药学学报, 2013, 48(6): 925-932
引用本文:
王华美, 付廷明, 郭立玮. 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的影响[J]. 药学学报, 2013, 48(6): 925-932.
WANG Hua-mei, FU Ting-ming, GUO Li-wei. The influence of spray drying process conditions on physical, chemical properties and lung inhaling performance of Panax notoginseng saponins − tanshinone Ⅱ A composite particles[J]. Acta Pharmaceutica Sinica, 2013, 48(6): 925-932.

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的影响
王华美, 付廷明, 郭立玮*
(南京中医药大学, 中药复方分离工程重点实验室, 江苏 南京 210029)
摘要:

研究喷雾干燥过程条件对三七总皂苷丹参酮A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9141; 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91、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A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 (FPF) 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A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。

关键词:   
The influence of spray drying process conditions on physical, chemical properties and lung inhaling performance of Panax notoginseng saponins − tanshinone Ⅱ A composite particles
Abstract:

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, ethanolacetone (91, v/v) and ethanolacetone (41, 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 91, and the inlet temperature of 110 , 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 ?ne particle fraction (FPF) close to 60%.  Finally it is concluded that by 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.

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