Application of bioactivity validation as quality control approach: Panax notoginseng dominated scientific-driven new TCM formulae-BPAid from laboratory to industrial scale

Abstract

Background

In the realm of Chinese medicine, quality control and pharmacodynamics are crucial to ensure the consistency in scaled-up process from the laboratory to commercial operations. This study aims to analyse bioactivity consistency between laboratory observations and commercial processes.

Method

The preparation of BPAid (5: 2: 9: 1 for Uncaria rhynchophylla (UR): Pueraria thomsonii (PT): Panax notoginseng (PN): Alisma orientale (AO) was divided into three methods: laboratory-scale maceration (BPAidM), industrial-scale flash extract method (BPAidFE), decoction method (BPAidD). The vasodilatory and antihypertensive effects of the extracts were examined through ex vivo and in vivo studies. The chemical fingerprint of each extract was analysed using tri-step FTIR spectroscopy, and UPLC-MS/MS was used for standard marker quantification.

Results

BPAidM exhibited the highest vasodilatory effect, followed by BPAidFE, and BPAidD with EC₅₀ values of 11.25 ± 2.30 mg/mL, 39.23 ± 12.55 mg/mL, 24.33 ± 6.26 mg/mL, and 198.71 ± 127.21 mg/mL: R_MAX values of 106.53 ± 7.95%, 82.92 ± 5.22%, 76.35 ± 4.51%, and 60.62 ± 5.7%, respectively. In in vivo antihypertensive studies, all extracts significantly reduced the blood pressure of Spontaneously Hypertensive rats (SHRs). The tri-step FTIR revealed the presence of phenolic compounds, esters, and saccharides in BPAid extracts. BPAidM contained the highest total standard marker in the UPLC-MS/MS quantification, followed by BPAidFE, and BPAidD.

Conclusion

Ultimately, the flash extract technique is recommended to produce BPAid to meet the global demand.