质量源于设计:基于知识组织的中药生产潜在关键工艺参数的辨识  

Quality by Design:Identification of Potential Critical Process Parameters of Chinese Medicine Production Based on Knowledge Organization Methods

作　　者：崔雅华 王茜[1] 徐冰[1] 张志强[1,2] 杜新刚[1,2] 史新元[1] 

机构地区：[1]北京中医药大学中药学院中药生产过程控制与质量评价北京市重点实验室,北京100029 [2]北京康仁堂药业有限公司,北京101301

出　　处：《中国实验方剂学杂志》2016年第15期1-8,共8页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家自然科学基金项目(81403112);中药生产过程控制与质量评价北京市重点实验室2015年度科技创新基地培育与发展专项(Z151100001615065);北京中医药大学大学生科研项目(201410026028)

摘　　要：目的:在"质量源于设计"(quality by design,Qb D)理念的指导下,将知识组织方法应用于中药生产潜在关键工艺参数辨识。方法:以丹参乙醇提取工艺相关文献为研究对象,运用秩和比法,通过知识抽取、知识重组和结果分析实现知识组织对丹参醇提潜在关键工艺参数的辨识。结果:运用知识组织方法和秩和比法成功辨识出丹参醇提工艺关键工艺参数的影响程度,其中乙醇体积分数和乙醇用量的影响最为重要,秩和比分别为0.319 3和0.252 1;其次为提取次数、提取时间和提取温度,秩和比分别为0.180 7,0.205 9,0.067 23。结论:Qb D理念指导下的知识组织方法可以有效辨识中药生产过程中潜在关键工艺参数,为中药生产过程的质量控制提供指导。Objective： In order to improve the quality of Chinese medicine in the production,knowledge organization method was applied to the identification of critical process parameters（ CPPs） of Chinese medicine under the guidance of quality by design（ Qb D）. Method： Taking literatures related to ethanol extraction process of Salviae Miltiorrhizae Radix et Rhizoma as research object,rank-sum ratio（ RSR） method was used to achieve CPPs recognition in ethanol extraction process of Salviae Miltiorrhizae Radix et Rhizoma, containing knowledge extracting, knowledge restructuring and result analyzing. Result： By using knowledge organization method and RSR method,the importance of CPPs in the research object was recognized successfully. Ethanol concentration and ethanol consumption were in the first level, their RSR values were 0. 319 3 and 0. 252 1,respectively. Followed by number of extraction, extraction time and extraction temperature, their RSR values were 0. 180 7, 0. 205 9, 0. 067 23, respectively. Conclusion： Within the Qb D framework, knowledge organization method can identify CPPs effectively and provide guidance for quality control in production process of Chinese medicine.

关 键 词：质量源于设计 知识组织 中药 提取过程 关键工艺参数 秩和比法 

分 类 号：R283.6[医药卫生—中药学] R927.11[医药卫生—中医学]