目的 考察浙贝母、天麻和红景天最细粉的质量稳定性.方法 采用常温留样实验考察,连续追踪12个月,比较不同时间的3种中药最细粉的形貌结构、粒径、比表面积、堆密度、休止角等粉体学特征以及有效成分的量和体外溶出曲线.结果 经过12个月的常温留样实验,浙贝母、天麻和红景天最细粉的粉体学特征没有发生显著性改变,3种中药最细粉的有效成分的量基本保持不变,体外溶出率曲线的差异性很小,具有等价性.结论 浙贝母、天麻和红景天最细粉,在12个月的常温留样实验考察期内,质量稳定性良好.

Objective To investigate the stability of superfine powder of Fritillariae Thunbergii Bulbus (FTB), Gastrodiae Radix (GR), and Rhodiolae Crenulateae Radix et Rhizoma (RCRR). Methods The superfine powder of FTB, GR, and RCRR was prepared and stored at room temperature for 12 months. We investigated the powder characteristics for the particle size, powder morphology, specific surface area, bulk density, and angle of repose. Furthermore, the content and in vitro dissolution of effective ingredients were quantified to evaluate the stability of superfine powder of FTB, GR, and RCRR. Results After storing at room temperature for 12 months, there were little differences between the superfine powder in physicochemical characteristics. The effective ingredient content of superfine powder was essentially unchanged and the in vitro dissolution rate curve remained the same. Conclusion After storing at room temperature for 12 months, the stability of FTB, GR, and RCRR superfine powder is good, which provides the experimental references for the further study of the superfine powder of Chinese materia medica.

四川省中药研究促进会重点合作项目