Establishment of an anti-inflammation-based bioassay for the quality control of the 13-component TCM formula (Lianhua Qingwen)

建立以抗炎为基础的生物测定方法对十三味中药复方(连花清瘟)进行质量控制

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作者:Shuaishuai Chen, Xiaojuan Yang, Ziying Wei, Yanru Zhang, Ying Huang, Zhuo Shi, Ziteng Zhang, Jiabo Wang, Haizhu Zhang, Jianli Ma, Xiaohe Xiao, Ming Niu

Conclusions

A well-established bioassay may have promising ability to reveal the variance in quality of TCM.

Methods

Network pharmacology was used to screen potential targets in LHQW with respect to its anti-inflammatory effects. An in vitro cell model was used to validate the prediction. An anti-inflammatory bioassay was established for the quality evaluation of LHQW in 40 batches of marketed products and three batches of destructed samples.

Objective

Lianhua Qingwen capsule (LHQW) was selected as an example to discuss the feasibility of a bioassay for quality control. Materials and

Results

The tumor necrosis factor/interleukin-6 (TNF/IL-6) pathway via macrophage was selected as the potential target of LHQW. The IC50 value of LHQW on RAW 264.7 was 799.8 μg/mL. LHQW had significant inhibitory effects on the expression of IL-6 in a dose-dependent manner (p < 0.05). The anti-inflammatory biopotency of LHQW was calculated based on the inhibitory bioactivity on IL-6. The biopotency of 40 marketed samples ranged from 404 U/μg to 2171 U/μg, with a coefficient of variation (CV) of 37.91%. By contrast, the contents of forsythin indicated lower CV (28.05%) than the value of biopotency. Moreover, the biopotencies of destructed samples declined approximate 50%, while the contents of forsythin did not change. This newly established bioassay revealed a better ability to discriminate the quality variations of LHQW as compared to the routine chemical determination. Conclusions: A well-established bioassay may have promising ability to reveal the variance in quality of TCM.

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