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响应面法对六味地黄方醇沉工艺的优化研究
引用本文:闫明,韦迎春,李雪峰,孟瑾,吴云,萧伟.响应面法对六味地黄方醇沉工艺的优化研究[J].中国中药杂志,2015,40(19):3794-3799.
作者姓名:闫明  韦迎春  李雪峰  孟瑾  吴云  萧伟
作者单位:江苏康缘药业股份有限公司, 江苏 连云港 222001;中药制药过程新技术国家重点实验室, 江苏 连云港 222001,江苏康缘药业股份有限公司, 江苏 连云港 222001;中药制药过程新技术国家重点实验室, 江苏 连云港 222001,江苏康缘药业股份有限公司, 江苏 连云港 222001;中药制药过程新技术国家重点实验室, 江苏 连云港 222001,江苏康缘药业股份有限公司, 江苏 连云港 222001;中药制药过程新技术国家重点实验室, 江苏 连云港 222001,江苏康缘药业股份有限公司, 江苏 连云港 222001;中药制药过程新技术国家重点实验室, 江苏 连云港 222001,江苏康缘药业股份有限公司, 江苏 连云港 222001;中药制药过程新技术国家重点实验室, 江苏 连云港 222001
摘    要:优化六味地黄方醇沉工艺,获得最优的醇沉工艺,为醇沉过程苷类控制提供理论依据。采用P-B试验设计,以莫诺苷、马钱苷、芍药苷为指标,考察醇沉前液密度、醇沉温度、搅拌速度、加醇浓度、静置温度、静置时间、醇含量、加醇方式、离心、醇洗10个参数对醇沉工艺的影响,得出六味地黄方浸膏苷类醇沉关键工艺参数。并采用Box-Behnken 响应面法对关键工艺参数与醇沉效果的影响进行研究与探讨,得出关键工艺参数之间的交互影响以及与指标成分的相关性方程。通过对各个指标结果建立二次回归模型,并对二次回归方程求解得到六味地黄方苷类醇沉的最优工艺参数:醇沉前浸膏密度为1.13 g·mL-1,加入95%乙醇醇沉至含醇量为34%,580 r·min-1搅拌15 min,静置17 h,离心得到醇沉上清液,验证实验结果与模型预测值接近。采用响应面法优化六味地黄方苷类醇沉工艺确定工艺参数的方法合理可行。

关 键 词:六味地黄方  苷类  醇沉工艺  响应面法
收稿时间:2015/4/25 0:00:00

Optimization on alcohol precipitation techniques of Liuwei Dihuang decoction by response surface methodology
YAN Ming,WEI Ying-chun,LI Xue-feng,MENG Jin,WU Yun and XIAO Wei.Optimization on alcohol precipitation techniques of Liuwei Dihuang decoction by response surface methodology[J].China Journal of Chinese Materia Medica,2015,40(19):3794-3799.
Authors:YAN Ming  WEI Ying-chun  LI Xue-feng  MENG Jin  WU Yun and XIAO Wei
Institution:Jangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China,Jangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China,Jangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China,Jangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China,Jangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China and Jangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, China;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China
Abstract:The theoretical basis of the alcohol precipitation process control was provided, the alcohol precipitation was optimized and the relationship equation was got. The monod glycoside, loganin and paeoniflorin were used as the evaluation indexes to determine the impact factors of alcohol precipitation techniques of Liuwei Dihuang decoction by the Plackett-Burman experimental design and the levels of non-significant factors were identified. Then, Box-Behnken response surface methodology was used to research and discuss the critical process parameters influence the effect of alcohol precipitation and draw interaction between key process parameters and the correlation equation with index components. Through the establishment and solving the quadratic regression model of composite score, the optimum preparation conditions of alcohol precipitation techniques of liuwei were as follows: stirring speed was 580 r·min-1, standing time was 17 hours, alcohol concentration was 34%, the density of Liuwei Dihuang decoction was 1.13. The response surface methodology for optimized alcohol precipitation techniques of Liuwei Dihuang decoction is reasonable and feasible.
Keywords:Liuwei Dihuang decoction  glycosides  alcohol precipitation techniques  Box-Behnken response surface methodology
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