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A holistic strategy for quality and safety control of traditional Chinese medicines by the “iVarious” standard system

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Journal of Pharmaceutical Analysis 2017年第5期7卷 271-279页

作者： Anzhen Chen Lei Sun Hang Yuan Aiying Wu Jingguang Lu Shuangcheng Ma Qingdao Institute for food and drug Control National Institutes for food and drug Control Xinjiang Institute for food and drug Control

An effective quality control system is the key to ensuring the quality, safety and efficacy of traditional Chinese medicines(TCMs). However, the current quality standard research lacks top-level design and systematic design,mostly based on specific technologies or evaluation methods. To resolve the challenges and questions of quality control of TCMs, a brand-new quality standard system, named "iVarious", was proposed. The system comprises eight elements in a modular format. Meaning of every element was specifically illustrated via corresponding research instances. Furthermore, frankincense study was taken as an example for demonstrating standards and research process, based on the "i Various" system. This system highlighted a holistic strategy for effectiveness,security, integrity and systematization of quality and safety control standards of TCMs. The establishment of"i Various" integrates multi-disciplinary technologies and progressive methods, basis elements and key points of standard construction. The system provides a novel idea and technological demonstration for regulation establishment of TCMs quality standards.

关键词： iVarious Quality standard system Traditional Chinese medicines (TCMs) Quality and safety control Holistic strategy

Analysis on Volatile Constituents in Leaves and Fruits of Ficus carica by GC-MS

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Chinese Herbal Medicines 2012年第1期4卷 63-69页

作者： Jun LI[a][b] Yu-zeng TIAN[a] Bao-ya SUN[c] Dan YANG[d] Ji-ping CHEN[a] Qi-ming MEN[b] dalian Institute of Chemical Physics Chinese Academy of Sciences Dalian 116023 China dalian Institute for food and drug Control Dalian 116021 China

Objective To identify and analyze the volatile constituents in the leaves and fruits of Ficus carica. Methods Gas chromatography (GC) and gas chromatography-mass spectrometry (GC-MS) were used. Results The major components detected in volatile oil of the leaves were psoralen (10.12%), β-damascenone (10.17%), benzyl alcohol (4.56%), behenic acid (4.79%), and bergapten (1.99%), etc. The major components detected in volatile oil of the fruits were furfural (10.55%), 5-methyl-2-furaldehyde (10.1%), and benzeneacetaldehyde (6.59%), etc. Conclusion A total of 121 volatile constituents are identified in the leaves and 108 in the fruits of F. carica, among which 103 constituents are identified for the first time in the leaves and 100 in the fruits. Eighteen volatile constituents are identified in both leaves and fruits.

关键词： bergapten Ficus carica GC GC-MS psoralen volatile oils

Discovery of New Iridoids as Farnesoid X Receptor Agonists from Morinda officinalis: Agonistic Potentials and Molecular Stimulation

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Chinese Journal of Chemistry 2021年第5期39卷 1288-1296页

作者： Zhi-Lin Luan Fei Qiao Wen-Yu Zhao Wen-Hua Ming Zhen-Long Yu Jie Liu Sheng-Yun Dai Shuang-Hui Jiang Chao-Jie Lian Cheng-Peng Sun Bao-Jing Zhang Jian Zheng Shuang-Cheng Ma Xiao-Chi Ma dalian Key Laboratory of Metabolic Target Characterization and Traditional Chinese Medicine Intervention College of PharmacyCollege of Integrative MedicineDalian Medical UniversityDalianLiaoning 116044China National Institutes for food and drug Control Beijing 102629China

The investigation of Morinda officinalis led to the isolation of twelve compounds(1-12),including three new iridoid glycosides morindallns A-C(1-3)and nine known compounds(4-12).Their structural identifications were conducted using HRMS,1D and 2D NMR,and electronic circular dichroism(ECD)spectra as well as quantum chemical *** 6 displayed the most significantly agonistic activity against farnesoid X receptor(FXR)with an EC_(50) value of 7.18 μM,and its agonistic effect was verified through the investigation of FXR downstream target genes including small heterodimer partner 1(SHP1),bile salt export pump(BSEP),and organic solute transporter subunit alpha and beta(OSTα and OSTβ).The potential interaction of compound 6 with FXR was analyzed by molecular docking and molecular dynamics stimulation,revealing that amino acid residues Leu287;Thr288,and Ser332 played a crucial role in the activation of compound 6 towards *** findings suggested that compound 6 could be regarded as a potential candidate for the development of FXR agonists.

关键词： Morinda officinalis Iridoid Farnesoid X receptor Agonistic effect

Microwave-assisted Solid-phase Synthesis, Biological Evaluation and Molecular Docking of Angiotensin I-converting Enzyme Inhibitors

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Chemical Research in Chinese Universities 2012年第1期28卷 108-113页

作者： SUN Yang1, HUANG Da-wei1, LI Xiao-hui1, HU Jian-en2 and XIU Zhi-long1 1. School of Life Science and Biotechnology, dalian University of Technology, dalian 116024, P. R. China 2. School of food Engineering, dalian Ocean University, dalian 116023, P. R. China School of Life Science and Biotechnology Dalian University of Technology Dalian 116024 School of food Engineering Dalian Ocean University Dalian 116023

