Establishment and Development of a Quality Evaluation Method for Sangbaipi Decoction.

Background: Sangbaipi decoction (SD), a traditional Chinese "Ancient Classical Prescription" consisting of eight medicinal materials, is usually used to treat asthma due to excess lung Qi and phlegm fire.

Objective: To establish a comprehensive quality evaluation method for SD.

Methods: HPLC fingerprint analysis, hierarchical cluster analysis (HCA), and principal component analysis (PCA) were applied for the quality control of SD prepared from different batches of medicinal materials. A total of 10 batches of SD samples were prepared and analyzed.

Results: A total of 24 common peaks and six active components (gardenoside, rutin, berberine, palmatine, baicalein, and wogonin) were identified in the HPLC fingerprint of SD. The ten batches of SD samples were divided into four groups via HCA and PCA. The HPLC fingerprint similarities of the 10 batch samples were 0.934 or higher. The precision, stability, repeatability, and other methodological indexes suggested that the developed method met the requirements for qualitative fingerprint research.

Conclusion: The results indicated that HPLC fingerprints combined with PCA and multicomponent determination can be successfully applied to SD quality control. This study also provides a basis for a more comprehensive quality evaluation method for SD.

Highlights: The fingerprint of SD, a TCM famous classical formula, was established by HPLC in this paper. Moreover, contents of six pharmacodynamic related components in SD were determined simultaneously in order to establish a comprehensive quality evaluation method of SD. This study can also provide a basis for raw material selection, quality evaluation, extraction process, preparation development and pharmacodynamic material basis research of SD.