清香片的喷雾干燥工艺研究

Drying process of Qingxiang Tablets by spray-drying method

目的:对清香片(地黄、麦冬、白芍等)浸膏的喷雾干燥工艺进行优化。方法:以干粉得率和吸湿百分率为指标,优选了加入浸膏的辅料;采用正交设计法,以复方中的芍药苷的转移率和干粉得率作指标,确定了工艺参数:浸膏相对密度、进风温度和浸膏进料速度。结果:最佳工艺经过验证,其工艺参数为:浸膏中加入的辅料为6%的β-环糊精(β-CD),进风温度为190°C,浸膏进料速度为10 mL/m in,浸膏相对密度为1.12 g/mL。结论:该工艺合理,产品稳定性好,为工业化生产提供了实验依据。

AIM ： To optimize the spray-drying process of Qingxiang Tablets. METHODS： Excipients were selected in terms of hygroscopicity and yield rate of dried powders with several excipients added; then, the process parameters, such as the relative density of fluid extracts, intake temperature, and the input speed of liquid feedstock were optimized by orthogonal experiment, in which the transfer rate of peoniflorin, a constituent in the formulation, and dried powder yield rate were set up as the evaluation index. RESULTS： The optimal processing conditions were obtained and validated as follows ： relative density of liquid feedstock was 1.12 mg/mL （ containing 6% β-CD）, the input speed was 10 mL/min and intake temperature was at 190 ℃. CONCLUSION： The optimal process is stable and the experimental results provide the basis of industrial production.