Page 60 - 《中国药房》2022年18期

固肾定喘丸多指标成分一测多评法的建立及质量评价 Δ

张 颖 ，李志平 ，高雨秋 ，王加良 ，侯甲福（1. 牡丹江医学院附属红旗医院药学部，黑龙江 牡丹江
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157011；2.牡丹江医学院药学院，黑龙江 牡丹江 157011）
中图分类号 R917 文献标志码 A 文章编号 1001-0408（2022）18-2230-05
DOI 10.6039/j.issn.1001-0408.2022.18.11

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＞0.999 0）；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。
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

Establishment of quantitative analysis of multi-components by single marker and quality evaluation of
Gushen dingchuan pills
ZHANG Ying ，LI Zhiping ，GAO Yuqiu ，WANG Jialiang ，HOU Jiafu（1. Dept. of Pharmacy，Hongqi Hospital
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Affiliated to Mudanjiang Medical University，Heilongjiang Mudanjiang 157011，China；2. School of Pharmacy，
Mudanjiang Medical University，Heilongjiang Mudanjiang 157011，China）
ABSTRACT 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＞0.999 0）. 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.
KEYWORDS Gushen dingchuan pills；multi-index component；QAMS method；chemical pattern recognition analysis

固肾定喘丸由肉桂、熟地黄、车前子、盐补骨脂、附 温肾助阳、纳气平喘，为君药；附片和肉桂补肾阳、固肾
片、盐益智仁等13味中药饮片加工而成，方中盐补骨脂 定喘，盐益智仁和金樱子肉温，补脾肾，合为臣药；熟地
黄、山药、茯苓、牡丹皮和泽泻滋补肾阴、渗湿热，车前子
Δ 基金项目 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） 和牛膝利水渗湿、补肝肾，合为佐药；砂仁化湿开胃、温
＊第一作者 主管药师，硕士。研究方向：药物质量控制及方剂学。 脾止泻，为使药。固肾定喘丸可温肾纳气、健脾化痰，临
E-mail：261559591@qq.com
床主要用于治疗肺脾气虚、肾不纳气所致的咳嗽和气
# 通信作者 主管药师，硕士。研究方向：药物质量控制及医院药
学。电话：0453-6582800-2220。E-mail：nuiz00@163.com 喘，亦可用于慢性支气管炎、肺气肿、支气管哮喘而引起

·2230· China Pharmacy 2022 Vol. 33 No. 18 中国药房 2022年第33卷第18期