一种吸入气雾剂及其制备方法
By optimizing the formulation and preparation method of umeclidinium bromide inhalation aerosol, and utilizing the synergistic effect of PVPK25 and polyethylene glycol 1000, the problems of low delivery efficiency and poor stability of umeclidinium bromide inhalation powder aerosol have been solved, resulting in a suspension aerosol with high FPF and low impurity content, suitable for a wider range of patients.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- YANGTAI PHARMA SHANDONG
- Filing Date
- 2025-05-16
- Publication Date
- 2026-07-17
AI Technical Summary
Existing umebromide inhalation powder has problems such as low delivery efficiency and poor chemical and physical stability, especially with a fine particle fraction (FPF) in the range of 26% to 44%, which leads to waste of active ingredients and side effects, and is not suitable for patients with lactose intolerance.
The formulation of the suspension aerosol includes umebromide, PVPK25, polyethylene glycol 1000 and a propellant. By optimizing the ratio and preparation method, the particle size distribution of umebromide is ensured to be 0.1-0.8 μm for D10, 0.6-2.0 μm for D50, and 1.5-5.0 μm for D90, achieving an FPF of over 70% and an impurity content of less than 0.1%.
It improves the delivery efficiency and stability of umebromide inhalation aerosol, with an FPF of over 70% and impurity content of less than 0.1%, ensuring uniform drug delivery and long-term storage.
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