[Design space approach to optimize first ethanol precipitation process of Dangshen].
Design space approach is applied in this study to enhance the robustness of first ethanol precipitation process of Codonopsis Radix (Dangshen) by optimizing parameters. Total flavonoid recovery, dry matter removal, and pigment removal were defined as the process critical quality attributes (CQAs). Plackett-Burman designed experiments were carried out to find the critical process parameters (CPPs). Dry matter content of concentrated extract (DMCE), mass ratio of ethanol to concentrated extract (E/C ratio) and concentration of ethanol (CEA) were identified as the CPPs. Box-Behnken designed experiments were performed to establish the quantitative models between CPPs and CQAs. Probability based design space was obtained and verified using Monte-Carlo simulation method. According to the verification results, the robustness of first ethanol precipitation process of Dangshen can be guaranteed by operating within the design space parameters. Recommended normal operation space are as follows: dry matter content of concentrated extract of 45.0% - 48.0%, E/C ratio of 2.48-2.80 g x g(-1), and the concentration of ethanol of 92.0% - 92.7%.
Zhi-lin
ZL
Xu
Wen-hua
WH
Huang
Xing-chu
XC
Gong
Tian-tian
TT
Ye
Hai-bin
HB
Qu
Yan-gang
YG
Song
Dong-lai
DL
Hu
Guo-xiang
GX
Wang
D011232:Chemical Precipitation; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D029745:Codonopsis / Q000737:chemistry*; D004365:Drugs, Chinese Herbal / Q000737:chemistry* / Q000302:isolation & purification
D004365:Drugs, Chinese Herbal