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目的:制备供肺部吸入给药的三七总皂苷-丹参酮ⅡA复合干粉粒子,探索一种能够使中药复方中多元组分同步到达吸收部位的干粉粒子制备方法。方法:采用喷雾干燥法制备三七总皂苷-丹参酮ⅡA复合粒子,利用扫描电镜(SEM)、激光共聚焦显微(CLSM)、X-射线衍射(XRD)、红外分析(IR)、干法激光粒度分析、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:所制得的干粉粒子具有较窄的粒径分布范围,良好的空气动力学行为,能实现多组分药物同步给药。结论:利用喷雾干燥的方法能够将理化性质差异大的中药组分结合在同一个粒子中,制成符合吸入给药要求的中药复合粒子。
OBJECTIVE: To prepare dry powder of Panax Notoginseng Saponins ⅡA for pulmonary inhalation and to explore a method for preparing dry powder particles that can synchronously reach the absorption site of multiple components of traditional Chinese medicine. Methods: The total saponin-tanshinone ⅡA composite particles were prepared by spray-drying method and characterized by SEM, CLSM, XRD, IR, Particle size analysis and high performance liquid chromatography (HPLC) were used to characterize the composite particles. The aerodynamic behavior of the composite dry powder particles was evaluated by a new generation of fog particle distribution (NGI). Results: The prepared dry powder particles have narrower particle size distribution, good aerodynamic behavior and can achieve simultaneous administration of multi-component drugs. Conclusion: The spray-drying method can combine the traditional Chinese medicine components with different physical and chemical properties in the same particle to make the traditional Chinese medicine composite particle which meets the requirements of inhalation and administration.