Center of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou, China, 2 Key Laboratory of Drug Safety Evaluation and Research of Zhejiang Province, Hangzhou Medical College (Zhejiang Academy of Medical Sciences), Hangzhou, 310053, China.
The Research Center of Chiral Drugs, Innovation Research Institute of Traditional Chinese Medicine (IRI), Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
J Ethnopharmacol. 2022 Jan 30;283:114670. doi: 10.1016/j.jep.2021.114670. Epub 2021 Oct 12.
Fritillariae thunbergii Miq (FTM)exhibit versatile biological activities including the significant antitussive and expectorant activities. As a herbal medicine, the therapeutic effects of FTM may be expressed by multi-components which have complicated integration effects on multi-targets. With the time going, the different processing methods of FTM has been changed a lot. Thus，the study described the effect of processing methods to FTM and its quality.
Studies were undertaken by using UHPLC-LTQ Orbitrap MS and pharmacodynamic models. All reagents were involved of analytical grade. While a HPLC-ELSD's method has been developed and validated, a certified Quality System is conformed to ICH requirements. The experimental animals followed the animal welfare guidelines.
We aimed to found the differences after the different processing methods of FTM, and to demonstrate the changes could be selected as quality control indicators, and established a method for simultaneous determination of these for quality control.
we have previously found two new steroidal alkaloids: zhebeininoside and imperialine-3-β-D-glucoside from the different processing methods of FTM, which is the difference between the different processing methods of FTM, mainly on the steroidal alkaloids. The activity analysis of zhebeininoside, imperialine-3-β-D-glucoside, verticine and verticinone showed that the mouse model of cough expectorant has antitussive effect. The positive drug selected was dextromethorphan syrup. The positive group showed biological activity, but the blank group showed nothing. The model group showed illness which means that the model was effective. There are two ways of the mechanism of action of the expectorant action which can make sputum thin, reduce its viscosity, and be easy to cough up, or can accelerate the movement of mucous cilia in the respiratory tract and promote the discharge of sputum. In our study, the content of phenol red was significantly reduced in the administration group.
To sum up, our results suggest that zhebeininoside and other three components cloud be selected as quality control indicators, and a method for simultaneous determination of zhebeininoside and other three components was established for quality control.
百合科贝母属植物（FTM）具有多种生物活性，包括显著的镇咳和祛痰作用。作为一种草药，FTM 的治疗效果可能通过多成分表达，这些成分对多个靶点具有复杂的综合作用。随着时间的推移，FTM 的不同加工方法已经发生了很大的变化。因此，本研究描述了加工方法对 FTM 及其质量的影响。
采用 UHPLC-LTQ Orbitrap MS 和药效学模型进行研究。所有试剂均为分析纯。建立了一种 HPLC-ELSD 方法，并符合 ICH 要求的认证质量体系。实验动物遵循动物福利准则。
我们旨在发现 FTM 不同加工方法后的差异，并证明这些变化可以作为质量控制指标选择，并建立一种同时测定这些指标的方法用于质量控制。
我们之前从 FTM 的不同加工方法中发现了两种新的甾体生物碱：浙贝宁苷和去氧浙贝宁苷-3-β-D-葡萄糖苷，这是 FTM 不同加工方法之间的差异，主要在甾体生物碱上。浙贝宁苷、去氧浙贝宁苷-3-β-D-葡萄糖苷、浙贝甲素和浙贝乙素的活性分析表明，它们对小鼠咳嗽祛痰模型具有镇咳作用。阳性药物选择的是右美沙芬糖浆。阳性组表现出生物活性，而空白组则没有。模型组显示疾病，表明模型有效。祛痰作用的作用机制有两种，可以使痰液变稀，降低其粘度，易于咳出，或可以加速呼吸道内的黏液纤毛运动，促进痰液排出。在我们的研究中，给药组的苯酚红含量显著降低。
综上所述，我们的研究结果表明，浙贝宁苷等四种成分可以作为质量控制指标，建立了同时测定浙贝宁苷等四种成分的方法，用于质量控制。
