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Neonatal Exposure to Propofol Interferes with the Proliferation and Differentiation of Hippocampal Neural Stem Cells and the Neurocognitive Function of Rats in Adulthood via the Akt/p27 Signaling Pathway

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Biomedical and Environmental Sciences 2022年第4期35卷 283-295页

作者： MIAO Hui Hui LIU Wen Bo JIAO Xin Hao SHAO Ke Jie YUAN Ying Xuan SHA Sha ZHANG Qi Qi YAN Jing SUN Yin Ying ZHOU Cheng Hua WU Yu Qing Department of Anesthesiology Beijing Shijitan HospitalCapital Medical UniversityBeijing 100038China Jiangsu Province key laboratory of Anesthesiology Xuzhou Medical UniversityXuzhou 221004JiangsuChina Jiangsu key laboratory of New drug research and Clinical Pharmacy Xuzhou Medical UniversityXuzhou 221004JiangsuChina nmpa key laboratory for research and evaluation of Narcotic and Psychotropic drugs Xuzhou Medical UniversityXuzhou 221004JiangsuChina

Objective Neonatal exposure to propofol has been reported to cause neurotoxicity and neurocognitive decline in adulthood;however,the underlying mechanism has not been established.Methods SD rats were exposed to propofol on postnatal day 7(PND-7).Double-immunofluorescence staining was used to assess neurogenesis in the hippocampal dentate gyrus(DG).The expression of pAkt and p27 were measured by western blotting.The Morris water maze,novel object recognition test,and object location test were used to evaluate neurocognitive function 2-month-old rats.Results Phosphorylation of Akt was inhibited,while p27 expression was enhanced after neonatal exposure to propofol.Propofol also inhibited proliferation of neural stem cells(NSCs)and decreased differentiation to neurons and astroglia.Moreover,the neurocognitive function in 2-month-old rats was weakened.Of significance,intra-hippocampal injection of the Akt activator,SC79,attenuated the inhibition of p-AKT and increase of p27 expression.SC79 also rescued the propofol-induced inhibition of NSC proliferation and differentiation.The propofol-induced neurocognition deficit was also partially reversed by SC79.Conclusion Taken together,these results suggest that neurogenesis is hindered by neonatal propofol exposure.Specifically,neonatal propofol exposure was shown to suppress the proliferation and differentiation of NSCs by inhibiting Akt/p27 signaling pathway.

关键词： Propofol Neurogenesis Hippocampal dentate gyrus Akt p27

Standardized neutralization antibody analytical procedure for clinical samples based on the AQbD concept

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Signal Transduction and Targeted Therapy 2023年第5期8卷 2078-2080页

作者： Jianyang Liu Yu Bai Mingchen Liu Dejiang Tan Jing Li Zhongfang Wang Zhenglun Liang Miao Xu Junzhi Wang Qunying Mao National Institutes for Food and drug Control BeijingChina NHC key laboratory of research on Quality and Standardization of Biotech Products BeijingChina nmpa key laboratory for Quality research and evaluation of Biological Products BeijingChina Sinovac Life Science Co. Ltd.BeijingChina Guangzhou laboratory GuangzhouGuangdong ProvinceChina

Dear Editor,Vaccination is an effective strategy for controlling the COVID-19 pandemic and reducing the number of cases of hospitalization and deaths.1 Neutralizing antibody(Ntab)is one of the key indicators for evaluating the effectiveness of COVID-19 vaccines.2 Over 40 COVID-19 vaccines have been approved for emergency use,marketing,or marketing with conditions,and the available Ntab data from clinical trials have been published.

