星点设计-效应面法优化复方茵陈合剂的醇沉工艺  

Optimization on alcohol precipitation process of compound Yinchen mixture by central composite design-response surface method

作　　者：刘晓玲[1] 蔡小辉[1] 倪晓霞[1] 王庆芬[1] 陈锦珊[1] LIU Xiaoling;CAI Xiaohui;NI Xiaoxia;WANG Qingfen;CHEN Jinshan(The 175th Hospital of PEA,Zhangzhou 363000,China)

机构地区：[1]解放军175医院/厦门大学附属东南医院,福建漳州363000

出　　处：《药学实践杂志》2018年第4期329-333,354,共6页Journal of Pharmaceutical Practice

基　　金：福建中医药大学临床专项校管课题(XB2016067)

摘　　要：目的采用星点设计-效应面法优化复方茵陈合剂的醇沉工艺。方法以栀子苷含量和固形物去除率的总评归一值为指标,通过单因素实验考察药液相对密度、醇沉浓度、醇沉时间和搅拌速度对醇沉工艺的影响,结合医院制剂生产特点,通过趋势分析确定影响醇沉工艺的关键因素,最后采用星点设计-效应面法对关键因素进行进一步的研究与探讨。结果当药液相对密度为1.07,醇沉浓度为84%、醇沉时间为8h,搅拌速度为1762r/min时醇沉工艺达到最优。结论采用星点设计-效应面法优化了复方茵陈合剂的醇沉工艺,有助于进一步提升复方茵陈合剂工艺的稳定性。Objective To optimize the alcohol precipitation process of compound Yinchen mixture by central composite design-response surface method.Methods With the transfer rates of geniposide and solid removal rate as comprehensive evaluation index,the effects of relative density,alcohol concentration,stirring speed and standing time were investigated by the single factor experiment on the alcohol precipitation process.By analysis of variance,the key factors that could influence the alcohol precipitation process were determined.Then the range of parameters of key factors was further studied and explored by central composite design-response surface method.Results The optimum preparation conditions were as follows：the relative density was 1.07,alcohol concentration was 84%,standing time was 8 h,stirring speed was 1762 r/min.Conclusion The alcohol precipitation process of compound Yinchen mixture could be optimized by the response surface method,which could help to enhance the stability of the process.

关 键 词：复方茵陈合剂 星点设计-效应面法 醇沉工艺 总评归一值 

分 类 号：R944.6[医药卫生—药剂学]