| Diaper dermatitis (diaper dermatitis), also known as diaper rash, baby hip dermatitis, is not due to change diapers often, and urine bacterial decomposition of ammonia to be produced, resulting in a greater amount of ammonia stimulation of the skin caused by dermatitis. More common in infants. Pathogenesis of neonatal diaper dermatitis include two types:primary irritant diaper dermatitis and Candida diaper dermatitis. At this stage of miconazole nitrate cream mostly domestic and Nappy cream used to treat joint neonatal diaper dermatitis complicated by candidiasis (DDCC), but the main target for the treatment of adult miconazole nitrate cream main ingredients (2%) is too large for newborn, poor tolerance. Both drugs now prepared a new compound, can effectively improve the safety of the drug, increasing the convenience of patients.The topics to miconazole nitrate and zinc oxide as a model drug for the white petrolatum ointment bases, to the antioxidant BHT was prepared containing 0.25% miconazole nitrate and 15% zinc oxide ointment preparation, and its conducted the following studies: In the prescription process of the first stage, the preparation prepared according to indications ointment. Then appropriate viscosity, good stability as the main principle, select white petrolatum ointment as a substrate, and miconazole nitrate and zinc oxide according to the physical and chemical properties, select the appropriate solvent, antioxidants and other functional accessories. Preparation of the compound miconazole nitrate ointment in the physical appearance of zinc oxide, pH, viscosity and stimulating' the study, the results are in line with the requirements of ointment preparations.Part of the quality standard, according to the quality requirements of ointment preparations and model the characteristics of pharmaceutical bulk drugs, the establishment of character, identification, size, quantity of contents, microbial limits, and determination of related substances such as quality control indicators. To ensure safe and effective drugs, we also conducted a check of the methodology antioxidant content validation study, the inspection method to determine the BHT, easy to experiment in the future stability of its investigation.Finally, the subject of the prepared zinc oxide compound miconazole nitrate ointment initial stability, the use of accelerated testing and evaluation of long-term stability test the stability of pharmaceutical preparations and pharmaceutical preparations of the forecast period:sunscreen, sealed, at room temperature (20-25℃) can be stored under the conditions of 2 years. |