关键词： clinical QbD cases

Regulatory perspectives of combination products

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Bioactive Materials 2022年第4期7卷 492-503页

作者： Jiaxin Tian Xu Song Yongqing Wang Maobo Cheng Shuang Lu Wei Xu Guobiao Gao Lei Sun Zhonglan Tang Minghui Wang Xingdong Zhang Center for Medical Device evaluation National Medical Products AdministrationBeijingChina nmpa key laboratory for Quality research and Control of Tissue Regenerative Biomaterial&Institute of Regulatory Science for Medical Devices&nmpa research Base of Regulatory Science for Medical Devices Sichuan UniversityChengduChina National Engineering research Center for Biomaterials&College of Biomedical Engineering Sichuan UniversityChengduChina Center for drug evaluation National Medical Products AdministrationBeijingChina

Combination products with a wide range of clinical applications represent a unique class of medical products that are composed of more than a singular medical device or drug/biological product.The product research and development,clinical translation as well as regulatory evaluation of combination products are complex and challenging.This review firstly introduced the origin,definition and designation of combination products.key areas of systematic regulatory review on the safety and efficacy of device-led/supervised combination products were then presented.Preclinical and clinical evaluation of combination products was discussed.Lastly,the research prospect of regulatory science for combination products was described.New tools of computational modeling and simulation,novel technologies such as artificial intelligence,needs of developing new standards,evidence-based research methods,new approaches including the designation of innovative or breakthrough medical products have been developed and could be used to assess the safety,efficacy,quality and performance of combination products.Taken together,the fast development of combination products with great potentials in healthcare provides new opportunities for the advancement of regulatory review as well as regulatory science.

关键词： Combination products Definition Designation Safety and efficacy Regulatory science

Micro/nanomotor: A promising drug delivery system for cancer therapy

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ChemPhysMater 2023年第2期2卷 114-125页

作者： Weihan Zhang Zipeng Zhang Shunli Fu Qingping Ma Yongjun Liu Na Zhang Department of Pharmaceutics Key Laboratory of Chemical Biology(Ministry of Education)NMPA Key Laboratory for Technology Research and Evaluation of Drug ProductsSchool of Pharmaceutical SciencesCheeloo College of MedicineShandong UniversityJinan 250012China

Micro/nanomotors(MNMs)are small-scale devices that can effectively convert various forms of energy into mechanical motion.Their controllable motility and good permeability have attracted the interest of researchers as promising drug carriers in cancer therapy.Compared with traditional formulations,micro/nanomotor drug delivery systems can greatly improve therapeutic efficiency and reduce the side effects of antitumor drugs.This review mainly discusses the advantages of micro/nanomotor drug delivery systems and the applications of MNMs propelled by exogenous,endogenous,and biohybrid power in cancer therapy.Finally,the main challenges of the applications of micro/nanomotor drug delivery systems,as well as future development trends and opportunities are discussed.

关键词： Micro/nanomotor Cancer therapy drug delivery systems Controllable movement

Immunogenicity and protective efficacy of a recombinant protein subunit vaccine and an inactivated vaccine against SARS-CoV-2 variants in non-human primates

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Signal Transduction and Targeted Therapy 2022年第4期7卷 1170-1180页

作者： Qian He Qunying Mao Xiaozhong Peng Zhanlong He Shuaiyao Lu Jialu Zhang Fan Gao Lianlian Bian Chaoqiang An Wenhai Yu Fengmei Yang Yanan Zhou Yun Yang Yanyan Li Yadi Yuan Xujia Yan Jinghuan Yang Xing Wu Weijin Huang Changgui Li Junzhi Wang Zhenglun Liang Miao Xu Division of Hepatitis and Enterovirus Vaccines Institute of Biological ProductsNational Institutes for Food and Drug ControlNHC Key Laboratory of Research on Quality and Standardization of Biotech ProductsNMPA Key Laboratory for Quality Research and Evaluation of Biological ProductsBeijing 102629People’s Republic of China Institute of Medical Biology Chinese Academy of Medicine Sciences&Peking Union Medical CollegeKunming 650118People’s Republic of China

