Overall quality control of the chemical and bioactive consistency of ShengMai Formula

Yuanru Zheng; Chunlin Fan; Menghua Liu; Ye Chen; Zibin Lu; Nishan Xu; Hefei Huang; Huhu Zeng; Shanhong Liu; Huihui Cao; Junshan Liu; Linzhong Yu

doi:10.1016/j.jpba.2020.113411

Overall quality control of the chemical and bioactive consistency of ShengMai Formula

J Pharm Biomed Anal. 2020 Sep 10:189:113411. doi: 10.1016/j.jpba.2020.113411. Epub 2020 Jun 11.

Authors

Yuanru Zheng¹, Chunlin Fan², Menghua Liu³, Ye Chen², Zibin Lu¹, Nishan Xu¹, Hefei Huang¹, Huhu Zeng², Shanhong Liu¹, Huihui Cao¹, Junshan Liu⁴, Linzhong Yu⁵

Affiliations

¹ Traditional Chinese Pharmacological Laboratory, Third Level Research Laboratory of State Administration of Traditional Chinese Medicine, School of Traditional Chinese Medicine, Southern Medical University, Guangzhou, 510515, PR China; Guangdong Provincial Key Laboratory of Chinese Medicine Pharmaceutics, Guangzhou, 510515, PR China.
² Guangdong Province Key Laboratory of Pharmacodynamic Constituents of TCM and New Drugs Research, College of Pharmacy, Jinan University, Guangzhou, 510632, PR China.
³ Guangdong Provincial Key Laboratory of New Drug Screening, School of Pharmaceutical Sciences, Southern Medical University, Guangzhou, 510515, PR China.
⁴ Traditional Chinese Pharmacological Laboratory, Third Level Research Laboratory of State Administration of Traditional Chinese Medicine, School of Traditional Chinese Medicine, Southern Medical University, Guangzhou, 510515, PR China; Guangdong Provincial Key Laboratory of Chinese Medicine Pharmaceutics, Guangzhou, 510515, PR China. Electronic address: liujunshan@smu.edu.cn.
⁵ Traditional Chinese Pharmacological Laboratory, Third Level Research Laboratory of State Administration of Traditional Chinese Medicine, School of Traditional Chinese Medicine, Southern Medical University, Guangzhou, 510515, PR China; Guangdong Provincial Key Laboratory of Chinese Medicine Pharmaceutics, Guangzhou, 510515, PR China. Electronic address: yulzh@smu.edu.cn.

PMID: 32603924
DOI: 10.1016/j.jpba.2020.113411

Abstract

ShengMai Formula (SMF), a famous traditional Chinese medicine (TCM) formula, has been extensively used for treating the diseases caused by Qi-Yin deficiency for almost 1000 years. However, few studies are elucidated about its batch-to-batch quality control system and the quality control markers remain largely unrevealed, which have hindered the development and utilization of SMF. In this study, we aimed to screen the optimal quality control markers to evaluate the overall quality consistency of SMF. High-performance liquid chromatography (HPLC) fingerprint coupled with similarity analysis (SA), principal components analysis (PCA) and hierarchical cluster analysis (HCA) was firstly established to hunt for the discriminant components that resulting in the chemical inconsistence among different batches of SMF. Subsequently, different batches of samples were selected to explore their immunomodulatory activities by neutral red method, Cell Counting Kit-8 (CCK-8) assay and enzyme-linked immunosorbent assay (ELISA). Finally, the fingerprint-efficacy relationships were further illuminated to discover the major bioactive compositions using grey relational analysis (GRA), partial least squares regression (PLSR) analysis and artificial neural network (ANN) analysis. As a result, schisandrol A, schisandrol B, methylophiopogonanone A, schisandrin B, ginsenoside Rf, ginsenoside Rb1, ginsenoside Rg2 and ginsenoside Rb2 were selected as the quality control markers and thus their simultaneous quantification was performed to both evaluate the batch-to-batch chemical and bioactive consistency among different batches of SMF. Our investigation not only stresses the necessity of consistency in efficacy besides chemical consistency, but also provides a comprehensive and powerful quality assessment approach, which is promising to monitor the overall quality consistency of SMF.

Keywords: Fingerprint-efficacy relationship; HPLC fingerprint; Immunomodulatory activities; Quality control marker; ShengMai Formula.

MeSH terms

Chromatography, High Pressure Liquid
Drug Combinations
Drugs, Chinese Herbal*
Medicine, Chinese Traditional
Quality Control

Substances

Drug Combinations
Drugs, Chinese Herbal
fructus schizandrae, radix ginseng, radix ophiopogonis drug combination