中文摘要：

研究喷雾干燥过程条件对三七总皂苷-丹参酮ⅡA复合粒子理化性质及肺部吸入性能的影响。根据复合粒子中这两类成分的理化性质，本研究选择了3个溶剂系统：无水乙醇、无水乙醇-丙酮体积比分别为9：1和4：1；3个进口温度：110℃、120℃、130℃。在不同的溶剂系统及进口温度条件下制备了7种复合粒子，利用扫描电镜（SEM）、X射线衍射（XRD）、动态水蒸气吸附仪（DVS）、原子力显微镜（AFM）和高效液相色谱（HPLC）对复合粒子进行表征，并利用新一代雾粒分布仪（NGI）对复合干粉粒子的空气动力学行为进行评估。结果表明，在采用混合溶剂系统无水乙醇-丙酮体积比9：1、进口温度110℃条件下，所得复合粒子表面粗糙，粒子外层分布有较多的丹参酮IIA微晶颗粒，此种复合粒子肺部可吸入性较好，有效细粉分布比例（VVV值）接近60％。实验证明，采用共喷雾干燥的方法，通过调节喷雾干燥过程条件，可改变丹参酮IIA在粒子外层的分布量及存在形式，从而提高药物复合粒子的肺部可吸入性。

英文摘要：

This study is to report the influence of conditions in spray drying process on physical and chemical properties and lung inhaling performance of Panax notoginseng Saponins - Tanshinone II A composite particles. According to the physical and chemical properties of the two types of components within the composite particles, three solvent systems were selected including ethanol, ethanol ： acetone （9 ： 1, v/v） and ethanol ： acetone （4 ： 1, v/v）, and three inlet temperature： 110 ℃, 120 ℃, 130 ℃ to prepare seven different composite particle samples; each sample was characterized using laser diffraction, scanning electron microscopy （SEM）, dynamic vapour sorption （DVS） and atomic force microscope （AFM）, and their aerodynamic behavior was evaluated by a Next Generation Impactor （NGI）. The results indicate that under the conditions of using the mixed solvent system of ethanol - acetone volume ratio of 9 ： l, and the inlet temperature of 110 ~C, the resulting composite particles showed rough surface, with more tanshinone II A distributing in the outer layer, such composite particles have the best lung inhaling performance and the fine particle fraction （FPF） close to 60%. Finally it is concluded thatby adjusting the conditions in co-spray drying process, the distribution amount and existence form of tanshinone II A in the outer layer of the particles can be changed so that to enhance lung inhaling performance of the drug composite particles.