Ear drops for treating otomycosis externa and preparation method of ear drops

Abstract

The invention discloses ear drops for treating otomycosis externa and a preparation method of the ear drops. The ear drops for treating otomycosis externa comprise components in percentage by mass asfollows: 3%-20% of itraconazole, 2%-10% of clotrimazole, 0.8%-2.3% of Carbomer-940, 5%-15% of glycerin, 0.5%-1.5% of triethanolamine and the balance purified water. The preparation method comprises steps as follows: glycerin and Carbomer-940 are dissolved by the purified water, triethanolamine is added during stirring, transparent gel is obtained after the components are stirred uniformly, itraconazole and clotrimazole are added to the transparent gel to be stirred, the purified water is added until the overall mass fraction is 100%, all the components are stirred uniformly, and the ear dropsare obtained. The ear drops have the advantages of being good in antibacterial effect, high in cure rate, convenient and simple to administrate and capable of realizing uniform spraying, producing little stimulation to ears, being easy to store and the like, the preparation method is simple and convenient, and the cost is low.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations and preparation thereof, and relates to an ear drop for treating ear canal fungus and a preparation method thereof, in particular to an ear drop of itraconazole combined with clotrimazole for treating ear canal fungus and its preparation method. Background technique [0002] Ear canal mycosis, as the name suggests, is a fungal infection caused by the growth and reproduction of fungi that should not grow in the ear canal. It is mainly infected by yeast, candida, blastomyces, aspergillus and other bacteria. Once the disease occurs, the ear will itch, which may be accompanied by ear pain. Some patients with fungal ear canal disease will itch more severely at night. At this time, if you repeatedly scratch with your hands, it is easy to scratch the skin of the external auditory canal, causing bleeding and secondary infection. Pus, etc. Severe cases can even cause dizziness, facial paralysis...

AI Technical Summary

Problems solved by technology

[0005] (1) After thorough debridement of the ear, use boric acid alcohol, salicylic acid alcohol, compound resorcinol solution and other antifungal solutions for ear drops. This method is simple to operate, but these drugs will cause burning and irritation after use. Pain and other reactions seriously affect the patient's treatment compliance, and it is difficult to guarantee the thoroughness of the treatment. Moreover, this kind of liquid medicine has the disadvantages of difficult preparation and unsatisfactory storage.

[0006] (2) Use clotrimazole ointment, dacryline cream and other azole ointments for coating, which has the advantage of mild drug properties and will not cause adverse reactions, but its overall curative effect is poor, which is difficult to be accepted by patients, and often due to external auditory canal Physiologically curved and narrow, it is difficult for patients to apply the drug evenly to various parts of the disease

[0007] (3) Use antifungal drugs such as fluconazole injection ear bath for treatment. The medicine solution lasts in the external auditory canal for a long time, and the medicine solution soaks the entire external auditory canal. The treatment effect is better than the above two methods, but it is irritating and cannot Ensure stable clinical effect

[0008] There are many types of antifungal drugs on the market, mainly azoles and most of them are taken orally. Ear drops preparations are a good choice for the treatment of ear canal fungi. Although ear drops preparations containing itraconazole or voriconazole have been reported , but the application is not common, the main reason is that the prescription of the preparation is not mature enough, and the safety and effectiveness have yet to be proved by research

Therefore, in order to solve the many inconveniences of the current treatment methods and the shortcomings of the therapeutic effect, it is urgent to develop a new type of ear canal fungal preparation

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