Valuable model for clinical trail-System Toxicological Studies on Active Components in derivatives of Lei-Gong-Teng from Traditional Chinese Medicines
文献类型：会议论文
| 作者 | Ren J(任进)
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| 出版日期 | 2016-09-11 |
| 关键词 | Valuable model for clinical trail-System Toxicological Studies on Active Components in derivatives of Lei-Gong-Teng from Traditional Chinese Medicines |
| 页码 | 3 |
| 英文摘要 | The present new trend in development of international innovative drug is more focused on how to transform laboratory research into clinical applications, which brings new requirements and challenges to the study of drug toxicology. The most important concept of translational medicine is a sizable boost for development of new drugs and clinical applications.Concerns of the international drug safety evaluation research and development, with particular emphasis on exploration and toxicity biomarker discovery, early prediction of liver, kidney, heartand other important toxic target organs; emphasize the introduction of "the fail early and cheaply"concept, the establishment of early toxicity screening systems, perform drug toxicity screening for lead compounds in the discovery phase, reducing the risk of drug development; vigorously we should promote the establishment of new, alternative, reduction of animals, short test cycle and cost less toxicity evaluation methods to reduce drug development costs; application of new molecular biology techniques,the establishment of a humanized mouse model,reducing species differences,more reliable extrapolation to man. This report is based on molecular mechanism of traditional Chinese medicine Lei-Gong-Teng derivatives, focus on its translation from basic science into clinical application of innovative drugs for specific instances. Lei-Gong-Teng derivative is an outstanding representative in a treasure house of Chinese medicine for the treatment of autoimmune and inflammatory diseases for several centuries. The main active ingredient is triptolide(TL) within diterpene esters(triptolide glycosides tablet), and is widely significant and long-term used in clinical efficacy. However, the clinical use of TL is limited by its narrow therapeutic window and toxic,such as the digestive tract, urinary tract,blood, bone marrow and reproductive system damage. For a long time,although it has some studies,its specific organ toxicity, metabolic characteristics, molecular mechanisms, particularly the specific testicular toxicity and molecular mechanism is still not clear. The study is to research the toxic effects of Lei-Gong-Teng derivatives with different target organs and molecular mechanisms and using transgenic and gene knockout animal models clearly requested by FDA, adopt the approach of modem molecular biology and new method for !H-NMR metabolomics, from angles of molecular toxicology, pharmacokinetics, endogenous metabolites change, drug transporters, cell signal transduction pathways and regulatory factors, with the different levers of gene, molecular,cellular and in vivo. Further validation from the preclinical safety evaluation of clinical trials to make the good results of basic research. Therefore, This study proposes a new point of view for the Lei-Gong-Teng derivative specific molecular mechanis咖 of organ toxicity, which provider new basis, a new means of prevention and early clinical drug safety, and open up new conversion road for the heritage of Traditional Chinese Medicine, drug discovery, toxicology research. |
| 会议录 | 2016（第二届）毒性测试替代方法与转化毒理学（国际）学术研讨会暨有害结局路径（AOP）与风险评估培训会议论文集
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| 文献子类 | Article |
| 语种 | 英语 |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/267025]  |
| 专题 | 药物安全性评价中心 |
| 作者单位 | 中国科学院上海药物研究所,药物安全性评价中心,上海 201203, 中国. |
| 推荐引用方式 GB/T 7714 | Ren J. Valuable model for clinical trail-System Toxicological Studies on Active Components in derivatives of Lei-Gong-Teng from Traditional Chinese Medicines[C]. 见:. |
入库方式： OAI收割
来源：上海药物研究所
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