Optimization of lime milk precipitation process of Lonicera Japonica aqueous extract based on quality by design concept.
10.19540/j.cnki.cjcmm.20170223.013
- Author:
Jin-Jing SHEN
1
;
Xing-Chu GONG
1
;
Jian-Yang PAN
1
;
Hai-Bin QU
1
Author Information
1. Pharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China.
- Publication Type:Journal Article
- Keywords:
Lonicera Japonica;
design space;
lime milk precipitation process;
lime milk-sulfuric acid-ethanol method;
quality by design
- From:
China Journal of Chinese Materia Medica
2017;42(6):1074-1082
- CountryChina
- Language:Chinese
-
Abstract:
Design space approach was applied in this study to optimize the lime milk precipitation process of Lonicera Japonica (Jinyinhua) aqueous extract. The evaluation indices for this process were total organic acid purity and amounts of 6 organic acids obtained from per unit mass of medicinal materials. Four critical process parameters (CPPs) including drop speed of lime milk, pH value after adding lime milk, settling time and settling temperature were identified by using the weighted standardized partial regression coefficient method. Quantitative models between process evaluation indices and CPPs were established by a stepwise regression analysis. A design space was calculated by a Monte-Carlo simulation method, and then verified. The verification test results showed that the operation within the design space can guarantee the stability of the lime milk precipitation process. The recommended normal operation space is as follows： drop speed of lime milk of 1.00-1.25 mL•min⁻¹, pH value of 11.5-11.7, settling time of 1.0-1.2 h, and settling temperature of 10-20 ℃..
