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(1)
[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。
[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
Influence factors of hepatotoxicity of traditional Chinese medicine
preparation products based on multidimensional
, 百拇医药
structure dynamic process
LIU Ying1,2, WANG Gang1,2, ZHONG Qingxiang2,3, WU Hao1,2, SONG Jie2,3, FENG Liang2*, JIA Xiaobin2,3*
(1School of Pharmacy, Anhui University of Chinese Medicine, Hefei 230012, China;
2 Key Laboratory of New Drug Delivery Systems of Chinese Materia Medica, Jiangsu Provincial
Academy of Chinese Medicine, Nanjing 210028, China;
, http://www.100md.com
3College of Third Clinical Medicine, Nanjing University of Chinese Medicine, Nanjng 210028, China)
[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 materialsAmong 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 hepatotoxicityIn 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
, http://www.100md.com
[Key words]traditional Chinese medicine preparation products; hepatotoxicity; preparation process; dynamic quality control system of multidimensional structure process
多維结构过程动态质控体系是本课题组基于“组分结构理论”提出的对中药(制剂)原材料、精制纯化、制备工艺、中间体以及成品等多个环节实行过程动态的质量控制保证体系[1],具有多维、动态的特色优势,是对中药及其制剂质量控制的一个新发展。肝脏作为药物代谢的主要器官,中药制剂产品对其产生潜在肝毒性的几率就会大大增加。倘若从中药材本身到前处理、制剂工艺、剂型和给药途径、储存运输等环节出发发掘影响中药制剂肝毒性的因素,并运用一套适合中药制剂特点的质控体系控制制剂的质量,将有利于降低发生肝毒性的风险,保证制剂产品的安全性和有效性。
1“多维结构过程动态质控体系”的内涵
, 百拇医药
中药本身是一个复杂的体系,要将其制成成品应用于临床,必须保证安全性和有效性。鉴于中药(制剂)系统性和整体性的特点,作者提出“3个层次多维结构”理论[2]:即单体成分作为组成物质基础的最基本单元,具有稳定的三维结构;同一化学类别成分构成组分,组分中各单体成分之间存在结构关系;由多组分构成的整体作为中药复方的物质基础,其各组分间存在结构特征。从此,对中药及其制剂的研究实现了在“多维结构”水平上由单体向多成分构成的组分内及多组分“全面”“多层次”整体组成结构的跨越,以稳定结构比范围的“可控范围窗”作为中药(制剂)质量控制的新标准[3]。该质控体系包括4个核心技术:与有效性有关的物质基础特征、与安全性有关的物质基础特征、剂型是保证有效性与安全性的重要因素、实现制剂产品的过程多层次动态质量控制。强调对中药制剂产品生产过程中动态的质量控制,即从原料到终产品,实施全方位的质量控制以获得质量稳定均一的制剂成品,为临床用药提供保障,促进中药及其制剂的发展,见图1。, http://www.100md.com(刘莹汪刚仲青香 吴豪 宋捷封亮贾晓斌)
[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
Influence factors of hepatotoxicity of traditional Chinese medicine
preparation products based on multidimensional
, 百拇医药
structure dynamic process
LIU Ying1,2, WANG Gang1,2, ZHONG Qingxiang2,3, WU Hao1,2, SONG Jie2,3, FENG Liang2*, JIA Xiaobin2,3*
(1School of Pharmacy, Anhui University of Chinese Medicine, Hefei 230012, China;
2 Key Laboratory of New Drug Delivery Systems of Chinese Materia Medica, Jiangsu Provincial
Academy of Chinese Medicine, Nanjing 210028, China;
, http://www.100md.com
3College of Third Clinical Medicine, Nanjing University of Chinese Medicine, Nanjng 210028, China)
[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 materialsAmong 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 hepatotoxicityIn 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
, http://www.100md.com
[Key words]traditional Chinese medicine preparation products; hepatotoxicity; preparation process; dynamic quality control system of multidimensional structure process
多維结构过程动态质控体系是本课题组基于“组分结构理论”提出的对中药(制剂)原材料、精制纯化、制备工艺、中间体以及成品等多个环节实行过程动态的质量控制保证体系[1],具有多维、动态的特色优势,是对中药及其制剂质量控制的一个新发展。肝脏作为药物代谢的主要器官,中药制剂产品对其产生潜在肝毒性的几率就会大大增加。倘若从中药材本身到前处理、制剂工艺、剂型和给药途径、储存运输等环节出发发掘影响中药制剂肝毒性的因素,并运用一套适合中药制剂特点的质控体系控制制剂的质量,将有利于降低发生肝毒性的风险,保证制剂产品的安全性和有效性。
1“多维结构过程动态质控体系”的内涵
, 百拇医药
中药本身是一个复杂的体系,要将其制成成品应用于临床,必须保证安全性和有效性。鉴于中药(制剂)系统性和整体性的特点,作者提出“3个层次多维结构”理论[2]:即单体成分作为组成物质基础的最基本单元,具有稳定的三维结构;同一化学类别成分构成组分,组分中各单体成分之间存在结构关系;由多组分构成的整体作为中药复方的物质基础,其各组分间存在结构特征。从此,对中药及其制剂的研究实现了在“多维结构”水平上由单体向多成分构成的组分内及多组分“全面”“多层次”整体组成结构的跨越,以稳定结构比范围的“可控范围窗”作为中药(制剂)质量控制的新标准[3]。该质控体系包括4个核心技术:与有效性有关的物质基础特征、与安全性有关的物质基础特征、剂型是保证有效性与安全性的重要因素、实现制剂产品的过程多层次动态质量控制。强调对中药制剂产品生产过程中动态的质量控制,即从原料到终产品,实施全方位的质量控制以获得质量稳定均一的制剂成品,为临床用药提供保障,促进中药及其制剂的发展,见图1。, http://www.100md.com(刘莹汪刚仲青香 吴豪 宋捷封亮贾晓斌)