CAJ | 학술논문

目的：考察圣肤霜中地塞米松的稳定性，剔除影响因素，优化处方工艺。方法：采用分散均匀性和高温破坏实验方法，定量筛查影响地塞米松稳定性的因素，调整处方、改进工艺。结果：基质中pH>7.3时地塞米松含量不稳定，呈明显的下降趋势；地塞米松在极性较强的溶液中溶解性降低，是导致药物分散不均匀的主要因素。以适量氮酮溶解地塞米松，依照工艺制备成乳膏可达到均匀分散的效果。调整处方pH在5.5~6.5之间，地塞米松含量稳定。结论：以加速破坏实验和溶解度考察法综合分析影响药物稳定性的因素，该方法科学合理，适用于处方工艺的快速筛查及优化。
목적：고찰골부상중지새미송적은정성，척제영향인소，우화처방공예。방법：채용분산균균성화고온파배실험방법，정량사사영향지새미송은정성적인소，조정처방、개진공예。결과：기질중pH>7.3시지새미송함량불은정，정명현적하강추세；지새미송재겁성교강적용액중용해성강저，시도치약물분산불균균적주요인소。이괄량담동용해지새미송，의조공예제비성유고가체도균균분산적효과。조정처방pH재5.5~6.5지간，지새미송함량은정。결론：이가속파배실험화용해도고찰법종합분석영향약물은정성적인소，해방법과학합리，괄용우처방공예적쾌속사사급우화。
Objective:To investigate and eliminate the factors affecting the stability of dexamethasone in Shengfu frost, and optimize its formulation. Methods: The dispersible uniformity test and the high temperature destruction test were carried out for quantitative analysis of the factors affecting the stability of dexamethasone, on the basis of which we optimized the formulation and process. Results:The study showed the content of dexamethasone would decrease apparently, when the pH level of the matrix was higher than 7.3. The solubility of dexamethasone was low in highly polar solvents, which was the main factor of heterogeneous dispersion. Dissolving dexamethasone in appropriate amount of laurocapram before the preparation will make the dispersion uniform. The content of dexamethasone could be stable when the pH level of the matrix was between 5.5 and 6.5. Conclusion:The accelerated destruction test and the solubility test were adopted for comprehensively analyzing the factors which affected the formulation stability. The method is reasonable and suitable for the quick investigation and optimization of formulations.