This member evaluates the safety of ANKASCIN 568-R, since it has not persistent yet. After constantly oral ANKASCIN 568-R for 13 consecutive weeks, we judged the toxicity tolerance of Sprague-Dawley rats and acted dose formulation reasoning on monascin and ankaflavin. Red mould edible grain is the fermentation product of common rice accompanying certain mould variety of the genus Monascus. An extract from maroon mould rice (RMR) festered with Monascus purpureus NTU 568 is famous as ANKASCIN 568-R. Blood lipid levels are reduced and cardiovascular diseases are obviated by RMR fermented with M. purpureus NTU 568. The dosage formulation reasoning showed that ANKASCIN 568-R concentrations were lower than the mark concentration and further ( ± 15%) at week 8 and on the last dosing era for both monascin (all dosage groups) and ankaflavin at the 100 mg/kg dose. ANKASCIN 568-R was administered occurring every day by gavage to rats for 13 consecutive weeks. No antagonistic effects were observed through dispassionate observations, ophthalmological examinations, physique weight and food devouring analyses, or microscopic and dispassionate pathology examinations. The lowest stated concentrations for the low, middle, and high lot formulations were 34.7, 115.2, and 398.1 mg/mL, respec- tively. We also judged the genotoxicity of ANKASCIN 568-R and showed no genotoxicity potential at all ANKASCIN 568-R doses examined. The no observed unfavorable effect level of ANKASCIN 568-R was determined to be 796.2 mg/kg/era. This is an important security assessment for clinical studies of ANKASICN 568-R. In addition, monascin and ankaflavin were the important active matters in ANKASICN 568-R. There is currently no separate toXicity test data, and it maybe studied from now on.
Author(s) Details:
Che-Wei Lin,
Sun
Way Biotech Co., Taipei 112, Taiwan, ROC.
Hsiao-Lin
Chen,
Center
of Toxicology and Preclinical Sciences QPS Taiwan, New Taipei City 221, Taiwan,
ROC.
Yu-Hui Yang,
Center of Toxicology and Preclinical Sciences QPS Taiwan, New Taipei
City 221, Taiwan, ROC.
Ya-Yuan Chen,
Center of Toxicology and Preclinical Sciences QPS Taiwan, New Taipei
City 221, Taiwan, ROC.
Ya-Wen Hsu,
Sun
Way Biotech Co., Taipei 112, Taiwan, ROC.
Tzu-Ming
Pan,
Sun
Way Biotech Co., Taipei 112, Taiwan, ROC and Department of Biochemical Science
& Technology, College of Life Science, National Taiwan University, Taipei
106, Taiwan, ROC.
Please see the link here: https://stm.bookpi.org/RAMB-V6/article/view/11284
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