目的 从6个代表性生物碱含量、体外化痰生物效价和体内止咳祛痰作用等3个方面综合量化评价6个基原川贝母的质量一致性。方法 基于高效液相色谱-蒸发光散射检测器新建立了一种川贝母中6种生物碱（西贝母碱苷、西贝母碱、贝母辛、贝母素甲、贝母素乙、梭砂贝母碱）的同时定量分析方法；选择铜绿假单胞菌P.aeruginosa和金黄色葡萄球菌S.aureus作为人工痰液的培养菌，制备含菌人工痰液，与川贝母混合后在0、30、60、90、120 min测定黏度值，以期从体外化痰生物活性的角度评价川贝母的质量差异；基于氨水引咳、气管酚红排泌2种小鼠动物模型，分别比较川贝母样品（1.802 g·kg^-1）的止咳和祛痰作用，以期从体内整体药效作用的角度评价川贝母的质量差异。结果 定量分析结果显示，6个生物碱类化学成分在23批次川贝母样品中的含量较低，部分样品中西贝母碱苷、西贝母碱、贝母素甲、贝母素乙、梭砂贝母碱的含量低于检测限。以不同基原川贝母样品中6个生物碱总量平均值比较，高低顺序如下：瓦布贝母（0.190 4%） ＞太白贝母（0.048 9%） ＞梭砂贝母（0.024 0%） >川贝母（0.020 6%） ＞甘肃贝母（0.008 7%） ＞暗紫贝母（0.007 5%），表明以化学评价6个基原川贝母的质量一致性时，存在较大差异。以不同基原川贝母样品的平均化痰生物效价比较，效价高低顺序如下：瓦布贝母（1 560 U·g^-1） ＞甘肃贝母（1 135 U·g^-1） >太白贝母（953 U·g^-1） ＞暗紫贝母（838 U·g^-1） >川贝母（805 U·g^-1） ＞梭砂贝母（670 U·g^-1），表明以体外化痰生物效价评价6个基原川贝母的质量一致性时，存在较大差异。止咳作用实验结果显示，以不同基原川贝母样品止咳作用平均值比较，止咳作用强弱顺序如下：梭砂贝母（13次） ＞暗紫贝母（16次）＞甘肃贝母（18次） ＞川贝母（21次） ＞太白贝母（40次） ＞瓦布贝母（51次），表明以体内止咳作用强度评价6个基原川贝母的质量时，其质量一致性较差。以不同基原川贝母样品祛痰作用平均值比较，祛痰作用强弱顺序如下：梭砂贝母＞瓦布贝母≈甘肃贝母≈太白贝母≈川贝母≈暗紫贝母，表明以体内祛痰作用强度评价6个基原川贝母的质量时，其质量一致性相对较好。结论 6个基原的川贝母样品存在较大的质量差异，亟需进一步加强质量评价研究。

Objective To comprehensively evaluate the quality consistency of six different types of Fritillaria cirrhosa from three aspects: the content of six representative alkaloids, in vitro biological potency, and in vivo cough and phlegm relieving effects. Methods A new simultaneous quantitative analysis method for six alkaloids (siberian lily alkaloid glycoside, siberian lily alkaloid, fritillaria acid, fritillaria acid A, fritillaria acid B, and siberian lily alkaloid) in F. cirrhosa has been established based on high-performance liquid chromatography-evaporative light-scattering detector. Pseudomonas aeruginosa and Staphylococcus aureus were selected as the culture bacteria for artificial sputum preparation. After mixing the artificial sputum containing bacteria with F. cirrhosa, viscosity values were measured at 0, 30, 60, 90, and 120 min, aiming to evaluate the quality differences of F. cirrhosa from the perspective of in vitro expectorant biological activity. Based on two mouse animal models, namely ammonia-induced cough and tracheal phenol red excretion, the cough relieving and expectorant effects of F. thunbergii samples (1.802 g·kg^-1) were compared, aiming to evaluate the quality differences of F. cirrhosa from the perspective of overall pharmacological effects in vivo. Results The quantitative analysis results showed that the content of six alkaloids in 23 batches of samples was relatively low, and the content of target compounds in some samples was below the detection limit. Comparing the average total amounts of six alkaloids in different samples, the order from high to low is as follows: F. unibracteata Hsiao et K. C. Hsiavar. wabuensis (S. Y. Tang et S. C. Yue) Z. D. Liu, S. Wang et S. C. Chen (0.190 4%) > F. taipaiensis P. Y. Li (0.048 9%) > F. delavayi Franch. (0.024 0%) > F. cirrhosa D. Don (0.020 6%) > F. przewalskii Maxim. (0.008 7%) > F. unibracteata Hsiao et K. C. Hsia (0.007 5%), indicating that there are significant differences in evaluating the quality consistency of six different types of F. cirrhosae bulbus using chemical models. Comparing the average expectorant biological potency of the samples, the order from high to low is as follows: F. unibracteata Hsiao et K. C. Hsiavar. wabuensis (S. Y. Tang et S. C. Yue) Z. D. Liu, S. Wang et S. C. Chen (1 560 U·g^-1) > F. przewalskii Maxim. (1 135 U·g^-1) > F. taipaiensis P. Y. Li (953 U·g^-1) > F. unibracteata Hsiao et K. C. Hsia (838 U·g^-1) > F. cirrhosa D. Don (805 U·g^-1) > F. delavayi Franch. (670 U·g^-1), indicating that there are significant differences in the quality consistency of six different types of F. cirrhosae bulbus evaluated by in vitro expectorant biological potency. The results of the cough suppression experiment showed that compared with the average cough suppression effect of different samples, the order from strong to weak is as follows: F. delavayi Franch. (13 times) > F. unibracteata Hsiao et K. C. Hsia (16 times) > F. przewalskii Maxim. (18 times) > F. cirrhosa D. Don (21 times) > F. taipaiensis P. Y. Li (40 times) > F. unibracteata Hsiao et K. C. Hsiavar. wabuensis (S. Y. Tang et S. C. Yue) Z. D. Liu, S. Wang et S. C. Chen (51 times), indicating that when evaluating the quality of six different types of F. cirrhosae bulbus based on the strength of cough suppression effect in vivo, the quality consistency is relatively poor. Comparing the average expectorant effects of different samples, the order from strong to weak is as follows: F. delavayi Franch.> F. unibracteata Hsiao et K. C. Hsiavar. wabuensis (S. Y. Tang et S. C. Yue) Z. D. Liu, S. Wang et S. C. Chen ≈ F. przewalskii Maxim. ≈ F. taipaiensis P. Y. Li ≈ F. cirrhosa D. Don ≈ F. unibracteata Hsiao et K. C. Hsia, indicating that when evaluating the quality of six different types of Fritillaria cirrhosa based on the strength of their expectorant effects in vivo, their quality consistency is relatively good. Conclusion There are significant quality differences among the six types of Fritillaria cirrhosa samples, and further research on quality evaluation is urgently needed.

R965

四川省科技厅科技计划项目（2023YFH0104）；四川省科技厅基本科研项目（2025JDKY0027）；四川省药品检验研究院国国家药品监督管理局中成药质量评价重点实验室开放课题（中成药-2023-KFKT-004）