星点设计-多指标评价优化六味地黄丸制备工艺
投稿时间:2017-12-14     点此下载全文
引用本文:屈云萍,李菲,刘育强,杨斯斯,黄宁,姜国志.星点设计-多指标评价优化六味地黄丸制备工艺[J].中国现代中药,2018,20(6):748-754
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作者中文名作者英文名单位中文名单位英文名E-Mail
屈云萍 QU Yun-ping 神威药业集团有限公司,河北石家庄051430 Shineway Pharmaceutical Group Ltd.,Shijiazhuang 051430,China 屈云萍,高级工程师,研究方向:口服制剂品种工艺与质量标准研究;Tel:(0311)88030066-6503,E-mail:qyp218@163.com 
李菲 LI Fei 神威药业集团有限公司,河北石家庄051430 Shineway Pharmaceutical Group Ltd.,Shijiazhuang 051430,China  
刘育强 LIU Yu-qiang 神威药业集团有限公司,河北石家庄051430 Shineway Pharmaceutical Group Ltd.,Shijiazhuang 051430,China  
杨斯斯 YANG Si-si 神威药业集团有限公司,河北石家庄051430 Shineway Pharmaceutical Group Ltd.,Shijiazhuang 051430,China  
黄宁 HUANG Ning 神威药业集团有限公司,河北石家庄051430 Shineway Pharmaceutical Group Ltd.,Shijiazhuang 051430,China  
姜国志 JIANG Guo-zhi 中药注射剂新药技术开发国家地方联合工程实验室,河北石家庄051430 Nation and Local Engineering Laboratory for the New TCM Injection Technology Development,Shijiazhuang 051430,China  
基金项目:国家重大新药创制专项基金资助项目(2014ZX09301306-011);河北省科技计划基金资助项目(14272504D)
中文摘要:目的:采用单因素考察及星点设计-多指标评价优化六味地黄丸制备工艺。方法:采用四因素三水平星点设计,以浸膏相对密度、润湿剂用量、干燥温度、干燥时间为考察因素,以丸芯的水分、丹皮酚含量、溶散时限、外观质量分数为评价指标,建立二项式拟合方程,根据最佳模型绘制效应面和等高线图,选择最佳处方并进行验证试验。结果:考察因素和评价指标及总评“归一值”之间存在可信关系,二项式拟合方程相关系数r=0.993 8,经过优化后的最佳工艺参数为:浸膏相对密度1.40(30 ℃)、润湿剂(纯化水∶乙醇=1∶2)用量(40万丸用量)6.58 L、干燥温度65 ℃、干燥时间16 h。结论:星点设计-效应面法多指标评价简单可靠,所建立的数学模型具有良好的预测性和可靠性,优化后的制备工艺验证值与预测值偏差较小。
中文关键词:六味地黄丸  星点设计  多指标评价  优化制备工艺
 
Optimization of Preparation Technique of LiuWeiDiHuang Pills by Star Point Design-Multiple Indexes Evaluation
Abstract:Objective:Using Single factor examination and star point design-Multiple indexes evaluation to optimize the preparation technique of LiuWeiDiHuang pills.Methods:Using four factors -three levels star point design,taking the relative density of paste,quantity of adhesives,drying temperature and drying duration as exploring factors,using water content in the pill core,content of paeonolum,dissolution time of the pill and appearance mass fraction as evaluation index,Binomial fitting equation was established based on the best model to draw the effect surface and contour map to choose the best formula and conduct the validation test.Results:The trusted relationship could be established between examination factors and evaluation index as well as normalized value.The relative coefficient for Binomial fitting equation was r=0.993 8,the best technical parameters could be chosen after optimization,i.e.the relative density of paste was 1.40 at 30 ℃,quantity of adhesives (purified water∶ethanol=1∶2) for 400,000 pills was 6.58 L,the drying temperature is 65 ℃ and the drying duration was 16 h.Conclusion:Star point design-effect surface and multi indexes evaluation method is simple and reliable.The established mathematical model has good predictive and reliable properties.The deviation between optimized preparation technique validation parameters and predictive values is small.
keywords:LiuWeiDiHuang pills  Star Point design  multiple indexes evaluation  preparation technique optimization
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