| This study took ethanol recycling reflux extraction and ethanol extraction-water precipitation process of Panax notoginseng as the investigated subject, the main con-tents were summarized as follows:1. An analytical method for determination of the content of five major saponins, namely notoginsenoside R1, ginsenoside Rg1, Re, Rb1, Rd in the extracts of panax notoginseng was established based on the idea of design space. The mathematical relationship between analytical conditions and critical quality attributes (CQAs) was obtained by using design of experiments and regression model. The design space and operation space were calculated using Monte Carlo method. The opti-mised analytical condition was verified and can be used for determination of the content of five major saponins in Panax notoginseng extracts.2. An ethanol recycling reflux extraction process of Panax notoginseng was studied. Saponin yield, purity of total saponin and pigment yield were confirmed as the process critical quality attributes (CQAs). Ethanol concentration, extraction time and the ratio of recycling ethanol flow rate to initial solvent volume in the extrac- tion tank (RES) were identified as the critical process parameters (CPPs) using risk assessment. The mathematical relationship between CQAs and CPPs was ob-tained by using design of experiments and statistical modeling. Monte Carlo method was used for calculating the design space and operation space. Design space was verified and the experimental results showed that the design space was reliable.3. The process of ethanol extraction and water precipitation was taken as investigat-ed subject. Several abnormal process parameters were manually introduced into the sample preparation process to cause the quality abnormality of the product. Statistical control model was established using multivariate data analysis based on data acquired by HPLC-MS and UV. |
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