摘要
目的建立一测多评(QAMS)法检测固肾定喘丸中肉桂酸、桂皮醛、大车前苷、毛蕊花糖苷、异毛蕊花糖苷、木通苯乙醇苷B、补骨脂素、异补骨脂素、新补骨脂异黄酮、补骨脂二氢黄酮的含量,并结合化学模式识别分析对固肾定喘丸进行质量评价。方法采用高效液相色谱法进行测定。以补骨脂素为内参物,建立其他9个待测成分的相对校正因子,计算其含量,并与外标法测定结果进行比较;通过对QAMS法计算结果进行聚类分析、主成分分析和偏最小二乘法-判别分析,评价15批固肾定喘丸的质量。结果上述10个待测成分分别在各自检测质量浓度范围内线性关系良好(r>0.9990);精密度、重复性、稳定性、加样回收率的RSD均小于2.00%;QAMS法测定结果与外标法测定结果差异无统计学意义(P>0.05);聚类分析和主成分分析结果显示,15批固肾定喘丸聚为3类;偏最小二乘法-判别分析结果显示,补骨脂素、毛蕊花糖苷、桂皮醛、异补骨脂素是影响固肾定喘丸产品质量的潜在标志性成分。结论所建立的QAMS法多指标成分定量控制及化学模式识别分析可用于固肾定喘丸的质量评价。
OBJECTIVE To establish quantitative analysis of multi-components by single marker(QAMS)method to simultaneously detect the contents of cinnamic acid,cinnamaldehyde,plantamajoside,verbascoside,isoacteoside,calceolarioside B,psoralen,isopsoralen,neobavaisoflavone and bavachin in Gushen dingchuan pill,and to perform quality evaluation of Gushen dingchuan pill by combining with chemical pattern recognition.METHODS High-performance liquid chromatography was adopted.Using psoralen as internal standard,the relative correction factors of the other 9 components were established,and the contents of each component were calculated and compared with those determined by external standard method.Cluster analysis,principal component analysis and partial least squares discrimination analysis were performed by the results of QAMS method,and the qualities of 15 batches of Gushen dingchuan pills were evaluated.RESULTS The above 10 components showed a good linear relationship in their respective ranges(r>0.9990).RSDs of precision,repeatability,stability and recovery tests were all lower than 2.00%.There was no significant difference between QAMS method and external standard method(P>0.05).The results of cluster analysis and principal component analysi showed that 15 batches of Gushen dingchuan pills could be clustered into 3 categories.The results of partial least squares discrimination analysis showed that psoralen,verbascoside,cinnamaldehyde and isopsoralen were the main potential markers affecting the quality of Gushen dingchuan pills.CONCLUSIONS Established QAMS method for quantitative control of multi index components and chemical pattern recognition can be used for the quality evaluation of Gushen dingchuan pills.
作者
张颖
李志平
高雨秋
王加良
侯甲福
ZHANG Ying;LI Zhiping;GAO Yuqiu;WANG Jialiang;HOU Jiafu(Dept.of Pharmacy,Hongqi Hospital Affiliated to Mudanjiang Medical University,Heilongjiang Mudanjiang 157011,China;School of Pharmacy,Mudanjiang Medical University,Heilongjiang Mudanjiang 157011,China)
出处
《中国药房》
CAS
北大核心
2022年第18期2230-2234,共5页
China Pharmacy
基金
黑龙江省省属高等学校基本科研业务费科研项目(No.2019-KYYWF-0983)。
关键词
固肾定喘丸
多指标成分
一测多评法
化学模式识别分析
Gushen dingchuan pills
multi-index component
QAMS method
chemical pattern recognition analysis
