Study On The Preparation And Quality Research Of Sertaconazole Nitrate Gel

Sertaconazole nitrate, as an antifungal agent, was marketed in Spain with 2% vagainal cream, powder, solution, ointment, vaginal suppository.At present there is no clinical application of gel products, Sertaconazole nitrate gels were prepared for the convenience of medication in patients, and the prescription and preparation process, the content determination, stability determination, have been studied with a view to the preparation lay the foundation for further development.A high performance liquid chromatography method was developed to determine the sertaconazole nitrate. The conditions was as follows:Hypersil column ODSC18(0.20m×4.6mm),UV detective wavelength 220nm. Flow rate 1.6ml/min, mobile phase is composed of Acetonitrile-sodium dihydrogen phosphate (37:63). By which the impurity may be avoided and there is a good linear relationship between and peak area and concentration.To observe the effects of different types of carbomers of percutaneous permeability of sertaconazole nitrate gels in vitro and to optimize the formulation of sertaconazole nitrate gels. The results showed that with Carbopol 940 as a substrate of sertaconazole nitrate gel in vitro release of its best. This filter gel matrix can provide a reference basis for their production.The permeability test in vitro was carried out by using Franz diffusion cell with rats ex vivo skin as barrier.The permeability of s gels was the best when the carbomer-940 used as its base material with its ex vivo permeability coefficient. The optimized gele base material can act as bases for the production of sertaconazole nitrate gels. By the single factors and orthogonal design esperiment, the optimal formulation of sertaconazole nitrate gels was acquired. The sertaconazole nitrate gels were prepared and the content were determined with HPLC method. The preliminary stability experiments were carried out and the result showed that no flocculation, coalescence or breaking was not obviously changed. The preparation process is simple and quality controllable. Physical and chemistry properties of the sertaconazole nitrate gel are stable.The sertaconazole nitrate gels gel can be prepared feasibly and is stable. The method for content determination is simple and accurate.To study the release and the percutaneous permeation of gels, the permeation and release of sertaconazole nitrate gels were compared with sertaconazole nitrate ointment within 24h. The results showed that sertaconazole nitrate in transdermal gel was permeated at zero rate and indicated the transdermal penetration capacity of the prepared dosage form using different base will be affected to some degree.The results of rabbits-skin test showed that the sertaconazole nitrate gel had no irritation. The pharmaco-dynamids of sertaconazole nitrate gel.