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鸡根标准汤剂提取工艺优化及其质量标准建立

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目的 优化鸡根标准汤剂提取工艺,并建立其质量标准.方法 在单因素试验基础上,以浸泡时间、加水量、一煎时间为影响因素,3,6'-二芥子酰基蔗糖含量、出膏率的综合评分为评价指标,响应面法优化提取工艺.测定3,6'-二芥子酰基蔗糖含量及转移率,建立HPLC特征图谱,进行聚类分析、主成分分析和正交偏最小二乘判别分析.结果 最佳条件为浸泡时间60 min,加水量(12+11)倍,煎煮时间(47+20)min,综合评分为97.98分.15批标准汤剂平均出膏率为14.182％,转移率为20.468％;其特征图谱中有6个共有峰,相似度均大于0.9(除S4、S8外).各批标准汤剂聚为2类,3种主成分累积方差贡献率达91.4％,峰2、6为质量标志物.结论 该方法精密稳定,重复性好,可用于鸡根标准汤剂的制备及质量控制.
Extraction process optimization and quality standard establishment for Jigen Standard Decoction
AIM To optimize the extraction process for Jigen Standard Decoction,and to establish its quality standard.METHODS With soaking time,water addition and first decoction time as influencing factors,comprehensive score for 3,6'-disinapoyl sucrose content and yield rate as an evaluation index,the extraction process was optimized by response surface method on the basis of single factor test.The content and transfer rate of 3,6'-dimustayl sucrose were determined,after which HPLC characteristic chromatograms were established,cluster analysis,principal component analysis and orthogonal partial least squares discriminant analysis were performed.RESULTS The optimal conditions were determined to be 60 min for soaking time,(12+11)times for water addition,and(47+20)min for decoction time,the comprehensive score was 97.98.Fifteen batches of standard decoctions demonstrated the average yield rate and transfer rate of 14.182％and 20.468％,respectively,whose characteristic chromatograms existed six common peaks with the similarities of more than 0.9(except for S4,S8).Various batches of standard decoctions were clustered into two types,three principal components displayed the acumulative variance contribution rate of 91.4％,peaks 2,6 were quality markers.CONCLUSION This precise,stable and reproducible method can be used for the preparation and quality control of Jigen Standard Decoction.

Jigen Standard Decoctionextraction processquality standardresponse surface methodHPLC characteristic chromatogramscluster analysisprincipal component analysisorthogonal partial least squares discriminant analysis

杨国春、杨亚芳、徐素娥、柯瑾、陈凌云、侯安国、金文彬

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云南中医药大学中药学院,云南昆明 650500

云南省高校外用给药系统与制剂技术研究重点实验室,云南昆明 650500

鸡根标准汤剂 提取工艺 质量标准 响应面法 HPLC特征图谱 聚类分析 主成分分析 正交偏最小二乘判别分析

国家自然科学基金项目云南省重大科技专项云南省中医药学分子生物学重点实验室项目云南省基础研究专项云南省中医联合专项

82104067202102AA3100272019DG016202001AU070133202001AZ070001-091

2024

10.3969/j.issn.1001-1528.2024.06.001

中成药
国家食品药品监督管理局,信息中心中成药信息站,上海中药行业协会

中成药

CSTPCD北大核心
影响因子：1.217
ISSN：1001-1528
年,卷(期)：2024.46(6)