CUI Ya-hua, WANG Xi, XU Bing, et al. Quality by Design: Identification of Potential Critical Process Parameters of Chinese Medicine Production Based on Knowledge Organization Methods[J]. Chinese journal of experimental traditional medical formulae, 2016, 22(15): 1-8.
CUI Ya-hua, WANG Xi, XU Bing, et al. Quality by Design: Identification of Potential Critical Process Parameters of Chinese Medicine Production Based on Knowledge Organization Methods[J]. Chinese journal of experimental traditional medical formulae, 2016, 22(15): 1-8. DOI: 10.13422/j.cnki.syfjx.2016150001.
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 (QbD). 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 QbD framework
knowledge organization method can identify CPPs effectively and provide guidance for quality control in production process of Chinese medicine.