圣肤霜中地塞米松稳定性的影响因素及处方工艺优化.pdfVIP

中国药物应用与监测 2014 年2 月第11卷第1期 Chinese Journal of Drug Application and Monitoring, Vol.11, No.1, February 2014 圣肤霜中地塞米松稳定性的影响因素及处方工艺优化 赵维娟，张　梅，王金萍（北京军区总医院药理科 ，北京 100700 ） [摘要 ]　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。 [关键词 ]　圣肤霜；地塞米松；影响因素；处方优化 [ 中图分类号]　R927.11 ；R977.1 [ 文献标识码 ]　A　 [ 文章编号 ]　1672 – 8157(2014)01 – 0018 – 03 Study on the factors affecting the stability of dexamethasone in Shengfu frost and the optimization of its formulation ZHAO Wei-juan, ZHANG Mei, WANG Jin-ping(Department of Pharmacology, General Hospital of Beijing Military Command, Beijing 100700, China) [ABSTRACT]　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.