Detection of Adulterated Fritillaria thunbergii Miq.in Juhong Pills Based on National Drug Sampling and Testing
10.3870/j.issn.1004-0781.2025.09.007
- VernacularTitle:基于国家药品抽检的橘红丸中浙贝母掺伪投料研究
- Author:
Ping XUE
1
;
Xiaolu ZHANG
;
Jiali ZHANG
;
Qiangyan HUANG
;
Zhengrong GU
;
Minhong LIU
;
Jialiang ZHU
Author Information
1. 常州市食品药品纤维质量监督检验中心,常州市生物制造产品质量检测与风险控制重点实验室,常州 213000
- Publication Type:Journal Article
- Keywords:
Juhong pills;
Fritillaria thunbergii Miq.;
Fritillaria hupehensis Hsiao et K.C.Hsia;
Quality control;
Adulterated material input
- From:
Herald of Medicine
2025;44(9):1410-1417
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a method for the simultaneous determination of peimine,peiminine,and hupehenine in Juhong pills,to investigate the raw material usage of Fritillaria thunbergii Miq.,and to preliminarily develop a detection approach for identifying adulteration with Fritillaria hupehensis Hsiao et K.C.Hsia.Methods The high-performance liquid chromatography-triple quadruple mass spectrometry(HPLC-MS/MS)was performed on an Agilent Poroshell 120 SB C18 column(2.1 mm×100 mm,2.7 μm)with a mobile phase consisting of acetonitrile-methanol(1∶1)and 0.1%formic acid under gradient elution.The flow rate was set at 0.3 mL·min-1.The column temperature was maintained at 35℃,and the injection volume was 2 μL.Electrospray ionization(ESI)in positive ion mode and multiple reaction monitoring were employed to quantify the three components in 170 batches of Juhong pills.Simulated positive samples with varying adulteration ratios of Fritillaria hupehensis Hsiao et K.C.Hsia were prepared to establish a simple yet efficient detection limit for adulteration.Results Three components showed good linear correlation within their ranges(r≥0.997 5),and the averaged recoveries ranged from 92.0%-106.2%.A total of 61 batches were suspected of Fritillaria thunbergii Miq.adulteration with Fritillaria hupehensis Hsiao et K.C.Hsia in raw material inputs,with the peimine to peiminine ratio below 1.15.Among these samples,27 batches were large honey-bound pills with hupehenine levels of 2.636-9.939 μg·g-1;34 batches were water-honeyed pills showing significantly higher hupehenine contamination at 6.752-48.137 μg·g-1.Conclusion The established method is simple,reliable,and accurate for the quality control of Fritillaria thunbergii Miq.adulteration in Juhong pills without imposing significant additional costs.
