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A bivalent recombinant vaccine:a promising strategy against both SARS-CoV-2 variants and wild type of the virus

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Signal Transduction and Targeted Therapy 2021年第8期6卷 2266-2267页

作者： Junzhi Wang Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products National Institutes for Food and Drug ControlBeijingChina

A recent study published in Medcomm by He et al.1 introduced protein subunit vaccines with wild-type and mutant S1 subunit(S1-WT and S1-Mut)of severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)to evaluate their immunoprotective *** team further analyzed the neutralization activity of bivalent vaccine composed of S1-WT and S1-Mut for SARS-CoV-2 and mutant strains to explore a universal protective vaccine.

关键词： protective vaccine

Insights into Euphorbia diversity: Probing the contrasts between Euphorbia fischeriana Steud and Euphorbia ebracteolata Hayata

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Journal of Pharmaceutical Analysis 2024年第5期14卷 775-779页

作者： Kaicheng Du Yi Zhang Lei Sun Muke Tao Tiantian Zuo Yumeng Wang Zhengfeng Zhang Dali Meng School of Traditional Chinese Materia Medica Shenyang Pharmaceutical UniversityShenyang110016China NMPA Key Laboratory for Quality Monitoring of Narcotic drugs and Psychotropic Substances Chongqing Institute for Food and Drug ControlChongqing401121China national institutes for food and drug control Beijing100050China

In traditional Chinese medicine(TCM),Euphorbia fischeriana Steud(***)and Euphorbia ebracteolata Hayata(***),commonly referred to as“Langdu”,are widely extensively utilized for treating lymphatic tuberculosis and ringworm[1].Both plant species are perennial herbaceous plants mainly distributed in northeastern China,Mongolia,Russia(Siberia),and Republic of Korea[2].There have been many reports on the chemical constituents and pharmacological effects of the two plant species,which has made more and more researchers realize that there may be differences between *** and *** some cases,long-term improper use of herbal medicines can even lead to life-threatening conditions[3,4].Therefore,it is essential to employ an effective technology to differentiate between these two plants based on their chemical constituents and biological activities,so as to reduce the harm caused by the mixing and misuse of medicinal ***,the present paper describes a study of the differences between *** and ***,using untargeted plant metabolomics and biological activity *** study aims to provide valuable insight into their equivalence and potential interchangeability in TCM and clinical medication.

关键词： Euphorbia Siberia northeastern

Investigation into the structures and physicochemical properties of multi-component crystals of voriconazole

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Chinese Chemical Letters 2023年第6期34卷 504-511页

作者： Hong-Mei Yu Bao-Xi Zhang Wen-Hui Xing Mei-Ju Liu Feng-Feng Wang Ning-Bo Gong Li Zhang Yang Lu Guan-Hua Du beijing Key Laboratory of Polymorphic drugs Institute of Materia MedicaChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100050China national institutes for food and drug control Beijing 102629China beijing City Key Laboratory of drug Target Identification and drug Screening Institute of Materia MedicaChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100050China

Voriconazole(VZL)is a second-generation and broad-spectrum triazole against fungal *** a BCS(biopharmaceutics classification system)class II compound,the poor aqueous solubility has limited its bioavailability and clinical *** to overcome this disadvantage,a cocrystallization strategy based on crystal engineering principles has resulted in five new multi-component crystals of VZL with maleic acid,L-tartaric,protocatechuic,gallic,and 3,5-dinitrobenzoic *** analysis revealed that the hydroxyl/carboxylic acid···triazole N_(3)hydrogen bonding interaction appears as a main supramolecular heterosynthon in the VZL multi-component crystals with organic *** VZL molecule has a flexible conformation in each of the five multi-component *** newly synthesized multi-component crystals showed impressive solubility improvement compared to that of the raw material of *** electrostatic potential surfaces(MEPS)analysis based on density functional(DFT)calculations revealed that hydrogen bond interactions in cocrystals mainly involved pairwise interactions in the global maxima and minima sites,but this rule is not always *** study indicates the potential of cocrystals to improve the solubility and dissolution rate of VZL.

关键词： Multi-component crystal Voriconazole Solubility Dissolution Stability

Brief introduction for search and determination of the comparator product for generic medicinal product application in the EU

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Journal of Chinese Pharmaceutical Sciences 2018年第11期27卷 805-812页

作者： Jianzhao Niu Dongsheng Yang Mingdi Xu national institutes for food and drug control Beijing 100050China

It is vital segment to choose the right comparator product during the development and study of generic medicinal product, and this is also definitely specified in the relevant documents from the China food and drug Administration (CFDA)that the comparator product should be innovator product or internationally recognized same medicinal product,which is used in the re-evaluation of generic medicinal product or marketed authorization application of the generic medicinal *** facilitate the domestic and foreign pharmaceutical enterprises to choose and determine comparator product,four medicinal product evaluation procedures,as well as the corresponding marketed medicinal product list,are detailed elaborated in this *** the same time, by taking the Mifepristone Tablet (200mg)as example,the search and determination process of the comparator product for generic medicinal product application in the EU is illustrated with the combination of different marketed medicinal product lists.

