as soon as ***:A total number of 7 fusions including 26 plates(2496 wells)were performed,of which 1336 hybrids were produced and the overall efficiency(1336/24%×100)was about 53%.ELISA was performed to detect the positive hybrids against crude schizont extract by which the highest frequency to crude schizont extract was found for the supernatant of the hybrids produced in fusion number 3(66 out of 315 hybrids).The supernatant of both B5 and Ft hybridoma cells were more positive against domain 2 of the MSP-2 recombinant protein in Western blotting *** blotting results also showed that different domains of the MSP-2 recombinant protein and also the MSP-2 of the *** parasite were recognized by some of the positive clones and also immune ***:Bringing together all the results of this study it has been confirmed that s

关键词： MSP-2 Monoclonal antibody Malaria Diagnosis

Quantification of flupirtine maleate polymorphs using X-ray powder diffraction

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Chinese Chemical Letters 2016年第11期27卷 1666-1672页

作者： Yu-Mei Zhao Zhi-Bing Zheng Song Li Laboratory of Computer-Aided drug Design & Discovery Beijing Institute of Pharmacology and Toxicology Laboratory of Structure Identification Beijing Institute of Pharmacology and Toxicology State Key Laboratory of toxicology and Medical Countermeasures Beijing Institute of Pharmacology and Toxicology

Flupirtine maleate, a pharmaceutical compound for treating psychotic disease in clinics, has seven polymorphs. Form A, with better crystal stability and bioavailability, has been widely used as the pharmaceutical crystal form. Unfortunately, it is usually found in a polymorphic mixture with form B. In this study, pure crystal forms of A and B were prepared and characterized by X-ray powder diffraction （XRPD）, Fourier transform infrared spectroscopy （FT-IR） and thermal analysis. An XRPD-based method for the quantitative determination of the amount of the flupirtine maleate polymorphs form A and form B was also established through a systematic optimization of instrumental parameters. The results of the analytical methodology validation showed that the XPRD method had a broad quantitative range of 0- 100% （w/w）, good linear relationship, with R2= 0.999, excellent repeatability and precision and low limits of detection （LoD） of 0.15% （w/w） and quantification （LoQ） of 0.5% （w/w）. The results also showed that the single-peak method was not as good as the whole pattern in reducing the influence of the preferred orientation, but this can be compensated for by a systematic optimization of instrumental parameters and validating the analytical methodology to reduce errors and obtain a good, repeatable, sensitive, and accurate method. This XRPD method can be used to analyze mixtures of flupirtine maleate polymorphs （forms A and B） quantitatively and control the quality of the bulk drug.

关键词： Flupirtine maleate X-ray powder diffraction Quantitative analysis of polymorphs Preferred orientation Transmission

Guidelines and strategy of the International Conference of Harmonization(ICH) and its member states to overcome existing impurity control problems for antibiotics in China

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Chinese Journal of Natural Medicines 2015年第7期13卷 498-506页

作者： JIANG Yu XIA Jun-Ping YANG Jian-Hong ZHANG Zhe-Feng HU Chang-Qin ZHANG Zhi-Rong Key Laboratory of drug Targeting and drug Delivery System Ministry of EducationWest China School of PharmacySichuan University Center for drug Evaluation China Food and Drug Administration China Pharmaceutical University China National Institutes for food and drug Control

In the present report,we review the technical guidelines and principles on impurity research and control for antibiotics established by various agencies,including the International Conference of Harmonization(ICH),the US food and drug Administration(FDA),the European Medicines Agency(EMA) and the China food and drug Administration(CFDA).Progresses with the US Pharmacopoeia(USP),the European Pharmacopoeia(EP) and the Chinese Pharmacopoeia(ChP) to control impurities in antibiotics are also ***,our discussion is focused on analyzing the CFDA's requirements on impurity research and control for antibiotics,and the implementation of ICH,FDA and other technical guidelines for generic drugs impurity control in *** problems are further reviewed,in order to improve the overall process for the control of antibiotic

关键词： China Impurity control Antibiotics Bridging Guidelines

Early-phase clinical trials of anti-HIV drugs——understanding and discussion

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Science China(Life Sciences) 2009年第6期52卷 521-527页

作者： LI YaJie,ZHAO Ming & ZHAO DeHeng Center for drug Evaluation,State food and drug Administration,Beijing 100038,China Center for drug Evaluation State Food and Drug Administration Beijing China

Innovative anti-HIV drugs developed by local sponsors in China have come into the stage of early-phase clinical *** to systemically design the clinical trials of innovative anti-HIV drugs still remains a challenge for *** article references the literature and the experience of reviewers,to introduce general considerations concerning early-phase clinical trials of innovative anti-HIV drugs.

