缬沙坦胶囊处方工艺的筛选及其质量评价

Evaluation on Optimization and Its Quality of Valsartan Capsule Formulation

目的:研制缬沙坦胶囊处方工艺,并考察其对质量控制的影响。方法:采用单因素设计,以体外释放行为为优选指标,筛选处方工艺,并按照优选后的处方工艺制备缬沙坦胶囊;将制成的胶囊在不同条件下分别于0 d、5 d和10 d时取样检测,考察其体外释放行为和稳定性。结果:按优选后的处方-6制得的胶囊,置60℃条件下,测得的体外释放度严重下降,说明缬沙坦胶囊对温度有一定的敏感性。结论:优选后处方,在40℃,90%RH/光照条件下(带包装)制备的缬沙坦胶囊的稳定性符合要求。

Objective:To study the formulation technique of valsartan capsules and its influence on quality control.Methods:The single factor design was used to select the formulation process and to prepare valsartan capsules according to the optimized formulation process, with the in vitro release behavior as the optimal index. The prepared capsules were sampled at 0, 5 and 10 days under different conditions to investigate their release behavior and stability in vitro. Results:The capsule, prepared based on the optimized prescription-6, was placed at 60 ℃, and the measured in vitro release degree decreased seriously, indicating that the valsartan capsule had certain sensitivity to temperature. Conclusion:The stability of the valsartan capsule prepared at 40 ℃ and 90% RH/light(with packaging) were qualified.