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Babao Dan capsule (BBDC) is a state secrecy traditional Chinese medicine patent prescription (TCMPP) that is widely used for hepatobiliary and urinary diseases. However, its quality uniformity evaluation (QUE) is lacking. It is necessary to develop a novel and multi–dimensional QUE strategy for BBDC based on chemical properties and bioactivities. An ultrahigh performance liquid chromatography–triple quadrupole–mass spectrometry (UHPLC–QQQ–MS/MS) was developed to quantify 14 compounds, and a QUE strategy was to assess intra–batch and inter–batches consistency. Furthermore, the anti-inflammatory activities were measured in vitro by RAW264.7 cell and NF-κB-RE-luc HEK293 cell. The results indicated that 14 compounds from 16 samples (10 batches) were accurately quantified. And the intra–batch consistency values were less than or equal to 20.1%, whereas the largest inter–batches consistency value was 167.5% of glycocholic acid. 10 batches were divided into three categories to distinction inter–batches differences. BBDC had anti-inflammatory activities including inhibition of LPS–induced NO production and TNF α–activated luciferase counts. The NO inhibition difference of 10 batches was 10.87 μM and accounted for 49.8%. Briefly, the anti-inflammatory activities of 10 batches were different, but the dynamic trends within the same batch were similar, which was supported by luciferase counts. And the correlation was confirmed that the main compounds related to anti-inflammatory in BBDC were bile acids and saponins. Hence, a QUE strategy for BBDC was proposed to improve quality and ensure efficacy. This strategy can be utilized as a reference for consistency evaluations of TCMPPs.

[Display omitted] • The Quality Uniformity Evaluation strategy was adopted to evaluate the consistencies of Babao Dan capsule (BBDC). • An optimized UHPLC–QQQ–MS/MS method was developed to simultaneously determine the 14 main compounds of BBDC. • The 10 batches were divided into three categories based on the inter–batches consistency. • The anti-inflammatory activities of BBDC were studied and clearly distinguished in vitro by RAW264.7 and NF-ĸB-RE-luc HEK293 cells. • The correlation analysis confirmed that the main chemical compounds related to anti-inflammatory activity in BBDC. Babao Dan capsule (BBDC) is a state secrecy traditional Chinese medicine patent prescription (TCMPP) that is widely used for hepatobiliary and urinary diseases. However, its quality uniformity evaluation (QUE) is lacking. It is necessary to develop a novel and multi–dimensional QUE strategy for BBDC based on chemical properties and bioactivities. An ultrahigh performance liquid chromatography–triple quadrupole–mass spectrometry (UHPLC–QQQ–MS/MS) was developed to quantify 14 compounds, and a QUE strategy was to assess intra–batch and inter–batches consistency. Furthermore, the anti-inflammatory activities were measured in vitro by RAW264.7 cell and NF-κB-RE-luc HEK293 cell. The results indicated that 14 compounds from 16 samples (10 batches) were accurately quantified. And the intra–batch consistency values were less than or equal to 20.1%, whereas the largest inter–batches consistency value was 167.5% of glycocholic acid. 10 batches were divided into three categories to distinction inter–batches differences. BBDC had anti-inflammatory activities including inhibition of LPS–induced NO production and TNF α–activated luciferase counts. The NO inhibition difference of 10 batches was 10.87 μM and accounted for 49.8%. Briefly, the anti-inflammatory activities of 10 batches were different, but the dynamic trends within the same batch were similar, which was supported by luciferase counts. And the correlation was confirmed that the main compounds related to anti-inflammatory in BBDC were bile acids and saponins. Hence, a QUE strategy for BBDC was proposed to improve quality and ensure efficacy. This strategy can be utilized as a reference for consistency evaluations of TCMPPs. [ABSTRACT FROM AUTHOR]