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引用本文:杨耿,吕媛媛,孙晓译,夏正燕,王中昌,傅迎,黄红霞.Box-Behnken响应曲面法优化养胃颗粒提取工艺[J].中国现代应用药学,2021,38(16):1964-1969.
YANG Geng,LYU Yuanyuan,SUN Xiaoyi,XIA Zhengyan,WANG Zhongchang,FU Ying,HUANG Hongxia.Optimization of Extract Process of Yangwei Granules by Box-Behnken Response Surface Methodology[J].Chin J Mod Appl Pharm(中国现代应用药学),2021,38(16):1964-1969.
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Box-Behnken响应曲面法优化养胃颗粒提取工艺
杨耿1, 吕媛媛1, 孙晓译1, 夏正燕1, 王中昌2, 傅迎2, 黄红霞1
1.浙大城市学院医学院, 杭州 310015;2.正大青春宝药业有限公司, 杭州 310013
摘要:
目的 研究养胃颗粒提取工艺参数与质控指标的关系,确定最佳工艺参数提高提取效率。方法 采用Box-Behnken实验设计方法对养胃颗粒提取工艺中加水量、加水温度和煎煮温度3个参数与质控指标芍药苷含量的相关性进行研究,即考察加水量、加水温度和煎煮温度对芍药苷提取率的影响,建立工艺参数与质控指标之间的回归模型,确定最佳工艺参数,并加以验证。结果 加水温度、加水量和煎煮温度3个工艺参数对养胃颗粒中芍药苷的提取率均有影响,其中加水量和煎煮温度对芍药苷提取率的影响显著。经过优化,确定最佳工艺参数:加水温度37.8℃,加水量为药材总质量的4倍,煎煮温度94.7℃。在最佳工艺参数下进行提取,理论芍药苷质量含量可达到0.192 4 g·g-1。采用优化条件平行操作3次,得到的平均芍药苷含量为0.189 2 g·g-1,接近预测值。该数值相对于未优化前(按制药厂实际生产工艺条件实验值0.137 4 g·g-1)提高了37.7%。结论 研究建立的量化模型有利于工艺参数的精确控制,提高了提取效率,有利于养胃颗粒质量的提升。
关键词:  养胃颗粒  工艺优化  Box-Behnken实验设计  质控指标
DOI:10.13748/j.cnki.issn1007-7693.2021.16.007
分类号:R284.2
基金项目:浙江省中医药科技计划项目(2015ZQ022);浙江省公益事业技术研究项目(LGF21H300001);杭州市科技计划项目(20180533B09,20191203B48)
Optimization of Extract Process of Yangwei Granules by Box-Behnken Response Surface Methodology
YANG Geng1, LYU Yuanyuan1, SUN Xiaoyi1, XIA Zhengyan1, WANG Zhongchang2, FU Ying2, HUANG Hongxia1
1.School of Medicine, Zhejiang University City College, Hangzhou 310015, China;2.Chiatai Qingchunbao Pharmaceutical Co. Ltd., Hangzhou 310013, China
Abstract:
OBJECTIVE To study the relationship between the extraction parameters and quality control indexes of Yangwei granules, to determine the optimal process parameters to improve the extraction efficiency. METHODS The Box-Behnken experimental design method was used to study the correlation between the three parameters of water addition, water volume temperature and decoction temperature in the extraction process of Yangwei granules and the content of paeoniflorin, the quality control index, that is, the investigation of water volume, water addition temperature and decoction. The optimal process parameters were determined by the multiple regression model, and were further confirmed. RESULTS The study revealed that the extraction rate of paeoniflorin in Yangwei granules was directly influenced by water temperature, water volume and decoction temperature. Among these three process parameters, the water volume and decoction temperature have significant effects. Optimal process parameters for the extraction were water temperature of 37.8℃, water volume of four times the weight of medicinal material, and decoction temperature of 94.7℃. An average content of paeoniflorin from three independent experiments under optimized operations was 0.189 2 g·g-1, which was close to the theoretical value 0.192 4 g·g-1. It was 37.7% higher than that of non-optimized conditions(0.137 4 g·g-1). CONCLUSION The quantitative model established in the research is conducive to the precise control of process parameters and to increase the extraction efficiency, resulting in the improvement of the quality of Yangwei granules.
Key words:  Yangwei granules  process optimization  Box-Behnken experimental design  quality indicator
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