| 基于多维结构过程动态的中药制剂产品肝毒性的影响因素 |
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| 引用本文： | 刘莹,汪刚,仲青香,吴豪,宋捷,封亮,贾晓斌.基于多维结构过程动态的中药制剂产品肝毒性的影响因素[J].中国中药杂志,2017,42(16):3031-3035. |
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| 作者姓名： | 刘莹 汪刚 仲青香 吴豪 宋捷 封亮 贾晓斌 |
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| 作者单位： | 安徽中医药大学 药学院, 安徽 合肥 230012;江苏省中医药研究院 国家中医药管理局中药释药系统重点研究室, 江苏 南京 210028,安徽中医药大学 药学院, 安徽 合肥 230012;江苏省中医药研究院 国家中医药管理局中药释药系统重点研究室, 江苏 南京 210028,江苏省中医药研究院 国家中医药管理局中药释药系统重点研究室, 江苏 南京 210028;南京中医药大学 第三临床医学院, 江苏 南京 210028,安徽中医药大学 药学院, 安徽 合肥 230012;江苏省中医药研究院 国家中医药管理局中药释药系统重点研究室, 江苏 南京 210028,江苏省中医药研究院 国家中医药管理局中药释药系统重点研究室, 江苏 南京 210028;南京中医药大学 第三临床医学院, 江苏 南京 210028,江苏省中医药研究院 国家中医药管理局中药释药系统重点研究室, 江苏 南京 210028,江苏省中医药研究院 国家中医药管理局中药释药系统重点研究室, 江苏 南京 210028;南京中医药大学 第三临床医学院, 江苏 南京 210028 |
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| 基金项目： | 国家自然科学基金项目（81573620）；国家中医药管理局2015年公益性行业科研专项（201507004-10）；江苏省第十三批“六大人才高峰”创新人才团队项目（SWYY-CXTD-004）；江苏省青年医学人才项目（QNRC2016634）；江苏省医学创新团队（CXTDB2017003） |
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| 摘 要： | 中药制剂产品是以中药材或饮片为原料,根据药物的不同性质,采用一定的制剂工艺和加工过程而制成的药物成品。在其作用于机体产生的不良反应中,肝脏毒性不容忽视。多维结构过程动态的质控体系作为中药制剂质控的新阶段,强调对其有效性和安全性的研究,着重从中药材的前处理、制剂工艺、剂型和给药途径等方面控制中药制剂产品的质量,减少肝毒性的产生。因此该文将从这些因素出发,探析制剂产品产生肝毒性的原因,为发展优质低毒的现代化中药制剂产品提供参考。
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| 关 键 词： | 中药制剂 肝毒性 制剂工艺 多维结构过程动态质控体系 |
| 收稿时间： | 2017/5/30 0:00:00 |
Influence factors of hepatotoxicity of traditional Chinese medicine preparation products based on multidimensional structure dynamic process |
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| LIU Ying,WANG Gang,ZHONG Qing-xiang,WU Hao,SONG Jie,FENG Liang and JIA Xiao-bin.Influence factors of hepatotoxicity of traditional Chinese medicine preparation products based on multidimensional structure dynamic process[J].China Journal of Chinese Materia Medica,2017,42(16):3031-3035. |
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| Authors: | LIU Ying WANG Gang ZHONG Qing-xiang WU Hao SONG Jie FENG Liang and JIA Xiao-bin |
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| Institution: | School of Pharmacy, Anhui University of Chinese Medicine, Hefei 230012, China;Key Laboratory of New Drug Delivery Systems of Chinese Materia Medica, Jiangsu Provincial Academy of Chinese Medicine, Nanjing 210028, China,School of Pharmacy, Anhui University of Chinese Medicine, Hefei 230012, China;Key Laboratory of New Drug Delivery Systems of Chinese Materia Medica, Jiangsu Provincial Academy of Chinese Medicine, Nanjing 210028, China,Key Laboratory of New Drug Delivery Systems of Chinese Materia Medica, Jiangsu Provincial Academy of Chinese Medicine, Nanjing 210028, China;College of Third Clinical Medicine, Nanjing University of Chinese Medicine, Nanjng 210028, China,School of Pharmacy, Anhui University of Chinese Medicine, Hefei 230012, China;Key Laboratory of New Drug Delivery Systems of Chinese Materia Medica, Jiangsu Provincial Academy of Chinese Medicine, Nanjing 210028, China,Key Laboratory of New Drug Delivery Systems of Chinese Materia Medica, Jiangsu Provincial Academy of Chinese Medicine, Nanjing 210028, China;College of Third Clinical Medicine, Nanjing University of Chinese Medicine, Nanjng 210028, China,Key Laboratory of New Drug Delivery Systems of Chinese Materia Medica, Jiangsu Provincial Academy of Chinese Medicine, Nanjing 210028, China and Key Laboratory of New Drug Delivery Systems of Chinese Materia Medica, Jiangsu Provincial Academy of Chinese Medicine, Nanjing 210028, China;College of Third Clinical Medicine, Nanjing University of Chinese Medicine, Nanjng 210028, China |
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| Abstract: | Traditional Chinese medicine (TCM) products are the finished products by adopting certain preparation processes according to the profile of the herbs, with Chinese herbs or decoction pieces as the raw materials.Among their adverse reactions to the organs, hepatotoxicity can not be ignored. As a new stage of quality control in TCM, dynamic quality control system of the multidemensional structure process emphasized on the research of the effectiveness and safety, focused on the pretreatment, preparation process, dosage forms and drug delivery methods to control the quality of TCM preparation products and reduce the generation of hepatotoxicity.In this paper, we will start from these factors to discuss the causes of hepatotoxicity underlying drug products and hope to provide the reference for developing low toxicity and high quality modern Chinese medicine products. |
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| Keywords: | traditional Chinese medicine preparation products hepatotoxicity preparation process dynamic quality control system of multidimensional structure process |
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