Tiotropium bromide powder inhalation and preparation method thereof

Abstract

The invention discloses a tiotropium bromide powder inhalation, which is obtained by carrying out micro powder treatment on a tiotropium bromide raw material, separating the raw material with the grain size in a range of 1-5 microns through a multistage cascade impactor NGI, mixing with inhalable lactose, and encapsulating. The grain size of the tiotropium bromide raw material of the tiotropium bromide powder inhalation provided by the invention is in the range of 1-5 microns, so that the security and the effectiveness in drug use can be improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a tiotropium bromide powder spray and a preparation method thereof. Background technique [0002] Chronic obstructive pulmonary disease is a common, chronic and progressive respiratory disease characterized by chronic bronchitis or emphysema, which often causes severe deterioration of lung function, eventually leading to disability and death, and seriously endangers human health , is the fourth cause of death in the world, second only to heart disease, cerebrovascular and acute lung infection. [0003] Tiotropium bromide is a new generation of anticholinergic drugs, he is the first once-daily inhalation can selectively act on M 1 , M 3 Receptors can dilate the bronchi of COPD patients for up to 24 hours, effectively exert the therapeutic effect of drugs, and significantly and persistently improve lung function and symptoms of respiratory difficul...

AI Technical Summary

Problems solved by technology

However, none of the above prior art mentions how to control the particle size range after micronization of tiotropium bromide, only the upper limit of the particle size is controlled, which makes it difficult to ensure the uniformity of the effective inhalation dose of the drug

Although there is a powder separator that can collect raw materials with different particle sizes separately, it still cannot be completely separated

In dry powder inhalation, if the particle size cannot be effectively controlled, it will cause differences in curative effect, and even lead to ineffective preparations.

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