Study on quality standard of Fici Hirtae Radix / 中草药

ABSTRACT

Objective: To control the quality of Fici Hirtae Radix by establishing quality standards. Methods: The origin mistakes of Fici Hirtae Radix in Chinese Pharmacopoeia (1977 edition) were modified by searching and mining plant morphology characters, distribution of origin, historical evolution, clinical efficacy and modern research, medicinal standards in different regions on Ficus hirta Vahl and Ficus simplicissima. Morphological identification, microscopical characteristics based on transverse section and powder, and thin layer chromatography were adopted to identify commercial medicinal materials of Fici Hirtae Radix from different sources. The content of psoralen and bergapten was determined by HPLC. Moisture content, total ash, acid-insoluble ash, and ethanol-soluble extractives were determined by methods described in appendices of Chinese Pharmacopoeia (2010 edition). Results: The origin of Fici Hirtae Radix was not F. simplicissima Lour., but F. hirta Vahl. This study collected 20 Fici Hirtae Radix commercial medicines mixed 40% non-medicinal parts samples. TLC data, morphological characteristics and microscopic characteristics, both showed obvious distinction. The concentration of psoralen and bergapten showed the content of psoralen range from 0.00848% to 0.150%, and the content of bergapten range from 0.00587% to 0.026 3%, and the contents of two index components of Fici Hirtae Radix were significantly higher than the non-medicinal parts samples. The moisture content ranged from 4.73% to 8.27%, total ash ranged for 2.58% to 4.37%, acid insoluble ash ranged for 0.054% to 0.710%, ethanol-soluble extracts ranged for 6.23% to 8.34%. Conclusion: This paper revised the origin error of Fici Hirtae Radix of Chinese Pharmacopoeia (1977 edition) that its specification medicinal part should be the roots of F. hirta, and established quality standards of Fici Hirtae Radix, and these methods could comprehensively and effectively control the quality of commercial medicinal materials of Fici Hirtae Radix. This study could provide evidence for rational, safe, and effective clinical application of Fici Hirtae Radix.