Abstract:

The aim of this study was to establish the quality standard of Ruxiankang (RXK) injection. According to the relevant requirements of the Chinese Pharmacopoeia (2015 edition), TLC identification,related substances examination and heavy metal examination method of RXK injection were established and the limits were determined. HPLC method was used to establish the content determination method of liquiritin, ammonium glycyrrhizinate, hesperidin and caffeic acid, and determined the limit. The specificity of Glycyrrhizae Radix et Rhizoma, Citri Reticulatae Pericarpium and Taraxaci Herba was strong. Liquiritin in 0.0459 to 0.7340 μg, ammonium glycyrrhizate in 0.0661 to 1.0580 μg, hesperidin in 0.0592 to 0.9470 μg, caffeic acid in the 0.0384 to 0.6140 μg concentration showed a good linear relationship with peak area. The correlation coefficients were 0.997,0.9990,0.9999 and 1.000,respectively. The average recoveries were 101.25%, 99.87%, 98.39% and 103.49%,respectively. The RSD values were 4.82%, 3.63%, 2.94% and 0.85%,respectively. The contents of liquiritin, ammonium glycyrrhizinate, hesperidin and caffeic acid of RXK injection were not less than 88.90, 138.48, 136.50 and 21.54 μg/mL,respectively. According to the maximum daily dose of RXK injection, Pb,Cd, As, Hg and Cu should not exceed 23,3,6,2 and 150 μg, respectively. The quality standard established in this study could provide reference for controlling the quality of RXK injection.

Key words: RXK injection; TLC identification; quality standard; heavy metal determination