Study on Improvement of Quality Standard for Sophora Flos Carbonisatus in Chinese Pharmacopoeia (2015) / 世界科学技术-中医药现代化

ABSTRACT

In order to ef fectively control the quality ofSophora lfos carbonisatus (flower and flower buds), this study established quality control methods and standard of the decoction pieces. Referring to the related methods in appendix of Chinese Pharmacopoeia (2010 Edition), the moisture, total ash, acid insoluble ash, alcohol extracts ofSophora lfos carbonisatus were measured, respectively, with rutin, quercetin as control substance. The eluents for rutin and quercetin are ethyl acetate - formic acid - water (8 11) and chloroform - methanol - water (6.511), respectively and all TLC plates were observed at 365 nm. Total flavonoids are measured by visible - UV - spectrophotometric, and rutin and quercetin were determined by HPLC. The chromatographic conditions for rutin are Kromasil C18 as the stationary phase, methanol -1% acetic acid (3268) as mobile phase, flow rate 0.8 mL·min-1, detection wavelength 257 nm,the column temperature 35℃; for quercetin Kromasil C18 as the stationary phase, methanol -0.4% acetic acid (4456) as the mobile phase, flow rate 0.8 mL·min-1, detection wavelength 257 nm, the column temperature 40℃.The contents of moisture, total ash, acid insoluble ash, should not exceed 6%, 16%, 8.0% in flower and not exceed 6.0%,9.0%, 1.5% in buds, respectively. Under the conditions of TLC, in flower and flower buds, 2 reference substances can be separated well with others. Extract, total flavonoids, rutin, quercetin were no lower than 40.0%, 5.0%, 2.5%,0. 2% in flower and no lower than 45.0%, 10.0%, 5.0%, 0.9% in buds, respectively. The established standards can improve the levels of quality control, provide experimental data for safety and efficacy of clinical application of Sophora flos carbonisatus, and also offer supporting data for the Chinese Pharmacopoeia 2015 Edition.