关键词： HIV tolerance dose exploration drug-drug interaction drug resistance

Comprehensive characterization and detection of nut allergens in bakery foods using Q-TOF mass spectrometry and bioinformatics

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food Quality and Safety 2024年第1期8卷 145-157页

作者： Daokun Xu Haolun Huang Zhen Liu YumeiWang Qinan Liu Xing Jiang JunYang Rui Ling Nanjing Institute for food and drug Control NanjingChina State Key Laboratory of food Science and Technology School of Food Science and TechnologyJiangnan UniversityWuxiChina Demonstration Collaborative Laboratory of Analysis and Detection Technology for food and drug Safety Nanjing Institute for Food and Drug Control and Agilent Technologies(China)NanjingChina Collaborative Laboratory for food Safety Nanjing Institute for Food and Drug Control and SCIEX(China)NanjingChina

food allergy is a growing health issue worldwide and the demand for sensitive,robust and high-throughput analytical methods is *** recent years,mass spectrometry-based methods have been established for multiple food allergen *** the present study,a novel method was developed for the simultaneous detection of almond,cashew,peanut,and walnut allergens in bakery foods using liquid chromatography–mass *** unique to these four ingredients were extracted,followed by trypsin digestion,quadrupole time-of-flight(Q-TOF)mass spectrometry and bioinformatics *** raw data were processed by de-novo sequencing module plus PEAKS DB(database search)module of the PEAKS software to screen peptides specific to each nut *** thermal stability and uniqueness of these candidate peptides were further verified using triple quadrupole mass spectrometry(QQQ-MS)in multiple reaction monitoring(MRM)*** nut species was represented by four peptides,all of which were validated for label-free quantification(LFQ).Calibration curves were constructed with good linearity and correlation coefficient(r 2)greater than *** limits of detection(LODs)were determined to range from 0.11 to 0.31 mg/kg,and were compared with the reference doses proposed by Voluntary Incidental Trace Allergen Labelling(VITAL).The recoveries of the developed method in incurred bakery food matrices ranged from 72.5%to 92.1%with relative standard deviations(RSD)offood samples confirmed the presence of these *** conclusion,this method provides insight into the qualitative and quantitative detection of trace levels of nut allergens in bakery foods.

关键词： Nut allergen Q-TOF mass spectrometry peptides label-free quantitation bakery foods.

New era of drug innovation in China

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Acta Pharmaceutica Sinica B 2019年第5期9卷 1084-1085页

作者： Xuan Ye Qingli Wang Haixue Wang Office of Pharmacology and toxicology Center for drug Evaluation National Medical Products Administration

In 2018, the China National Medical Products Administration(NMPA) approved new drug applications (NDAs) of 48 new drugs, which was the highest annual approval rate by the Chinese regulatory agency in the past 20 years. Nine of the 48 new drugs,including fruquintinib, anlotinib, toripalimab and sintilimab, are global new molecular entities (NME) that were developed by Chinese pharmaceutical companies.

关键词： New era drug innovation China

Teratogenicity Studies of a New Potent Tetanus Vaccine in Rabbit (Oryctolagus cuniculus)

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Biomedical and Environmental Sciences 1991年第3期4卷 327-331页

作者： N.SETHI R.K.SRIVASTAVA R.K.SINGH Division of toxicology Central Drug Research Institute Lucknow 226001 IndiaDivision of Toxicology Central Drug Research Institute Lucknow 226001 IndiaDivision of Toxicology Central Drug Research Institute Lucknow 226001 India

Glaxo Laboratories, Bombay, have prepared a potent tetanus vaccine of 250 Lf as a substitute of the previous 5 Lf tetanus vaccine. The safety evaluation of the vaccine has been reported, but the teratogenic potential was not studied. In the experiment reported herein we have studied the teratogenic action of the vaccine in the progeny of rabbits. No congenital anomalies were observed.

关键词： In Oryctolagus cuniculus Teratogenicity Studies of a New Potent Tetanus Vaccine in Rabbit

COVID-19 vaccines: progress and understanding on quality control and evaluation

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Signal Transduction and Targeted Therapy 2021年第6期6卷 1646-1652页

作者： Qunying Mao Miao Xu Qian He Changgui Li Shufang Meng Yiping Wang Bopei Cui Zhenglun Liang Junzhi Wang National Institutes for food and drug Control BeijingChina

The outbreak of COVID-19 has posed a huge threat to global health and *** have revolutionized norms for working,socializing,learning,and ***,vaccines have been considered as most effective tools to combat with *** of the beginning of 2021,>200 COVID-19 vaccine candidates,covering nearly all existing technologies and platforms,are being research and development(R&D)by multiple manufacturers *** has posed a huge obstacle to the quality control and evaluation of those candidate vaccines,especially in China,where five vaccine platforms are deployed in *** accelerate the R&D progress of COVID-19 vaccines,the guidances on R&D of COVID-19 vaccine have been issued by National Regulatory Authorities or organizations *** Center for drug Evaluation and national quality control laboratory in China have played a leading role in launching the research on quality control and evaluation in collaboration with relevant laboratories involved in the vaccine R&D,which greatly supported the progression of vaccines R&D,and accelerated the approval for emergency use and conditional marketing of currently vaccine *** this paper,the progress and experience gained in quality control and evaluation of COVID-19 vaccines developed in China are summarized,which might provide references for the R&D of current and next generation of COVID-19 vaccines worldwide.

关键词： approval gained travel