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

RespireAidTM (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 RespireAidTM. In addition, the lot-to-lot efficacy stabilities were also evaluated. We found that RespireAidTM 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 RespireAidTM were consistent, with average 50% scavenging concentrations of 0.22 & PLUSMN; 0.02 mg/mL and 5.76 & PLUSMN; 0.59 mg/mL, respectively. From a comprehensive quality control strategy point of view, RespireAidTM, 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.