Glucocorticoid aerosol inhalation suspension and preparation method thereof

Abstract

The invention provides a preparation method of a glucocorticoid aerosol inhalation suspension. The method comprises the following steps: (1) preparation of a mixed liquid, namely dispersing glucocorticoid into a water solution, and obtaining a mixed liquid containing a glucocorticoid insoluble medicine; and (2) high-pressure homogenization, namely homogenizing the mixed liquid through a high-pressure homogenizer until the particle size distribution is d(v, 0.5)=1-3 microns, so as to obtain the suspension. The preparation method also can comprise the steps of filling and sterilizing; the finally obtained glucocorticoid aerosol inhalation suspension comprises glucocorticoid and a water solution; the particle size distribution is d(v, 0.5)=1-3 microns; and the components also can comprise medicinal additives including a pH modifier, a suspending agent, a wetting agent and an isoosmotic adjusting agent. By virtue of a high-pressure homogenization crushing method, all defects of an airflow crushing method can be effectively solved; and the obtained product is relatively good in appearance, and is free of instability phenomena such as FPF and FPD reduction.

Description

technical field [0001] The invention relates to a suspension, in particular to a glucocorticoid atomized inhalation suspension and a preparation method thereof. Background technique [0002] Drug atomization inhalation therapy, as a new treatment method, uses high-speed airflow to spray the drug into mist and directly rushes to the small bronchus, terminal bronchi and alveoli, so that the drug can directly contact the lesion, thereby increasing the local drug concentration and playing a role. It can expand the bronchus and reduce inflammation, and can keep the airway moist and dilute sputum to facilitate expectoration. Therefore, it also has important clinical significance for upper respiratory tract infection, trachea and bronchial inflammation, pneumonia, bronchial asthma, and bronchiectasis; Not only that, the study found that the treatment of other diseases also has obvious therapeutic effects through drug aerosol inhalation therapy. [0003] CN104224760A discloses a pr...

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Problems solved by technology

[0006] In order to overcome the deficiencies in the actual application of raw material micronization using airflow pulverization in the existing technology of preparing atomized inhalation suspension, the invention provides a kind of glucocorticoid atomized inhalation suspension and its preparation method, wherein the raw material drug powder The method of high-pressure homogenization and pulverization can effectively solve all the shortcomings of the jet pulverization method, especially the micronization of the raw material to a particle size distribution of d(v,0.5)=1-3um (measured by a Malvern laser particle size analyzer) When the median value of the volume diameter), the appearance of the product obtained by high-pressure homogenization is better, and the atomized inhalation suspension does not have product instability such as FPF and FPD reduction. It can be seen that this method is suitable for the atomization inhalation suspension containing insoluble drugs. liquid preparation, especially for

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