Umeclidinium bromide atomization inhalation solution and preparation method thereof

Abstract

The invention discloses an umeclidinium bromide atomization inhalation solution and a preparation method thereof. The umeclidinium bromide atomization inhalation solution per 1,000 ml contains 0.01-0.5 g of umeclidinium bromide, 0.01-0.5 g of a surfactant, 1-100 g of an isoosmotic adjusting agent, 0.1-1 g of a metal ion complexing agent and 0.1-20 g of a pH buffering agent, a pH adjusting agent adjusting the pH of the system to 4.0-7.0 and the balance water, and the total amount is 100 ml. According to the umeclidinium bromide atomization inhalation solution and the preparation method thereof,not only can the potential harm of a lactose carrier in dry powder inhalation be avoided, but also the conveyed dosage is accurate and controllable, the requirement for the breathing air flow is low,and the compliance is good. The preparation method is simple to implement, the required equipment is simple, and the sterility requirement of the product can be met. According to the umeclidinium bromide atomization inhalation solution, the surfactant is added, and therefore side effects generated after the atomization inhalation solution is inhaled by a normal person in the atomization process are reduced, and the utilization rate of the medicine is also increased.

Description

technical field [0001] The invention relates to the field of umeclidinium bromide preparations, in particular to a umeclidinium bromide atomized inhalation solution and a preparation method thereof. Background technique [0002] Chronic obstructive pulmonary disease (COPD) has become a serious public health problem due to its large number of patients, high mortality rate and heavy socioeconomic burden. COPD is currently the fourth leading cause of death in the world, and by 2020 COPD will rank fifth in the world's economic burden of disease. In China, COPD is also an important chronic respiratory disease that seriously endangers people's health. Pulmonary administration can directly deliver drugs to the bronchi and lungs. While improving the therapeutic effect, it can greatly reduce the dose of oral administration and reduce the side effects of drugs. Therefore, pulmonary administration is the preferred route of administration for COPD treatment. [0003] The treatment dru...

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Problems solved by technology

[0008] The technologies disclosed in the above-mentioned patents are all powder sprays and aerosols, which require the patient to start the synchronization of atomization and inhalation (required for aerosol inhalation) or rely on the patient’s large inspiratory flow rate to start atomization (inhalation of powder). nebulizer required)

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