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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: To apply the method of knowledge organization to the identification of potential key process parameters of traditional Chinese medicine under the guidance of the concept of “quality by design” (QbD). Methods: Taking the relevant literature of ethanol extraction process of Salvia miltiorrhiza as the research object, the rank and ratio method was adopted to realize the identification of the key process parameters of Salvia miltiorrhiza by knowledge organization through knowledge extraction, knowledge reorganization and result analysis. Results: The influence of ethanol extraction process on the key process parameters of Salvia miltiorrhiza Bunge was successfully identified by using knowledge organization method and rank sum ratio method. The effects of ethanol volume fraction and ethanol consumption were the most important, with rank sum ratios of 0.319 3 and 0.252 1, respectively The number of extraction, extraction time and extraction temperature, rank sum ratio were 0.180 7,0.205 9,0.067 23. Conclusion: The knowledge organization method guided by Qb D concept can effectively identify potential key process parameters in the process of TCM production, and provide guidance for the quality control of TCM production process.