Fudosteine inhalation solution preparation as well as preparation method and application thereof

Abstract

The invention provides a fudosteine inhalation solution preparation as well as a preparation method and application thereof, and belongs to the field of pharmaceutical preparations. The concentration of the fudosteine in the solution preparation for inhalation is 25 to 300 mg / ml. The fudosteine inhalation solution preparation disclosed by the invention is an aerosol inhalation solution, contains fudosteine with a specific concentration, is excellent in aerosol generation property, and can be effectively deposited at a drug effect part of a respiratory tract to achieve a superior drug concentration; the fudosteine aerosol inhalation preparation solves the problem that the fudosteine aerosol inhalation preparation in the prior art does not achieve the optimal inhalation treatment effect, and the drug effect is more excellent. Meanwhile, compared with oral administration, the fudosteine inhalation solution preparation has higher drug distribution in the respiratory system under the same dosage, the phlegm eliminating drug effect is better, the system exposure is lower, the safety is better, and the fudosteine inhalation solution preparation has a good application prospect.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a solution preparation for inhalation of fodosteine ​​and a preparation method and application thereof. Background technique [0002] Respiratory system disease is one of the diseases people are familiar with. Respiratory system disease accounts for about 1 / 4 of medical patients, which brings mental and physical pain to patients. In my country's population statistics, respiratory system disease is the second cause of death. , but there are not many clinically available drugs, and the onset of action is slow. [0003] Sputum is a common symptom of respiratory diseases, and the increase of sputum can stimulate the mucous membrane of the respiratory tract and cause cough. When the sputum blocks the bronchioles, it can not only cause asthma, but also cause secondary infection, further damage the respiratory tract, aggravate cough, expectoration and asthma, and in severe cas...

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Problems solved by technology

[0007] Patent CN108078964A discloses a fudosteine ​​dry powder inhaler. The dose of the inhaler is significantly lower than that of the oral solid preparation, and the therapeutic effect is high and the onset of effect is fast; Some problems such as technicality, inconvenient administration for patients, uneven inhalation dose of multiple administrations, high production cost of special equipment, etc.

Patent CN109925300A discloses a solution preparation of fudosteine ​​for atomized inhalation and its preparation method. Compared with oral preparations, the solution preparation of fudosteine ​​for atomized inhalation has high efficiency, low toxicity, good stability and high safety. However, the aerosol generation characteristics of this inhaler are not clear, and the aerosol drug concentration and particle size distribution have not been studied, and the single dose of its preparation cannot achieve the best inhalation therapeutic effect. At the same time, the patent uses complexing agents, pH regulators make the prescription too complicated, the drug loading of the preparation is low, and the safety hazard is relatively high

[0008] It can be seen that the solid particles inhaled by the dry powder of fudosteine ​​inhalation preparations in the prior art are irritating to the respiratory tract, the use has certain skills, it is inconvenient for patients to administer, and the inhalation dose of multiple administrations is uneven, and the production cost of special equipment Expensive, the treatment effect of nebulized inhalation preparations still needs to be improved, and there is an urgent need for a new fudosteine ​​inhalation preparation

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