摘要
优化林下山参滴丸的制备工艺。通过单因素试验设计确定影响滴丸制备工艺的关键因素。以滴丸外观、滴丸质量变异系数、溶散时限3项指标的OD值为因变量,采用Box-Behnken Design响应面法对关键因素(药物与基质的比例、滴速、药液温度和管口温度)进行研究,运用Design Expert8.0.5软件对试验数据进行分析,建立OD值与各自变量的多元二次回归方程的数学模型,优化工艺参数;HPLC-UV法同时测定滴丸中人参皂苷Rg1、Re、Rb1的含量。最佳工艺参数:药物与基质PEG4000、PEG6000的比例:1∶1∶4,滴速:28d/min,药液温度:87℃,管口温度:43℃,滴距:4cm,冷凝液温度:10℃;制得滴丸中人参皂苷Rg1、Re、Rb1含量分别为2.614mg/g、0.419mg/g、5.183mg/g。Box-Behnken Design响应面法较好地优化了林下山参滴丸的制备工艺;所得工艺稳定可靠,含量测定方法简单、准确、重复性好,可用于保健食品林下山参滴丸的质量控制。
To determine the optimum preparation process of Linxiashanshen Pills.The single factor experiment was applied to confirm the key factors which affect the quality of the dropping pills.According to the OD value of exterior quality,weight variation,and resolving time of pills,Box-Behnken Design experiment design was adopted to investigate the effects of the four main factors including the ratio of drug and matrix,dropping rate,temperature of drug fluid and condensate tube.Experimental data was analyzed using Design Expert 8.0.5software,multivariate quadratic regression equation mathematical model between composite score and independent variables was established to determine the optimum technical parameters.Quantitative assay was completed by a HPLC-UV method to determine the content of ginsenoside Rg1,Re,Rb1 in the pills simultaneously.The optimal preparation conditions for the pills were as follows：the ratio of drug and matrix was 1∶1∶4,dropping rate was 28 drop/min,the temperature of drug fluids was 87℃,the temperature of condensate tube outlet was 43℃,distance from emitter was 4cm,dimethylsilicone was selected as refrigerant with the temperature of 10℃.The content of ginsenoside Rg1,Re,Rb1 in the dropping pills were 2.614mg/g,0.419mg/g,5.183mg/g respectively.Box-Behnken Design-response surface methodology is suitable for optimizing preparation process of Linxiashanshen Pills.The preparation process of dropping pills is stable and reliable and the quantitative assay is simple,accurate and stable,which can be used to control the quality of the dropping pills.
作者
祁增
郑炳真
朱海林
王振洲
王翠竹
张楠淇
李平亚
刘金平
QI Zeng ZHENG Bing-zhen ZHU Hai-lin WANG Zhen-zhou WANG Cui-zhu ZHANG Nan-qi LI Ping-ya LIU Jin-ping(School of Pharmaceutical Sciences, Jilin University, Changchun 130021, China)
出处
《特产研究》
2017年第1期1-8,共8页
Special Wild Economic Animal and Plant Research
基金
吉林省双十项目(2012ZDGG010)