关键词： Comparator product Re-evaluation of generic medicinal product Marketing authorization application Mifepristone tablet

A novel alternative for pyrogen detection based on a transgenic cell line

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Signal Transduction and Targeted Therapy 2024年第3期9卷 1221-1229页

作者： Qing He Chuan-Fei Yu Gang Wu Kai-Qin Wang Yong-Bo Ni Xiao Guo Zhi-Hao Fu Lan Wang De-Jiang Tan Hua Gao Can Wang Gang Chen Xu-Hong Chen Bo Chen Jun-Zhi Wang national institutes for food and drug control BeijingChina School of Life Science and Biopharmaceutics Shenyang Pharmaceutical UniversityShenyangChina Shanghai Institute for food and drug control ShanghaiChina KeyMed Biosciences Inc. ChengduChina

Pyrogen,often as a contaminant,is a key indicator affecting the safety of almost all parenteral drugs(including biologicals,chemicals,traditional Chinese medicines and medical devices).It has become a goal to completely replace the in vivo rabbit pyrogen test by using the in vitro pyrogen test based on the promoted‘reduction,replacement and refinement’principle,which has been highly considered by regulatory agencies from different *** used NF-κB,a central signalling molecule mediating inflammatory responses,as a pyrogenic marker and the monocyte line THP-1 transfected with a luciferase reporter gene regulated by NF-κB as an in vitro model to detect pyrogens by measuring the intensity of a fluorescence ***,we show that this test can quantitatively and sensitively detect endotoxin(lipopolysaccharide from different strains)and nonendotoxin(lipoteichoic acid,zymosan,peptidoglycan,lectin and glucan),has good stability in terms of NF-κB activity and cell phenotypes at 39 cell passages and can be applied to detect pyrogens in biologicals(group A&C meningococcal polysaccharide vaccine;basiliximab;rabies vaccine(Vero cells)for human use,freeze-dried;Japanese encephalitis vaccine(Vero cells),inactivated;insulin aspart injection;human albumin;recombinant human erythropoietin injection(CHO Cell)).The within-laboratory reproducibility of the test in three independent laboratories was 85%,80%and 80%and the interlaboratory reproducibility among laboratories was 83.3%,95.6%and 86.7%.The sensitivity(true positive rate)and specificity(true negative rate)of the test were 89.9%and 90.9%,*** summary,the test provides a novel alternative for pyrogen detection.

关键词： pyrogen rabbit replace

Brief introduction for application of the USA national drug code

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Journal of Chinese Pharmaceutical Sciences 2019年第3期28卷 203-208页

作者： Dongsheng Yang Lingyun Ma Jianzhao Niu Mingdi Xu national institutes for food and drug control Beijing 100050China

The reference listed drug (RLD) adopted in the USA orange book is the important source of the Chinese comparator product directories of generic medicinal products. Therefore, its availability has the vital significanee for pharmaceutical enterprise to carry out the re-evaluation of gen eric medici nal products and study of generic medicinal products. The nati onal drug code (NDC) is the unique, 3-segment number for each drug product in USA, and it serves as a universal product identifier for drugs. While the NDC directory adopts the infbrmation of drug products in the current commercial distribution, including all of the prescription drug and over the counter (OTC) drug products. The composition and configuration of the NDC number are systemically elaborated in this paper, as well as the data source, development history and supporting measures of the NDC directory. At the same time, by taking drugs, which are adopted in the Chinese comparator product directory of generic medicinal product (first batch) and sourced from USA orange book, as example, it introduces the application of the NDC directory in the availability aspect of the Chinese comparator products to facilitate the Chinese or foreign pharmaceutical manufacturers to search, identify and purchase the suitable RLD sourced from USA orange book. Moreover, it can provide referenee for Chinese drug regulatory to prepare the Chinese comparator product directories of generic medicinal products.

