The invention relates to an
inhalation dry powder preparation containing a
salmeterol and tiotropium salt composition and a preparation method of the
inhalation dry powder preparation, and belongs to the technical field of pharmaceutical preparations. The preparation comprises a long-acting beta-2
adrenergic receptor agonist (LABA)
salmeterol and a long-acting anticholinergic
drug (LAMA) tiotropium salt, and the efficient synergistic effect of the two drugs is achieved by optimizing a
drug micronization process, a carrier particle design, a
carrier material and a preparation process. The
medicine can penetrate into a
lung target region, so that precise treatment is realized. A
powder mist
inhalation device CN219423486U disclosed by Nanchang large
pharmaceutical industry limited company is adopted as a delivery device, and the
lung deposition rate and
delivery efficiency of the
medicine are remarkably improved by controlling the particle size of the
medicine, the particle property of a carrier and the uniformity of the preparation. In addition, the invention further provides a preparation method of the preparation, the preparation method comprises the processes of medicine
micronization, mixing homogenization and packaging, and the stability and dosage accuracy of the preparation are ensured. Experiments show that in an accelerated stability investigation period as long as 6 months, the
drug content,
impurity level and fine
particle fraction in the preparation are kept stable and do not change significantly, and it is proved that the preparation has good physical and
chemical stability and storage performance. The preparation has quick-acting and long-acting bronchiectasia effects, is suitable for long-term management of moderate and
severe asthma and chronic obstructive
pulmonary disease (
COPD), and can significantly improve the medication convenience and
treatment compliance of patients.