星点设计-效应面法优化柴银口服液提取工艺及其稳定性研究  

Optimization of Extraction Process and Stability of Chaiyin Oral Liquid by Central Composite Design-response Surface Methodology

作　　者：刘震远 张微 郭田甜 韩培 刘思延 王爽 吴天琦 王常棋 杜昊忱 关永霞 LIU Zhen-yuan;ZHANG Wei;GUO Tian-tian;HAN Pei;LIU Si-yan;WANG Shuang;WU Tian-qi;WANG Chang-qi;DU Hao-chen;GUAN Yong-xia(Lunan Houpu Pharmaceutical Co.,Ltd.,Linyi 276000,China;State Key Laboratory of Generic Manufacture Technology of Traditional Chinese Medicine,Lunan Pharmaceutical Group Co.,Ltd.,Linyi 276000,China)

机构地区：[1]鲁南厚普制药有限公司,山东临沂276000 [2]鲁南制药集团股份有限公司中药制药共性技术国家重点实验室,山东临沂276000

出　　处：《中国现代中药》2023年第3期590-596,共7页Modern Chinese Medicine

基　　金：2020年度山东省重点研发计划项目(2020CXGC010505,2021CXGC010508);2021年度山东省新旧动能转换重大产业攻关项目(鲁动能办〔2021〕23号);兰山区2020年科技创新发展计划专项(2026)。

摘　　要：目的:优化柴银口服液提取工艺,明确其成品稳定性。方法:在单因素试验基础上将加水量、提取时间、提取次数作为考察因素,以黄芩苷转移率与澄清度值的总评归一(OD)值为评价指标,采用星点设计-效应面法优化柴银口服液提取工艺,将经优化后工艺条件生产的柴银口服液成品与原工艺成品进行加速与长期稳定性对比。结果:最佳提取工艺参数为加水量8.3倍、提取时间2.2 h、提取3次,此条件下OD值最高为0.702,此条件下生产的柴银口服液在稳定性考察中pH、澄清度、黄芩苷含量及微生物限度等指标均明显优于原工艺成品。结论:星点设计-效应面法优化柴银口服液提取工艺方法可靠、参数精确,能有效提升其价值、延长保质期。Objective:To optimize the extraction process of Chaiyin Oral Liquid and determine the stability of the finished product.Methods:Based on the single factor test,water addition times,extraction time,and extraction times were taken as the investigation factors.The OD value of the baicalin transfer rate and clarity value was used as the evaluation index.The extraction process was optimized by the central composite design-response surface methodology.Then the Chaiyin Oral Liquid produced under the optimized process conditions was compared with the finished product of the original process for accelerated and long-term stability.Results:The optimum extraction process parameters were 8.3 times of water addition,2.2 h of extraction time,and 3 times of extraction.Under this condition,the highest total evaluation OD value was 0.702.The Chaiyin Oral Liquid produced under this condition was better than the product made by the original process in pH,clarity,baicalin content,and microbial limit.Conclusion:The central composite design-response surface method is reliable for the extraction of Chaiyin Oral Liquid,with accurate and stable parameters,which has effectively improved the value of the drug and prolonged the shelf life.

关 键 词：柴银口服液 提取工艺 星点设计-效应面法 稳定性 

分 类 号：R286[医药卫生—中药学]