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Disease-based Toxicology on Safety Assessment Strategy and Application for Herbal and Traditional Medicines

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World Journal of Traditional Chinese Medicine 2019年第3期5卷 139-144页

作者： jia-bo wang Zhuo Shi Xiao-He Xiao The Fifth Medical Center China Military Institute of Chinese MedicineGeneral Hospital of PLA Clinical Pharmacokinetics Laboratory School of Basic Medicine and Clinical PharmacyChina Pharmaceutical UniversityNanjingChina Integrative Medical Center The Fifth Medical CenterGeneral Hospitalof PLABeijing

The safety issue on herbal and traditional medicines(H&TM) is one of the most challenging problems and serious concern worldwide. With scientific endeavor and further exploration, we came to realize that there are great differences between H&TM and synthetic drugs in many aspects, such as medical theory, medication experience, compatibility, processing, toxicological characteristics, and safety evaluating requirements. In the current preclinical models for synthetic drugs, the safety assessment results of some conventional deemed 'nontoxic' H&TM were not well consistent with clinical situations, which resulted in major difficulties to understand the mechanisms and guide the safe and rational uses of these H&TM. Thus, based on the traditional Chinese medicine toxicity theory called You Gu Wu Yun, this paper introduces a novel safety assessment strategy for H&TM, named as disease-based toxicology. It aims to cognize the relativity and susceptibility of the toxicity of H&TM, and then to enhance controllability in new drug development and clinical applications. It also provides a theoretical practice for the traditional Chinese medicine toxicity theory and a methodological promotion for the future development of the precision toxicology for H&TM.

关键词： Disease-based toxicology idiosyncratic toxicity safety of herbal and traditional medicines susceptibility syndrome differentiation-based toxicity attenuation

Biopotency Assays:an Integrated Application to Quality Control of Chinese Materia Medica

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Chinese Herbal Medicines 2014年第4期6卷 256-264页

作者： Yin Xiong Dan Yan jia-bo wang Xiao-he Xiao China Military Institute of Chinese Materia Medica 302 Military Hospital of China School of Chinese Materia Medica Beijing University of Chinese Medicine

The current quality control（QC） pattern for Chinese materia medica（CMM） lacks suitable methods and indicators to evaluate their safety and efficacy effectively, which impedes the smooth development of CMM. In this review, main problems of the current QC pattern for CMM, principally focused on the content determination of constituents,were summarized and the inspiration from the QC of biological products was introduced. With the aim at introducing a suitable tool to the QC of CMM, biopotency assay and its feasibility in the QC pattern for CMM were analyzed and confirmed by relevant researches with years of practice. From the applications of biopotency assays in the QC of CMM in the last 10 years, we propose that biopotency assays should be an integral part of the QC pattern for CMM, for these assays can make the QC indicators related to the clinical safety and efficacy, supplementing the existed QC system of CMM.

关键词： biopotency assays Chinese materia medica efficacy indicator quality controlbiopotency assays Chinese materia medica efficacy indicator quality controlbiopotency assays Chinese materia medica efficacy indicator quality controlbiopotency assays Chinese materia medica efficacy indicator quality control

Green tea polyphenol, epigallocatechin-3-gallate, possesses the antiviral activity necessary to fight against the hepatitis B virus replication in vitro

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Journal of Zhejiang University-Science B(Biomedicine & Biotechnology) 2014年第6期15卷 533-539页

作者： Jing-yao PANG Kui-jun ZHAO jia-bo wang Zhi-jie MA Xiao-he XIAO Clinical Pharmacy Laboratory Beijing Friendship Hospital Capital Medical University China Military Institute of Chinese Medicine 302 Military Hospital Integrative Medicine Center 302 Military Hospital

Although several antiviral drugs and vaccines are available for use against hepatitis B virus （HBV）, hepatitis caused by HBV remains a major public health problem worldwide, which has not yet been resolved, and new anti-HBV drugs are in great demand. The present study was performed to investigate the anti-HBV activity of epigallocatechin- 3-gallate （EGCG）, a natural-origin compound, in HepG2 2.2.15 cells. The antiviral activity of EGCG was examined by detecting the levels of HBsAg and HBeAg in the supematant and extracellular HBV DNA. EGCG effectively suppressed the secretion of HBsAg and HBeAg from HepG2 2.2.15 cells in a dose- and time-dependent manner, and it showed stronger effects at the level of 0.11-0.44 pmol/ml （50-200 μg/ml） than lamivudine （3TC） at 0.87 μmol/ml （200 pg/ml）. EGCG also suppressed the amount of extracellular HBV DNA. The data indicated that EGCG possessed anti-HBV activity and suggested the potential of EGCG as an effective anti-HBV agent with low toxicity.

