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Study on the Preparation and Quality Research of Sertaconazole Nitrate Gel

Author: LiCaiWen
Tutor: ChenBaoQuan
School: Tianjin University of Technology
Course: Medicinal Chemistry
Keywords: Nitrate Sertaconazole Gels Quality Research
CLC: R94
Type: Master's thesis
Year: 2010
Downloads: 64
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Abstract

Nitrate Sertaconazole (sertaconazole nitrate) is a new generation of topical anti-fungal treatment drug, the first time in 1992, the trade name Dermofix in Spain listed 2003, China approved the listing of its ointment preparations, the trade name \no gel formulations listed reported. Better play to the convenience of the patient's medication efficacy, this topic nitrate Sertaconazole gel trial, and the formulation and preparation, assay method stability, in order for the preparation of further development has laid the foundation. HPLC method established vitro nitrate Sertaconazole sample conditions column: stainless steel 0.25 m x 4.6mm; mobile phase: acetonitrile - sodium dihydrogen phosphate (37:63); detection wavelength: 302nm; flow rate: 1.6 ml / min; Injection volume: 20μL. The experimental results show that: the law matrix samples without interference, a good linear relationship between concentration and peak area, to meet the analytical requirements. Transdermal drug diffusion tester of this study to examine the different types of carbomer itraconazole gel in vitro release of nitric homes, and thus nitrate homes itraconazole gel matrix screening. The results show that the matrix nitrate Sertaconazole gel in vitro release best Carbomer -940. The gel matrix screening in this paper, its production to provide a reference. This subject on the basis of single factor, multi-factor orthogonal design test screening of the prescription, according to the experimental results to determine the best prescription through the preparation process optimization, nitrate Sertaconazole gel was prepared by HPLC measured The nitrate Sertaconazole content. Stability experiments investigated nitrate stability Sertaconazole gel. The results show that the uniformity of the pharmaceutical preparation, good dispersion; in light, heat and centrifugation conditions, Formulation no deposition, combined, layered, and no significant change in the drug content, meet the requirements of the Pharmacopoeia of the People's Republic of China, and the preparation process of the formulation viable and stable nature of the determination method is simple and accurate. The tested nitrate homes itraconazole gel in vitro permeation and in vitro release and transdermal penetration size comparison by cumulative permeation amount was measured within 24h with nitrate Sertaconazole ointment, results showed that: nitric Sertaconazole gel vitro The permeation rate was zero-order process, the transdermal rate greater than nitrate Sertaconazole ointment, different matrix formulations prepared transdermal penetration ability will be affected to some degree. The irritant experimental, the nitrate homes he itraconazole gel the obvious irritant and allergic adverse reaction does not appear in the course of medication. In vitro the antibacterial experiments and in vitro and in vivo pharmacodynamic still at.

Study on the Preparation and Quality Research of Sertaconazole Nitrate Gel

Abstract

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