Shandong Science

   

Study on the neutralization method for the antibacterial activity of Phellodendri chinensiscortex Chinese medicine formula granules

AN Chunyan, ZHAO Yiyi, CHEN Zhuo, NIU Zhendong*   

  1. Beijing Institute for Drug Control (Beijing Center for Vaccine Control), NMPA Center for Innovation and Research in Regulatory Science, Beijing 102206, China
  • Received:2026-01-09 Accepted:2026-05-11 Online:2026-07-14
  • Contact: NIU Zhendong E-mail:dividniu@163.com

Abstract: To explore neutralization methods for antibacterial activity of Phellodendri chinensiscortex Chinese medicine formula granules (CMFG) as well as to provide theoretical and data support for the quality control of antibacterial CMFG and the improvement of pharmaceutical standards, different approaches were used to eliminate the antibacterial activity ofP. chinensiscortex CMFG. Two microbial enumeration methods (plate-count, PC, and membrane filtration, MF), two neutralizers (a combination of 3% polysorbate 80 and 0.3% lecithin, and 10% hydroxypropyl-β-cyclodextrin, HP-β-CD), and three dilution levels (1:10, 1:100, and 1:500) were used in this study. Recovery ratios of five test strains were measured for each combination. Results revealed that at lower dilution levels of 1:10 and 1:100, neither PC nor MF methods with either neutralizers could achieve acceptable inoculum recovery ratios (0.5~2.0) forStaphylococcus aureusandCandida albicans. At higher dilution level of 1:500, 3% polysorbate 80 and 0.3% lecithin combined with the PC method could not completely neutralize the antibacterial components inP. chinensiscortex CMF againstC. albicans, and only when combined with the MF method could the recovery ratio meet the required range (0.5~2.0). Conversely, HP-β-CD at the dilution level of 1:500 achieved satisfactory recovery ratios (0.5~2.0) for all five strains when the PC method was used. Accordingly, a microbial examination method for P. chinensiscortex CMFG compliant with theChinese Pharmacopoeia2025 was established. This method has been validated as stable and reliable, providing robust data support for refining its quality standards. Moreover, the effectiveness of the two neutralizers provides a practical reference for neutralizing the antibacterial activity of traditional CMFG with inherent antibacterial properties.

Key words: Phellodendri chinensiscortex, Chinese medicinal formula granule, microbial limit, antibacterial activity, neutralizer

CLC Number: 

  • R 917

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