关键词： Epigallocatechin-3-gallate Hepatitis B virus (HBV) Antiviral activity HepG2 2.2.15 Lamivudine

Spectrum-Toxicity Correlation Study Revealed the Influence of the Nine-Time Steaming and Sun Drying Method on Hepatotoxic Components of Polygoni Multiflori Radix

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World Journal of Traditional Chinese Medicine 2021年第2期7卷 227-233页

作者： Zhuo Shi Xiao-Fei Li Ya-Lei Liu Peng-Yan Li Ming Niu Zhao-Fang Bai Guang-Qin Zhang Yang Lu jia-bo wang Clinical Pharmacokinetics Laboratory School of Basic Medicine and Clinical PharmacyChina Pharmaceutical UniversityNanjing The Fifth Medical Center China Military Institute of Chinese MedicineGeneral Hospital of PLABeijingChina

Objective:Polygoni Multiflori Radix(PM)is a traditional herbal medicine with repeated reports of liver injury events in recent *** wondered whether the classical processing method,namely,nine-time steaming and sun drying(NSSD),had toxicity-attenuating effects on PM and the relationships between toxicity and times of processing,as well as with the alteration trends of its *** and Methods:The chemical fingerprints of different PM extracts were developed using ultra-high-performance liquid *** spectrum-toxicity correlation between the chemical fingerprints and hepatocellular toxicity was analyzed with multiple correlation ***:The results suggested that the hepatotoxicity of NSSD processing products markedly decreased with the repeated steaming and sun drying,which was obviously superior to the product processed by the modern *** analysis revealed that the contents of cis-stilbene glycoside and emodin-8-O-β-D-glucoside related to liver injury susceptibility were reduced with the times of NSSD processing,which was consistent with the decreased trend of hepatocellular *** the five times of NSSD,the contents of them as well as the hepatotoxicity of PM were ***,we found that the contents of catechin and physcion declined rapidly after the one time of NSSD and then remained stable until the nine times of *** on the fact,they could be utilized to indicate whether PM products were processed by steaming and sun ***:This paper confirmed that the NSSD had a good influence on the toxicity attenuating to PM and found four compounds which could apply for the quality control of PM.

关键词： Hepatotoxicity nine-time steaming and sun drying polygoni multiflori radix spectrum-toxicity correlation toxicity attenuation by processing

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水下目标宽带回波特性的快速计算方法

上海交通大学学报 2017年第2期51卷 224-228页

作者：贾波王斌范军张培珍上海交通大学高新船舶与深海开发装备协同创新中心海洋工程国家重点实验室上海200240 广东海洋大学信息学院广东湛江524088

基于传统板块元方法,运用切比雪夫多项式插值实现了水下目标宽带回波特性的快速计算.从散射声场的特性出发,将幅相分离的思想引入散射声场的分析.目标表面单个板块散射声场可分解为随频率变化的快速起伏和缓变函数的乘积,提取缓变函数... 详细信息

基于传统板块元方法,运用切比雪夫多项式插值实现了水下目标宽带回波特性的快速计算.从散射声场的特性出发,将幅相分离的思想引入散射声场的分析.目标表面单个板块散射声场可分解为随频率变化的快速起伏和缓变函数的乘积,提取缓变函数切比雪夫节点处的板块散射声场,再利用切比雪夫逼近理论插值得到宽频带内各频率点处的精密计算.结合分离出的随频率快速起伏项,获取每个板块的宽带散射声场,通过各板块元散射声场叠加得到目标宽带回波特性.该方法避免了传统板块元算法逐频率点计算所带来的大量板块的重复计算,可以快速、精确计算水下目标宽带回波特性,计算效率大为提高.

