Abstract:

A novel multi-components comprehensive evaluation approach in the present research is superior to the conventional single marker-orientation method in being more reasonable and suitable for the demonstration of the chemical stability of Chinese Medicines(CMs). An application of this proposed method on the chemical stability study of fermented red yeast rice, one of traditional Chinese healthcare food and medicines, was addressed. The accelerated testing(40 ℃, 75%RH) for 3 months and the stress testing under five storage conditions involving  high temperature(80 ℃, 60 ℃), high humidity(25 ℃ and 92.5%RH) and high humidity with high temperature(60 ℃ and 75%RH) and light effects were carried out. A complex criteria, given name “variability percentage[V(%)]” was initiated to display the combination of multi-components stability in CM. The results show that variability percentage[V(%)] generated from the sum of monacolin lacton and acid forms was preferred to assess the stability of red yeast rice. This proposed way could be used as technique platform and applied to stability evaluation of other CMs, which could provide detail information on the inter- and intra- varieties of multi-components in CM.

Key words: Red yeast rice; Chemical stability; Monacolins; Complex criteria variability