The Development Of Amorolfine Hydrochloride Liniment

Onychomycosis is a common nail disease in clinical,accounting for 1/3 of the infectious diseases of dermatomycosis and 50% of the nail diseases.Patients infected with onychomycosis,will have a physiological burden,but also a certain psychological blow.In daily life,pathogens can also cause allergic reactions to patients,or become a source of infection in the population.Therefore,the treatment of onychomycosis is becoming more and more urgent,and has become a key research project.Amorolfine,as a topical drug for onychomycosis,has a significant effect on mild infections and can be widely used to sterilize or inhibit bacteria.At present,various new dosage forms are being continuously studied in clinic to help the drug penetrate into the deck better and reach the treatment site.In addition to single treatment,it can also be combined with other oral drugs,such as itraconazole,terbinafine and so on.Amorolfine has less side effects and better efficacy for superficial fungal infections.At present,amorolfine is also an ideal drug for the treatment of skin fungal diseases,and has broad application prospects in the clinical market.Amorolfine hydrochloride liniment forms a drug delivery system due to its special auxiliary materials,and a layer of film will be formed when applied on the deck.When the solventevaporates,the drug can be left on the deck for a long time and penetrate into the deck,so that the drug can act on the infected site and enhance the action time of the drug.The topics to the main drug amorolfine hydrochloride,eudragit RL100? glycerol triacetate?ethyl acetate?butyl acetate and ethanol were used as the auxiliary materials to develop a liniment.And we carried out the following research:In the first part,the prescription process of amorolfine hydrochloride liniment was studied.According to the special anatomical structure of the deck,liniment is selected as the best dosage form,which is easy to be applied and convenient for sanitation.Preliminary prescriptions were determined according to relevant patent literatures,and then the properties,pH value and relative density were used as screening indicators to select the optimal prescription.In the second part,the quality standard of amorolfine hydrochloride liniment was studied.The items of amorolfine hydrochloride liniment were tested by referring to the quality standard of amorolfine hydrochloride,the dosage form characteristics,the requirements of Chinese pharmacopoeia liniment and so on.In this experiment,the related substances and contents of amorolfine hydrochloride were determined by high performance liquid chromatography(HPLC),and the self-made samples and commercial samples were tested,which provided experimental basis for the quality control of amorolfinehydrochloride liniment.In the third part,the stability test of amorolfine hydrochloride liniment was studied under three conditions of temperature,humidity and light.The investigation of stability has laid a solid foundation for the quality,safety and controllability of drugs.In the last part,the nail penetration test of self-made liniment and market liniment was studied,and the nail penetration rate and the amount of nail penetration were compared,which has reference significance for the absorption and penetration of drugs.The experimental results show that the permeation ability of self-made liniment is similar to that of commercially available liniment,which can be regarded as equivalent in efficacy.