摘要
目的:优化并评价经典名方散偏汤标准汤剂及颗粒剂制备工艺,为实际应用提供技术支持。方法:建立散偏汤HPLC特征图谱,对色谱信息进行主成分分析,选择指标成分进行含量测定,结合Box-Behnken响应面法综合优化散偏汤制备工艺。后依据制粒难易程度、相关性检查、成本等要求筛选合适制粒工艺,进行中试批量生产。结果:确定最优提取工艺为加10倍量水,先浸泡0.5h,加热回流提取2次,每次提取1h。制粒工艺:浓缩至密度为1.20~1.30g/mL稠浸膏,加可溶性淀粉制软材,药辅比1:1.6,摇摆制粒机过筛干燥整粒即得。颗粒剂相关检查符合《中华人民共和国药典》规定,指标成分量值传递均在70%以上。结论:特征图谱质量概貌结合有关指标性成分可作为散偏汤制备工艺的质量评控方法,得出的汤剂及颗粒剂制备工艺简单可行,为散偏汤复方制剂进一步研究与开发奠定了基础。
Objective:To optimize and evaluate the preparation process of Sanpian Decoction standard decoction and granule,and to provide technical support for practical application.Methods:The characteristic chromatogram of Sanpian Decoction was established by HPLC,the chromatographic information was analyzed by principal component analysis,the content of the selected index components was determined,and the preparation process of Sanpian Decoction was optimized by Box-Behnken-response surface method.After that,according to the requirements of granulation difficulty,correlation inspection,cost,and so on,suitable granulation process was screened for pilot test.Results:The optimal extraction process was determined:10 times of water was added,soaked for 0.5 h,and extracted for 2 times,1 h each time.Granulation process:Concentrate to 1.20~1.30 g/mL thick extract,add soluble starch to make soft material,drug to auxiliary ratio of 1:1.6,swing granulating machine sieve dry whole grain.The relevant tests of granules were consistent with the Pharmacopoeia of the People's Republic of China,and the transmission of the index components was above 70%.Conclusion:The quality profile of the characteristic map combined with the relevant index components can be used as the quality control method of Sanpian Decoction preparation process.The preparation process of decoction and granule is simple and feasible,which lays the foundation for further research and development of Sanpian Decoction compound preparation.
作者
刘佳瑶
胡恩洁
李欧
张晓燕
高小康
LIU Jiayao;HU Enjie;LI Ou;ZHANG Xiaoyan;GAO Xiaokang(School of Pharmaceutical Sciences,Hubei University of Medicine,Hubei Key Laboratory of Wudang Local Chinese Medicine Research,Shiyan 442000,China;Shiyan Renmin Hospital,Shiyan 442000,China)
出处
《中华中医药杂志》
CAS
CSCD
北大核心
2024年第7期3619-3625,共7页
China Journal of Traditional Chinese Medicine and Pharmacy
基金
湖北省科技厅中央引导地方科技发展专项(No.2019ZYYD071)
十堰市科技局一般项目(No.19K68)。
关键词
经典名方
散偏汤
Box-Behnken响应面法
制粒工艺
主成分分析
Classical prescription
Sanpian Decoction
Box-Behnken response surface method
Granulation process
Principalcomponentanalysis
