Citrate-sugar alcohol solution used for aerosol inhalation

Abstract

The invention provides an aqueous solution preparation of citrate and sugar alcohol for aerosol inhalation for reducing phlegm. The sugar alcohol is any one selected from the group consisting of mannitol, sorbitol, inositol, galactitol, xylitol, arabitol and erythritol, and has the advantages of greatly reducing the adverse reaction of dry throat and sore throat caused by the citrate and improvingthe administration concentration of the citrate at the same time.

Description

technical field [0001] The invention belongs to the field of pharmacy, in particular, the invention relates to an aqueous solution for nebulized inhalation containing citrate and sugar alcohol. Background technique [0002] Nebulization inhalation treatment is to disperse medicine and water into mist particles or particles suspended in the gas through the inhalation device, and deposit them in the respiratory tract and (or) lungs through inhalation, so as to achieve the effect of local treatment of the respiratory tract. Administration through nebulization inhalation can relieve bronchospasm, dilute sputum, and prevent respiratory tract infection. In many respiratory diseases, such as chronic obstructive pulmonary disease (COPD) in adults, bronchial asthma in children, acute laryngitis, allergic cough and other diseases, aerosol inhalation can be used for treatment. The biggest advantage of aerosol inhalation therapy is that the drug can directly reach the airway or lungs. ...

AI Technical Summary

Problems solved by technology

For the existing aerosol inhalation administration, most of them are converted from injections, and the problems of taste discomfort and oropharyngeal discomfort caused by the physical and chemical characteristics of the drug are rarely considered, and these two problems will cause problems during the medication process. The patient's compliance becomes poor, and after the patient's compliance becomes poor, it will be difficult to cooperate with the atomization unconsciously. For example, a very real problem is that although the patient has the atomization inhalation in his mouth, he will consciously or unconsciously Carry out a very slight inhalation or inhale air through the nose, and the exhaled water vapor enters the atomization cup again, resulting in the atomization inhalation that should have been completed in about 15 minutes, but the atomization still cannot be completed after 45 minutes, the atomization cup There is always a large amount of solution in the atomization cup, and such a process will lead to the waste of medicine and cannot reasonably enter the respiratory tract, causing insufficient dosage, and the medicine will be decomposed in the atomization cup for too long, and the temperature will increase, which will cause the medicine to decompose and cause unnecessary side effects.

[0004] In the process of developing potassium sodium citrate for atomized inhalation, in order to solve the problem of dry throat and stinging caused by potassium sodium citrate, we tried a variety of drugs and excipients, and finally found some sugar substances (such as monosaccharides, oligosaccharides and sugar alcohols) can inhibit the adverse reactions of dry throat and tingling caused by sodium potassium citrate, especially some sugar alcohols have better performance, these sugar alcohols Including mannitol, sorbitol, inositol, galactitol, xylitol, arabitol, maltitol, isomalt, lactitol, ribitol and erythritol, among these sugar alcohols, preferred The sugar alcohols of hexyl alcohol perform better, such as mannitol, sorbitol, and inositol. Search the literature on the use of these sugar alcohols for respiratory tract administration, and find that there are formal documents that mannitol can be used for respiratory tract inhalation administration According to reports, there are also such inhalation dry powder drugs on the market, but it is clearly pointed out in the adverse reactions of this drug that inhalation of mannitol dry powder can cause throat irritation and swelling, and our test on healthy volunteers aerosol inhalation of sugar alcohols The solution verified its irritation to the respiratory tract. It was found that inhalation of 15% mannitol solution for 30 minutes had no irritation to the respiratory tract, and then tested with 40% sorbitol solution for 30 minutes. Surprisingly, it was found that the respiratory tract There is no irritation, so we made a mixed atomized inhalation solution of 20% potassium sodium citrate and 20% sorbitol, and inhaled it for 30 minutes through an atomizer inhaler, which greatly reduced the risk due to potassium sodium citrate. Throat dryness and throat irritation

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