响应面法优化生脉饮澄清工艺及不同澄清剂对药品品质的影响  

Optimization of Clarifying Process of Shengmai Decoction and Effect of Different Clarifying Agents on Drug Quality by Response Surface Methodology

作　　者：刘震远 郝豪奇 江思琪 白雪 陈乃振 姜明月 郭田甜 韩培 吴天琦 王常棋 张微 高延甲 LIU Zhenyuan;HAO Haoqi;JIANG Siqi;BAI Xue;CHEN Naizhen;JIANG Mingyue;GUO Tiantian;HAN Pei;WU Tianqi;WANG Changqi;ZHANG Wei;GAO Yanjia(Lunan Houpu Pharmaceutical Co.,Ltd.,Linyi 276000,China;State Key Laboratory of Integration and Innovation of Classic Formula and Modern Chinese Medicine,Linyi 276000,China;Shandong Province Traditional Chinese Medicine Pharmaceutical Common Technology Engineering Laboratory,Linyi 276000,China;Shandong University of Traditional Chinese Medicine,Ji'nan 250355,China;Shandong Center for Food and Drug Evaluation&Inspection,Ji'nan 250014,China)

机构地区：[1]鲁南厚普制药有限公司,临沂276000 [2]经方与现代中药融合创新全国重点实验室,临沂276000 [3]山东省中药制药共性技术工程实验室,临沂276000 [4]山东中医药大学,济南250355 [5]山东省食品药品审评查验中心,济南250014

出　　处：《世界中医药》2025年第3期386-392,共7页World Chinese Medicine

基　　金：国家重点研发计划“中医药现代化”重点专项(2022YFC3502105);山东省重点研发计划项目(2021CXGC010508);山东省新旧动能转换重大产业攻关项目(鲁动能办〔2021〕23号)。

摘　　要：目的:优化生脉饮澄清工艺条件,提升药品品质。方法:在单因素试验基础上,采取Box-Behnken响应面分析法,将壳聚糖溶液添加量、澄清温度、搅拌速度、作用时间作为考察因素,以澄清度值与五味子醇甲保留率的总评归一(OD)值为评价指标,优选出最佳澄清工艺条件。取最佳澄清工艺条件下生产的3批药品进行验证试验,并与其他3种澄清方式(ZTC 1+1Ⅲ型澄清剂、101-澄清剂、明胶澄清剂)进行对比,明确其优化效果。结果:生脉饮最佳澄清工艺参数条件为壳聚糖溶液添加量4%、澄清温度59℃、搅拌速度240 r/min、作用时间25 min,OD值平均达0.748。所生产的生脉饮药液清澈、明亮,透光性强,药物品质明显优于其他3种澄清方式。结论:壳聚糖絮凝法优化生脉饮口服液澄清工艺方法可靠,参数精确、稳定。壳聚糖絮凝法优化生脉饮澄清工艺条件可提升药品品质。Objective:To optimize the clarifying process of Shengmai Decoction to enhance pharmaceutical quality.Methods:Based on single-factor experiments,the Box-Behnken response surface methodology was employed.With chitosan solution addition,clarifying temperature,stirring speed,and reaction time as influencing factors,and overall desirability(OD)value,incorporating both clarity and the retention rate of schisandrin,as the evaluation index,the optimal clarifying conditions were determined.Three batches of Shengmai Decoction produced under the optimized conditions were subjected to validation tests and compared with three other clarifying methods(ZTC 1+1Ⅲ clarifier,101 clarifier,and gelatin clarifier)to assess the improvement.Results:The optimal clarifying parameters for Shengmai Decoction were determined as follows:chitosan solution addition at 4%,clarifying temperature at 59℃,stirring speed at 240 r/min,and reaction time of 25 min,achieving an average OD value of 0.748.The resulting Shengmai Decoction solution was clear,bright,and highly transparent,with significantly improved pharmaceutical quality compared to the other three clarifying methods.Conclusion:The chitosan flocculation method is a reliable and stable optimization approach for clarifying Shengmai Decoction oral solution,with precise and reproducible parameters.Optimizing the clarifying process using this method enhances the pharmaceutical quality of Shengmai Decoction.

关 键 词：生脉饮 澄清工艺 壳聚糖絮凝法 ZTC 1+1Ⅲ型澄清剂 101-澄清剂 明胶澄清剂 

分 类 号：R283.6[医药卫生—中药学] R943.1[医药卫生—中医学] TS262.7[轻工技术与工程—发酵工程]