In vitro Release and Stability of Biphenyl Diester Dry Suspension / 中国药师

ABSTRACT

Objective:To investigate the in vitro release behavior and stability of diphenyl diester suspension. Methods:The dis-solution of biphenyl diester dry suspension was detected by HPLC, and the effects of different stirring speed (50, 75, 100 r·min-1 ) and different dissolution media (pH 6. 8 phosphate buffer, 0. 05 mol·L-1 hydrochloric acid solution,water,pH 4. 5 acetate buffer) on dissolution were investigated. The influencing factors testing ( high temperature, high humidity and strong light exposure) , accelerated stability testing[the temperature of (37 ± 5) ℃ and the relative humidity of 76％ ± 5％] and long-term stability testing[(25 ± 3) ℃and the relative humidity of 60％ ± 5 ％] of biphenyl diester dry suspension were carried out. Results:The dissolution behavior of bi-phenyl diester suspension in pH 6. 8 phosphate buffer (50 r·min-1 ) was faster and smoother. The results of influencing factors testing showed that biphenyl diester dry suspension should not be stored under the conditions of high temperature and high humidity. After the samples were stored under the conditions of accelerated testing and long-term stability testing for 6 months, the indicators did not change significantly. Conclusion:The in vitro release of prepared biphenyl diester dry suspension meets the requirements with promis-ing stability.