OBJECTIVE:To study the stability of Fuke zhidai capsule at accelerated testing and room temperature. METHODS: HPLC was conducted to determine the content of berberine hydrochloride in the preparation: the column was Diamonsil C18 with mobile phase of B methanol -0.7% triethylamine(pH adjusted to 3 by phosphate)(50 ∶ 50,V/V) at a flow rate of 1 ml/min; detection wavelength was 265 nm, with a column temperature at 45 ℃, and the injection volume was 5 μl; its moisture, disintegration time, accelerated stability and long-term stability were studied according to the 2015 edition of Chinese Pharmacopoeia. RESULTS: The linear range of berberine hydrochloride was 0.0217-0.1736 mg/ml(r=0.999 9); RSDs of precision, stability and reproducibility tests were lower than 2%; recovery was 97.24%-101.73%(RSD=1.72%,n=6). CONCLUSIONS:The moisture, disintegration time, accelerated stability and long-term stability were all in line with the quality standards.