| 摘要: |
| 目的：基于质量源于设计（QbD）理念对肺复方颗粒醇提工艺进行研究与优化。方法：以固体物质提取量、重楼总皂苷提取量为关键质量属性（CQAs）,采用单因素和正交试验筛选潜在关键工艺参数（CPPs）,通过Box-Behnken设计建立模型,考察关键工艺参数与关键质量属性之间的交叉作用,并建立肺复方颗粒醇提工艺的设计空间及空间优化。结果：方差分析结果显示所建模型具有统计学意义（P＜0.05或P<0.01）,各因素与响应值之间可用所建模型进行函数化。通过设计空间优化得到肺复方颗粒最佳醇提工艺为：提取2次,提取时间为2 h/次,加75%乙醇6～6.8倍。结论：基于QbD理念研究和开发的肺复方颗粒醇提工艺稳定、可靠,为其制剂的工艺开发及质量控制提供了参考。 |
| 关键词: 质量源于设计 肺复方 Box-Behnken设计 醇提工艺 |
| DOI： |
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| Alcohol extraction process for Feifufang granules based on the quality-by-design concept |
| LI Yuehui,PENG Yanmei,WANG Zhiqi |
| (Hunan Academy of Chinese Medicine,Changsha 410006,Hunan,China;Hunan University of Chinese Medicine,Changsha 410208,Hunan,China) |
| Abstract: |
| Objective:To investigate and optimize the alcohol extraction process for Feifufang granules based on the quality-by-design (QbD) concept.Methods：With the extraction yields of solid substance and Rhizoma Paridis total saponins as critical quality attributes (CQAs),single-factor and orthogonal tests were used to screen out critical process parameters (CPPs),and a model was established based on Box-Behnken design to investigate the interaction between CPPs and CQAs and establish the design space and space optimization of the alcohol extraction process for Feifufang granules.Results：The analysis of variance showed that the model established had statistical significance (P＜0.05 or P＜0.01),and the relationship between each factor and response value could be functionalized by the model established.Design space optimization showed that the optimal alcohol extraction process for Feifufang granules was extraction twice,an extraction time of 2 hours each time,and 6-6.8 times of 75% alcohol.Conclusion：The alcohol extraction process for Feifufang granules developed based on the QbD concept is stable and reliable and provides a reference for the process development and quality control of this preparation. |
| Key words: quality-by-design Feifufang Box-Behnken design alcohol extraction process |