关键词：板块元散射声场切比雪夫多项式宽带回波特性

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预混气爆震管中爆燃到爆震转捩距离的研究

推进技术 2003年第1期24卷 63-66页

作者：韩启祥王家骅王波南京航空航天大学能源与动力学院江苏南京210016

为了获得预混气爆震管中爆燃到爆震转捩 (DDT)距离的变化规律 ,进行了一系列的单循环爆震试验 ,其中预混气为按化学恰当比配制的乙炔与氧气以及稀释剂氮气 ,变化的试验参数包括 :预混气初始压力 (0 0 2MPa～ 0 1MPa)、稀释剂的浓度 (... 详细信息

为了获得预混气爆震管中爆燃到爆震转捩 (DDT)距离的变化规律 ,进行了一系列的单循环爆震试验 ,其中预混气为按化学恰当比配制的乙炔与氧气以及稀释剂氮气 ,变化的试验参数包括 :预混气初始压力 (0 0 2MPa～ 0 1MPa)、稀释剂的浓度 (0 %～ 70 % )及三种扰流片的形状。试验测得了不同工况下爆震管内火焰传播速度 ,并由此确定了DDT距离及其变化规律。试验结果表明 ,预混气初始压力下降或稀释剂浓度增加时 ,DDT距离增大。

关键词：爆燃到爆震转捩脉冲爆震发动机火焰传播爆震试验 DDT距离

The Green Tea Polyphenol,Epigallocatechin-3-gallate,Possesses the Antiviral Activity Necessary to Fight Against the Hepatitis B Virus Replication In Vitro

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The Green Tea Polyphenol,Epigallocatechin-3-gallate,Possesse...

Chemical Composition and Heavy Metal Content of Radix Notoginseng from Different Sources

第十四届全国中药和天然药物学术研讨会

作者： Jing-yao Pang jia-bo wang Zhi-jie Ma Kui-jun Zhao Xiao-he Xiao 302 Military Hospital

＜正＞Although several antiviral drugs and vaccines are available for use against hepatitis B virus（HBV）,hepatitis caused by HBV remains a major public health problem worldwide that has not yet been resolved,and new...

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Chemical Composition and Heavy Metal Content of Radix Notogi...

Needle-free injection of insulin powder: delivery efficiency and skin irritation assessment

第十四届全国中药和天然药物学术研讨会

作者： Lin-Lin Chen Xin Zhou Yi-Xuan Zhang jia-bo wang Xiao-He Xiao Yung-Chi Cheng Yale University School of Medicine HuBei University of Chinese Medicine Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine Shenyang Pharmaceutical University 302 Hospital of People's Liberation Army

＜正＞Panax notoginseng is traditionally cultivated in Wenshan and Baise *** resource ts becoming a serious issue because of succession cropping *** over 80%planting soil in Wenshan area is no more suitable for the co...

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Journal of Zhejiang University-Science B(Biomedicine & Biotechnology) 2014年第10期15卷 888-899页

作者： Chun-yu LI Zhe-wei wang Can TU jia-bo wang Bing-qian jiaNG Qi LI Ling-na ZENG Zhi-jie MA Ping ZHANG Yan-ling ZHAO Ya-ming ZHANG Dan YAN Rui TAN Xiao-he XIAO School of Pharmacy Chengdu University of Traditional Chinese Medicine China Military Institute of Chinese Medicine 302 Military Hospital School of Life Science and Engineering Southwest Jiaotong University School of Pharmacy Hunan University of Traditional Chinese Medicine Department of Traditional Chinese Medicine Beijing Friendship Hospital of Capital Medical University Integrative Medicine Center 302 Military Hospital

Insulin is widely used in treating diabetes, but still needs to be administered by needle injection. This study investigated a new needle-free approach for insulin delivery. A portable powder needleless injection（PNI） device with an automatic mechanical unit was designed. Its efficiency in delivering insulin was evaluated in alloxan-induced diabetic rabbits. The skin irritation caused by the device was investigated and the results were analyzed in relation to aerodynamic parameters. Inorganic salt-carried insulin powders had hypoglycemic effects, while raw insulin powders were not effective when delivered by PNI, indicating that salt carriers play an important role in the delivery of insulin via PNI. The relative delivery efficiency of phosphate-carried insulin powder using the PNI device was 72.25%. A safety assessment test showed that three key factors（gas pressure, cylinder volume, and nozzle distance） were related to the amount of skin irritation caused by the PNI device. Optimized injection conditions caused minimal skin lesions and are safe to use in practice. The results suggest that PNI has promising prospects as a novel technology for delivering insulin and other biological drugs.

关键词： Powder needleless injection Insulin Transdermal drug delivery Skin irritation