Short peptides based on the tripeptides, Leu-Arg-Pro and Leu-Lys-Pro, were synthesized by microwave assisted solid-phase synthesis method, in order to make a search for potential inhibitors for angiotensin I-converting enzyme（ACE） with minimum side effects in the treatment of hypertension. One peptide with the sequence Leu-Arg-Pro-Phe-Phe shows the strongest inhibition towards ACE with an IC50 value of 0.26 μmol/L in vitro. The study of structure-activity relationship shows that the introduction of a bulky group into the N-terminal of this series of inhibitors may enlarge steric hindrance, resulting in the poor inhibitory activity towards ACE. The inhibitory activity decreased in turn when L-Pro, D-Pro or Ac6c was at the C-terminal respectively. The binding interaction between each of these inhibitors and testicular ACE（tACE） was performed by molecular docking. The results suggest that Leu-Arg-Pro-Phe-Phe mainly occupied the S1 subsite of tACE, and made contact with tACE via seven H-bonds. It appeared that the site on the peptide that bound with tACE was influenced by the configuration of the amino acid, L or D-form, at the C-terminal of the peptide.

关键词： Angiotensin I-converting enzyme Peptide inhibitor Molecular docking Microwave-assisted solid-phasesynthesis

A Dinuclear Cd(Ⅱ)Cluster-based Coordination Polymer:Synthesis,Structure and Luminescence Property

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Chinese Journal of Structural Chemistry 2018年第1期37卷 119-124页

作者：薛丽平 College of food and drug Luoyang Normal University

One two-dimensional coordination polymer with a formula of {[Cd（L）（imidazole）（H2O）]（H2O）}n（1） was obtained by the synthetic reactions in aqueous solution using a newly synthesized H2L（H2L = methyl-3-hydroxy-5-carboxy-2-thiophenecarboxylate） ***1 crystallizes in monoclinic system,space group C2/c with a = 18.3176（11）,b = 8.5366（9）,c =8.4152（5）A,β = 101.789（6）°,V = 2797.1（3）A^3,Dc = 1.979 g/cm^3,C（10）H（12）N2O7SCd,Mr = 416.68 F（000） = 1648,μ = 1.745 mm^-1,F（000） = 1648,the final R = 0.0323 and wR = 0.0604 for 2604 observed reflections with I 〉 2s（I）.Structure analyses reveal that the compound is constructed by dinuclear Cd（Ⅱ） clusters bridged by two hydroxyl oxygens of L^2-anions,which features a two-dimensional network with 4-connected sql ***,the compound exhibits high thermal stability and intense fluorescent emission,and could be explored for potentia luminescent materials.

关键词： methyl-3-hydroxy-5-carboxy-2-thiophenecarboxylate topology luminescence property

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

Evaluation of silymarin extract from Silybum marianum in mice: anti-fatigue activity

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food Science and Human Wellness 2022年第4期11卷 914-921页

作者： Luming Jia Fei Zhao College of food Science and Engineering Dalian Ocean UniversityDalian 116023China

Silymarin has been used for centuries for its hepatoprotective properties. The specific objective of this study was to evaluate the anti-fatigue properties of silymarin. The silymarin was administered orally at doses of 50, 100, and 200 mg/kg for 4 weeks;the fatigue level and exercise performance were evaluated using exhaustive swimming time and pole-climbing time, as well as levels of plasma lactate, ammonia, glucose, creatine kinase(CK), serum urea nitrogen(SUN), blood lactic acid(BLA), muscle glycogen(MG), and liver glycogen(LG) contents after an intensive swimming session. The results demonstrated that silymarin treatment decreased the BLA and SUN levels while increased the LG and MG levels. In addition, silymarin decreased plasma lactate and ammonia levels and CK activity after swimming test, this is related to the mechanism that increases energy storage(as glycogen) and release(as blood glucose), and decreases plasma levels of lactate, ammonia, and CK. The observation of the skeletal muscle structures of mice also confirmed that skeletal muscles became more damaged in the control group compared with the silymarin-treated mice after prolonged endurance exercise. Therefore, it is reasonable to infer that silymarin may bear potential pharmacological effects in combating fatigue.

关键词： Silybum marianum Silymarin Anti-fatigue Exhaustion exercise

Visualization of the protective role of estrogen against female liver fibrosis via an ER viscosity NIR fluorescent probe

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Science China Chemistry 2025年第1期 360-368页

作者： Zheng Liu Changyu Zhang Zipeng Li Wanying Ma Jia Liu Xiang Xia Ning Xu Wen Sun Jianjun Du Jiangli Fan Xiaojun Peng State Key Laboratory of Fine Chemicals Dalian University of Technology Ningbo Institute of dalian University of Technology

Endoplasmic reticulum(ER) viscosity has emerged as a new potential biomarker for hepatic fibrosis(HF). Herein, we report the first ER-targeting viscosity-responsive near-infrared(NIR) fluorescent probe HBT-PP for investigations of HF *** twisted intramolecular charge transfer(TICT) and the excited state intramolecular proton transfer(ESIPT) are combined to endow HBT-PP with the selective response towards viscosity(～62-fold) and a super large stokes shift(～320 nm). HBT-PP mainly targets organelle ER and is able to image the drug-or alcohol-induced viscosity elevation in living cells. Significantly,HBT-PP was successfully applied to visualize the gender difference in HF and the protective role of estrogen in restraining HF progression. Of note, after 10 min of stain with HBT-PP, HF lesions showed a stage-based response, indicating the potential of this probe in fast and early diagnosis of HF. These results clearly demonstrated the promising application of HBT-PP as a new tool for exploring ER viscosity-involved physiological and pathological processes.

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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