Quality control standard for Xingnaosu capsules

OBJECTIVE:To establish the quality control standard for Xingnaosu capsules.METHODS:The contents of Astragaloside Ⅳ in three batches of pilot sample were determined by HPLC-ELSD.Kromasil C18 column(4.6 mm×250 mm,5 μm)was used.The mobile phase was acetonitrile-water(32∶68) at a flow rate of 0.6mL/min.The flow rate N2 in ELSD was 2.4 L·min-1.The temperature of drift tube was 100 ℃.The main ingredients in the prescription were identified by TLC.RESULTSThe average contents of astragaloside Ⅳ in this three batches of pilot sample were 0.176 6 mg/capsule,0.178 6 mg/capsule,0.1806 mg/capsule respectively.Qualitative identification by TLC for five ingredients in the prescription including astragalus membranaceus,Radix Paeoniae Rubra,Flos Carthami,Semen Persicae,Rhizoma Chuanxiong were established successfully.CONCLUSION:According to the results of determination,the tentative contents of astragaloside Ⅳ(C41H68O14) in each capsule,should not be less than 0.14 mg(taking 80% of the average content of three batches to be the lower limit).The experimental results indicated that the qualitative identification method is simple,scientific,objective,and specific.