关键词： national drug code Comparator product Re-evaluation of generic medicinal product Orange book

Brief introduction for application of USA authorized generic drugs

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Journal of Chinese Pharmaceutical Sciences 2019年第6期28卷 439-445页

作者： Dongsheng Yang Lingyun Ma Jianzhao Niu Mingdi Xu national institutes for food and drug control Beijing 100050China

The authorized generic drugs(AGs)are drug products marketed in the USA with the permission of sponsor or holder of the approved brand name drug(usually refers to an innovator drug).Other than the fact that it does not have the brand name on its label,it is the exact same drug product as the brand name *** China,for those published comparator products of generic drug products,the market availability is the first question to affect the smooth development and investigation for the process of the re-evaluation of the generic *** the present paper,we systemically elaborated the definition,classification and relevant background of the AGs,as well as their differences to the generic *** the same time,by taking drug products,which are adopted in the Chinese comparator product directories for generic medicinal products(first batch)and sourced from USA orange book,as examples,we introduced the searching process of the AGs with the integration of FDA listing of AGs,the USA orange book and the USA national drug code *** can facilitate the domestic and foreign pharmaceutical enterprises to search,identify and purchase the corresponding AGs of the designated comparator product when question emerges to its market availability.

关键词： Authorized generic drugs New drug application national drug code Comparator product Re-evaluation of generic medicinal product Orange book

Cathepsin L plays a key role in SARS-CoV-2 infection in humans and humanized mice and is a promising target for new drug development

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Signal Transduction and Targeted Therapy 2021年第4期6卷 1357-1368页

作者： Miao-Miao Zhao Wei-Li Yang Fang-Yuan Yang Li Zhang Wei-Jin Huang Wei Hou Chang-Fa Fan Rong-Hua Jin Ying-Mei Feng You-Chun Wang Jin-Kui Yang Department of Endocrinology Beijing Tongren HospitalCapital Medical UniversityBeijingChina Division of HIV/AIDS and Sex-Transmitted Virus Vaccines Institute for Biological Product ControlNational Institutes for Food and Drug Control(NIFDC)BeijingChina Department of Science and Technology Beijing Youan HospitalCapital Medical UniversityBeijingChina Division of Animal Model Research Institute for Laboratory Animal ResourcesNational Institutes for Food and Drug ControlBeijingChina

To discover new drugs to combat COVID-19,an understanding of the molecular basis of SARS-CoV-2 infection is urgently ***,for the first time,we report the crucial role of cathepsin L(CTSL)in patients with *** circulating level of CTSL was elevated after SARS-CoV-2 infection and was positively correlated with disease course and ***,SARS-CoV-2 pseudovirus infection increased CTSL expression in human cells in vitro and human ACE2 transgenic mice in vivo,while CTSL overexpression,in turn,enhanced pseudovirus infection in human *** functionally cleaved the SARS-CoV-2 spike protein and enhanced virus entry,as evidenced by CTSL overexpression and knockdown in vitro and application of CTSL inhibitor drugs in ***,amantadine,a licensed anti-influenza drug,significantly inhibited CTSL activity after SARS-CoV-2 pseudovirus infection and prevented infection both in vitro and in ***,CTSL is a promising target for new anti-COVID-19 drug development.

关键词： infection drugs ACE2

Study on a noninvasive method for rapid screening Human Serum albumin injectables by Raman spectroscopy

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Journal of Innovative Optical Health Sciences 2017年第1期10卷 34-42页

作者： Yu Zhao Nan Ji Xiuji Li Jifeng Hou Min Li Yongjian Yang Ping Tian Xinmei Sun Xinyue Xiao Lihui Yin national institutes of food and drug control(NIFDC)No.2 Tiantan Xi Li BeijingP.R.China tSichuan Vspec Technologies Co.Ltd.Beijing Office No.2 BeiTaiPingZhuang RoadBeijingP.R.China Shanghai Institute for food and drug control(SIFDC)No.1500 Zhangheng road ShanghaiP.R.China

Human serum albumin(HSA)injectable product is a severely afflicted area on drug safety due to its high price and restricted *** spectroscopy performances high specificity on HSA detection and it is even possible to determine HSA injectable products *** this study,we developed a noninvasive rapid screening method for of HSA injectable products by using portable Raman *** models were established by using principal component analysis combined with classical least squares(PCA-CLS)algorithm,while quanti-tative model was established by using partial least squares(PLS)*** transfer in different instruments of both the same and different apparatus modules was further discussed in this paper.A total of 34 HSA injectable samples collected from markets were used for *** identification results showed 100%accuracy and the predicted concentrations of those identified as true HSA were consistent with their labeled *** quantitative results also indicated that model transfer was excellent in the same apparatus modules of Raman spectrometer at all concentration levels,and still good enough in the different apparatus modules although the relative standard deviation(RSD)value showed a little increasing trend at low HSA concentration *** conclusion,the method was proved to be feasible and efficient for screening HSA injections,especially on its screening speed and the consideration of glass ***,with inspiring results on the model transfer,the method could be used as a universal screening mean to different Raman instruments.

关键词： Human serum albumin Raman noninvasive rapid screening method principal component analysis combined with classical least squares partial least squares model transfer.