Emerging SARS-CoV-2 variants and the gradually decreasing neutralizing antibodies over time post vaccination have led to an increase in incidents of breakthrough infection across the world.To investigate the potential protective effect of the recombinant protein subunit COVID-19 vaccine targeting receptor-binding domain(RBD)(PS-RBD)and whole inactivated virus particle vaccine(IV)against the variant strains,in this study,rhesus macaques were immunized with PS-RBD or IV vaccine,followed by a Beta variant(B.1.351)challenge.Although neutralizing activity against the Beta variant was reduced compared with that against the prototype,the decreased viral load in both upper and lower respiratory tracts,milder pathological changes,and downregulated inflammatory cytokine levels in lung tissues after challenge demonstrated that PS-RBD and IV still provided effective protection against the Beta variant in the macaque model.Furthermore,PS-RBD-induced macaque sera possessed general binding and neutralizing activity to Alpha,Beta,Delta,and Omicron variants in our study,though the neutralizing antibody(NAb)titers declined by varying degrees,demonstrating potential protection of PS-RBD against current circulating variants of concern(VOCs).Interestingly,although the IV vaccine-induced extremely low neutralizing antibody titers against the Beta variant,it still showed reduction for viral load and significantly alleviated pathological change.Other correlates of vaccine-induced protection(CoP)like antibody-dependent cellular cytotoxicity(ADCC)and immune memory were both confirmed to be existing in IV vaccinated group and possibly be involved in the protective mechanism.

关键词： protective vaccine neutral

Diastereodivergent[4+2]annulation of biphenylenes with enones via nickel(0)-catalyzed C-C bond activation

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Chinese Chemical Letters 2022年第12期33卷 5056-5060页

作者： Junyan Chen Dachang Bai Xiuli Guo Yiyao Wang Xingwei Li nmpa key laboratory for research and evaluation of innovative drug Collaborative Innovation Center of Henan Province for Green Manufacturing of Fine ChemicalsKey Laboratory of Green Chemical Media and ReactionsMinistry of EducationSchool of Chemistry and Chemical EngineeringHenan Normal UniversityXinxiang 453007China State key laboratory of Organometallic Chemistry Shanghai Institute of Organic ChemistryChinese Academy of SciencesShanghai 200032China School of Chemistry and Chemical Engineering Shaanxi Normal University(SNNU)Xi'an 710062China

Ni(0)-catalyzed regio-and diastereodivergent[4+2]annulation of biphenylenes withα,βunsaturated ketones is described.This solvent-controlled diastereodivergent reaction integrates C-C bond cleavage of biphenylene and C=C double bond insertion selectivity,offering a mild approach to all possible diastereoisomers of 9,10-dihydrophenanthrene derivatives from the same starting materials.

关键词： Nickel Enones Biphenylenes Diastereodivergent annulation C-C activation 9,10-Dihydrophenanthrenes

MACS-W:A modified optical clearing agent for imaging 3D cell cultures

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Journal of innovative Optical Health Sciences 2024年第2期17卷 24-34页

作者： Xiang Zhong Chao Gao Hui Li Yuening He Peng Fei Zaozao Chen Zhongze Gu Dan Zhu Tingting Yu Britton Chance Center for Biomedical Photonics-MoE key laboratory for Biomedical Photonics Huazhong University of Science and Technology Wuhan Hubei 430074P.R.China Wuhan National laboratory for Optoelectronics-Advanced Biomedical Imaging Facility Huazhong University of Science and Technology Wuhan Hubei 430074P.R.China School of Optical and Electronic Infrmation Huazhong University of Science and Technology Wuhan Hubei 430074P.R.China State key laboratory of Bioelectronics School of Biological Science and Medical Engineering Southeast University NanjingJiangsu 210096P.R.China Institute of Biomaterials and Medical Devices Southeast University Suzhou Jiangsu 215163P.R.China

Three-dimensional(3D)cell cultures have contributed to a variety of biological research fields by filling the gap between monolayers and animal models.The modern optical sectioning microscopic methods make it possible to probe the complexity of 3D cell cultures but are limited by the inherent opaqueness.While tissue optical clearing methods have emerged as powerful tools for investigating whole-mount tissues in 3D,they often have limitations,such as being too harsh for fragile 3D cell cultures,requiring complex handling protocols,or inducing tissue deformation with shrinkage or expansion.To address this issue,we proposed a modified optical clearing method for 3D cell cultures,called MACS-W,which is simple,highly efficient,and morphology-preserving.In our evaluation of MACS-W,we found that it exhibits excellent clearing capability in just 10 min,with minimal deformation,and helps drug evaluation on tumor spheroids.In summary,MACS-W is a fast,minimally-deformative and fluorescence compatible clearing method that has the potential to be widely used in the studies of 3D cell cultures.

