Study on Quality Standard for Ruheneixiao Soft Capsules

OBJECTIVE:To establish the quality standard for Ruheneixiao soft capsules.METHODS:Radix Paeoniae Rubra,Radix Angelicae Sinensis and Spica Prunellae were identified using TLC.The content of Paeoniflorin in Ruheneixiao Soft Capsules was determined with HPLC.HPLC analytical method was carried out using a C18 column and a mixture containing 13 volume of acetonitrile and 87 volume of water as the mobile phase.The detection wavelength was set at 230nm.RESULTS:Spots obtained from the test solutions had the same color in reference solution and medical material in the same location,and the blank solution had no interference.The linear range of Paeoniflorin was from 5.1 to 40.8mg· mL-1(r=0.997 7)and the average recovery was 98.91%(RSD=0.34%,n=5).CONCLUSIONS:The TLC method produced distinctive spots,and was highly specific for use in the determination of Ruheneixiao soft capsules.The HPLC method was simple and fast,with high accuracy and precision.The standard can be used for the quality control of the drug.