Study on quality control method of Flueggea suffruticosa / 中国药房

ABSTRACT

OBJECTIVE To establish the quality control method of Flueggea suffruticosa. METHODS The microscopical identification and thin layer chromatography （TLC） of F. suffruticosa were carried out， and the mass fractions of moisture， total ash， acid-insoluble ash and alcohol-soluble extracts in F. suffruticosa were measured based on the 2020 version of Chinese Pharmacopoeia （part Ⅳ）. The content of securinine in medicinal materials was determined by high performance liquid chromatography. RESULTS The powder of F. suffruticosa was gray-green， with obvious microscopic characteristics such as pores， pollen grains， calcium oxalate cluster crystals， ducts. The results of TLC identification showed that in the chromatograms of 16 batches of medicinal samples， the same color spots were found on the corresponding positions of the chromatograms of securinine， rutin， quercetin and F. suffruticosa control. The average mass fractions of moisture， total ash， acid-insoluble ash and alcohol- soluble extracts in 16 batches of medicinal materials were 9.26%， 6.96%， 1.17% and 28.89%， respectively. The injection volume of securinine in the range of 0.052 4-0.524 0 µg had a good linear relationship with the peak area （R2＝0.999 8）. RSDs of precision， repeatability and stability （24 h） test were all less than 3% （n＝6 or 7）. The average recovery of sample was 97.47%， RSD was 1.63% （n＝6）. The content of securinine in 16 batches of medicinal materials was 1.003-6.872 mg/g. CONCLUSIONS The quality control method of F. suffruticosa is established， and the mass fractions of moisture， total ash and acid-insoluble ash should not exceed 12.0%， 9.0% and 2.0%， respectively； the alcohol-soluble extract should not be less than 20%， and the content of securinine should not be less than 1.00 mg/g.