Objective: To establish a new technology for Fritillariae Thunbergii Bulbus quality control based on effect-constituent index

with resolving phlegm as the main effects and associated with Fritillariae Thunbergii Bulbus clinical efficacy

and make the new quality control method better promote the development of Fritillariae Thunbergii Bulbus industry. Method: Fritillariae Thunbergii Bulbus samples with different varieties and different origins were collected and the upper and lower limits of active ingredients contents (peimine and peiminine) were determined.The analysis conditions were as follows:Hypersil ODS-3 column (4.6 mm×250 mm

5 μm); with acetonitrile-water-diethylamine (70:30:0.03) as the mobile phase; flow rate at 0.8 mL · min-1; the drift tube temperature of Alltech2000-ELSD detector was 85℃

carrier gas flow rate at 2.2 L ·min-1.In the range of concentrations determined

different concentrations of peimine and peiminine standard solution were prepared.With the concentration of phenol red as the phlegm effect indicator in the mouse tracheal phenol red expectoration experiment

the linear relationship between the mouse phenol red excretion and the mass concentration of peimine and peiminine was analyzed to fit the dose-response equation f(Xi) between peimine

peiminine and resolving phlegm effect indicators.Thus the resolving phlegm effect index was constructed and verified. Result: In the main producing areas of Fritillariae Thunbergii Bulbus

the content of peimine was between 0.046 5%-0.092 5%

and the content of peiminine was between 0.017 5%-0.054 3%.Therefore

the range of dosing solution concentration was:peimine content in the range of 0.04%-0.10% and peiminine content in the range of 0.02%-0.06%.The results of mouse tracheal phenol red expectoration experiment showed that peimine in 0.09-0.23 g · L-1 and peiminine in 0.045-0.135 g·L-1 range had a good linear relationship with the concentration of mouse tracheal phenol red (rpeimine=0.994 7

rpeiminine=0.997 8).The established resolving phlegm effect-constituent index of Fritillariae Thunbergii Bulbus according to the fitted dose-response equation can characterize its expectorant efficacy through the contents of the compositions. Conclusion: The establishment of resolving phlegm effect-constituent index

has not only achieved dose-efficacy correlation

but also achieved the concept of observing effect by the composition contents.Therefore

it has better guiding significance and application prospects for Fritillariae Thunbergii Bulbus quality control assessment

industrial development and clinical rational drug use.