Characterization and comparison of Re-Du-Ning aerosol particles generated by different jet nebulizers

Abstract

Inhalation therapy is the first-line therapy for the treatment of respiratory diseases. Re-Du-Ning inhalation solution (RIS) is an aerosol derivative from the Re-Du-Ning injection and has been clinically used to treat respiratory diseases like pneumonia for more than twenty years in China. However, the aerosolization and inhalation performances of RIS using different nebulizers have not been characterized, which may affect the therapeutic effects of RIS on respiratory diseases. We investigated the inhalation performances of RIS using five different nebulizers utilizing Spraytec, breath simulator of BRS 2000 and NGI techniques. We tested 5 different types of jet nebulizer, using RIS and an adult breathing pattern, to determine the difference in aerosol delivery over time. The particle size distribution of RIS was monitored by a Spraytec laser particle sizer. Fine particle fraction (FPF) and mass median aerodynamic diameter (MMAD) for RIS were measured using NGI. Aerosol deposited on the filter was analysed using HPLC. Nebulization time was much longer for the Pari Boy SX (red) nebulizer than for the other nebulizers, with the minimum delivery rate (DR) and the maximum total delivered dose (TDD) and total exhalation dose (TED). Nebulization time for Pari Boy SX (blue) was the lowest, with the highest DR and the lowest TDD and TED. Furthermore, the aerodynamic particle size of RIS was much larger for the Pari blue and Pari LC Plus than other nebulizers. Pari red produced the smallest aerodynamic particle size of RIS in these five nebulizers. In addition, a good linear relationship was found between MMAD and D₅₀ in these five nebulizers. The results demonstrated that Pari Boy SX (red) delivered most slowly and produced the smallest aerodynamic particle size of the RIS aerosols, which may be applied to manage lower respiratory diseases. Moreover, Pari LC Plus and Pari Boy SX (blue) emitted quickly and generated larger aerodynamic particle size of RIS aerosols, which could be used to treat upper respiratory diseases. A good linear relationship between MMAD and D₅₀ showed Spraytec could be a reliable technique for the development, evaluation and quality control of aerosol particles of inhalation solution preparations.