Study on Quality Standard of Shenhuang Liniment / 中国药房

ABSTRACT

OBJECTIVE： To provide reference for the establishment of quality standard of Shenhuang liniment. METHODS： Qualitative identification of Sophora flavescens， Phellodendron chinense， Rhei Radix Et Rhizoma and Scutellaria baicalensis in Shenhuang liniment were carried out by TLC according to the method of 2015 edition of Chinese Pharmacopeia （part Ⅳ）. HPLC method was used to determine the contents of matrine and oxymatrine in Shenhuang liniment [Phenomenex Luna NH2 column， mobile phase consisting of acetonitrile-absolute ethanol-3％ phosphoric acid aqueous solution （80 ∶ 10 ∶ 10，V/V/V）， column temperature of 45 ℃， flow rate of 1.0 mL/min， detection wavelength of 220 nm， sample size of 5 μL]. RESULTS： Results of TLC showed that the corresponding spots of the same color were found in the corresponding positions of the chromatograms for test samples and reference substance/substance control； and the spots were clear， retardation factor was moderate， the separation degree was high， and the negative control had no interference. Results of HPLC showed that the linear range of matrine and oxymatrine were 203.60-1 221.60 ng（r＝0.999 4）and 210.08-840.30 ng（r＝0.999 7）， respectively. RSDs of precision， stability and reproducibility tests were all lower than 3.0％ （n＝6）. Average recovery rates were 96.03％ and 100.93％， and RSDs were 2.55％ and 2.69％（n＝9）. CONCLUSIONS： Established method is specific， accurate and reproducible， and can be used for quality control of Shenhuang liniment.