An integrative approach for compressive quality control of RespireAid™, a traditional Chinese medicine formula against SARS-CoV-2

Kun-Teng Wang ^a, Chia-Jung Lee ^b,c, Ming-Chung Lee ^d, Chao-Yu Chen ^a, Yun-Chen Tsai ^e, Wu-Chang Chuang^e,*

^a Herbiotek Co., Ltd., New Taipei City, Taiwan

^b PhD Program in Clinical Drug Development of Herbal Medicine, Taipei Medical University, Taipei, Taiwan

^c Traditional Herbal Medicine Research Center, Taipei Medical University Hospital, Taipei, Taiwan

^d Brion Research Institute of Taiwan, New Taipei City, Taiwan

^e Sun Ten Pharmaceutical Co., Ltd., New Taipei City, Taiwan

RespireAid™ (NRICM101) is an effective anti-SARS-CoV-2 traditional Chinese medicine formula and has been licensed as a drug or dietary supplement in Taiwan, Luxembourg, Australia, Singapore, Cambodia, Philippines, and Canada. In this study, we provided integrated quality control strategy to analyze the ingredient of RespireAid™. In addition, the lot-to-lot efficacy stabilities were also evaluated. We found that RespireAid™ comprised of monosaccharides and disaccharides (34.0%), maltodextrin (23.5%), inorganic elements and ash (12.2%), oligosaccharides and polysaccharides (11.4%), principal components (4.4%), moisture (4.0%), amino acids (3.5%), b-Cyclodextrin (0.25%), menthol (0.25%), and nucleotides (0.14%), while the remainder was unidentified (6.36%). This is the first time that the chemical composition of a complex traditional Chinese medicine was clarified using various analytical instruments. The lot-to-lot anti-oxidation and anti-inflammation efficacies of RespireAid™ were consistent, with average 50% scavenging concentrations of 0.22 ± 0.02 mg/mL and 5.76 ± 0.59 mg/mL, respectively. From a comprehensive quality control strategy point of view, RespireAid™, designed from a traditional Chinese medicine formula, displayed high quality, transparency, and efficacy. This integrated strategy provides a clear and reliable way to evaluate the quality of complex traditional Chinese medicines.

Keywords: Compressive quality control, Integrative approach, Lot-to-lot consistency, Principal components, RespireAid^TM, Traditional Chinese medicine

https://doi.org/10.38212/2224-6614.3467