薬理と治療

Abstract

Objective　Owing to its vast health benefit, the usage of Kaempferia parviflora rhizome in contemporary medicine and as health supplement is growing in popularity worldwide. Parallel with the effort to regulate and standardize herbal ingredient for health industry, the assessments on the safety of SIRTMAX® which is a K. parviflora rhizome extract standardized with polymethoxyflavonoid was conducted. Methods　The safety of SIRTMAX® is assessed for its mutagenicity, as well as evaluation in animals and human clinical trials. Results　Analysis revealed that SIRTMAX® is non-mutagenic. Acute oral toxicity study in mice revealed that the LD50 of SIRTMAX® is no less than 2000 mg╱kg of body weight. While, 90-day repeated oral dose toxicity study in rats revealed that the no-observed-adverse-effect-level（NOAEL）for SIRTMAX® to be 500 mg/kg/day. Furthermore, two human clinical studies on the ingestion of 100 mg/day of SIRTMAX® for seven weeks, and the ingestion for 100 mg╱day of eight weeks followed four weeks of excessive ingestion of SIRTMAX® at 500 mg/day did not result in adverse event. Conclusion　Taken together, all the safety studies conducted on SIRTMAX® strongly suggest that SIRTMAX® is safe for human use.（Jpn Pharmacol Ther 2022；50：1889‒99）