关键词： Tissue optical clearing 3D cell cultures imaging

Design and characterizing of robust probes for enhanced mass spectrometry imaging and spatially resolved metabolomics

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Chinese Chemical Letters 2023年第5期34卷 397-402页

作者： Jianpeng Huang Shanshan Gao Kai Wang Jin Zhang Xuechao Pang Junwen Shi Jiuming He State key laboratory of Bioactive Substance and Function of Natural Medicines Institute of Materia MedicaChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100050China nmpa key laboratory of Safety research and evaluation of innovative drug Institute of Materia MedicaChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100050China Viktor Technology Co. Ltd.Beijing 101100China

As for the emerging and cut edge spatially resolved metabolomics,mass spectrometry imaging(MSI)is a powerful tool that can map thousands of metabolites from bio-tissue sections without chemical labels.However,the stability,sensitivity and spatial resolution of MSI are always limited by the performance of its ionization probe.Herein,two types of probes(fine probe(P-100)and large probe(P-200))were designed and characterized to perform air-flow assisted desorption electrospray ionization(AFA-DESI)MSI analysis for spatially resolved metabolomics.It was determined that the spray introduced by P-100 was homogenous and stable under the spray solvent at a flow rate of 5-10μL/min,while P-200 can endure a high flow rate of up to 10-30μL/min.Moreover,the MSI images were acquired by AFA-DESI-MSI with P-100 from rat brain tissue section and with P-200 from whole-body tissue section of mouse,and these results presented unambiguous tissue structure with the distribution information of numerous metabolites.Furthermore,the spatially resolved metabolomic analysis of tumor tissue was successfully realized to discover the tumor associated biomarkers.As the key parts of AFA-DESI-MSI system,it has been demonstrated that the designed probs have excellent performance for spatially resolved metabolomics,and it will further promote its application in life science,and drug research and development.

关键词： Air-flow assisted desorption electrospray ionization Mass spectrometry imaging Molecular imaging Spatially resolved metabolomics Brain

Localized delivery of nanomedicine and antibodies for combating COVID-19

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Acta Pharmaceutica Sinica B 2023年第5期13卷 1828-1846页

作者： Bin Tu Yanrong Gao Xinran An Huiyuan Wang Yongzhuo Huang State key laboratory of drug research Shanghai Institute of Materia MedicaChinese Academy of SciencesShanghai 201203China University of Chinese Academy of Sciences Beijing 100049China University of Michigan College of Pharmacy Ann ArborMI 48109USA Zhongshan Institute for drug Discovery SIMMCASZhongshan 528437China nmpa key laboratory for Quality research and evaluation of Pharmaceutical Excipients Shanghai 201203China Taizhou University School of Advanced StudyInstitute of Natural Medicine and Health ProductTaizhou 318000China

The severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)pandemic has been a major health burden in the world.So far,many strategies have been investigated to control the spread of COVID-19,including social distancing,disinfection protocols,vaccines,and antiviral treatments.Despite the significant achievement,due to the constantly emerging new variants,COVID-19 is still a great challenge to the global healthcare system.It is an urgent demand for the development of new therapeutics and technologies for containing the wild spread of SARS-CoV-2.Inhaled administration is useful for the treatment of lung and respiratory diseases,and enables the drugs to reach the site of action directly with benefits of decreased dose,improved safety,and enhanced patient compliance.Nanotechnology has been extensively applied in the prevention and treatment of COVID-19.In this review,the inhaled nanomedicines and antibodies,as well as intranasal nanodrugs,for the prevention and treatment of COVID-19 are summarized.

关键词： SARS-CoV-2 COVID-19 Nanomedicine Orally-inhaled delivery Intranasal delivery Antibody