Quality standard for Compound Tougucao Solution / 中成药

ABSTRACT

AIM To establish the quality standard for Compound Tougucao Solution [Impatiens balsamina L.Zanthoxylum bungeanum Maxim.,Gleditsia sinensis Lam and Momordica cochinchinensis (Lour.) Spreng.].METHODS The fingerprints of ten batches of samples were established,after which TLC was used for the qualitative identification of I.balsamina and Z.bungeanum,HPLC was adopted in the content determination of quercetin.RESULTS There were twenty-seven common peaks in the fingerprints with the similarities of 0.978-0.986,four of which were sodium benzoate,rutin,hyperoside and quercetin,respectively.The clear TLC spots were free from negative interference.Quercetin showed a good linear relationship within the range of 1.68-107.6 μg/mL (R2 =0.999 9),whose average recovery was 104.3％ with the RSD of 2.2％.CONCLUSION This stable and reproducible method can be used for the quality control of Compound Tougucao Solution.