糠酸莫米松鼻用即型凝胶剂的稳定性研究

目的研究糠酸莫米松鼻用即型凝胶剂的稳定性。方法参照中国药点2005版附录对本品性状、pH、成凝前后黏度、每喷含量、制剂含量和有关物质等项目的稳定性进行考察。结果在高温、强光影响因素条件下,糠酸莫米松鼻用即型凝胶剂有关物质有增加的趋势,含量和每喷含量略有下降,提示高温与强光对本品的稳定性有影响。加速和长期试验结果显示,本品采用市售包装的稳定性良好。结论本品需选用棕色玻璃瓶,于2^25℃处密闭保存。

Studies on the stability of mometasone furoate in situ gel

Aim To study the stability of mometasone furoate in situ gel. Methods According to the Pharmacopeia Appendices（ China, 2005 ） ,we assessed the property, pH, viscosity of the test gels, content per spray, related substance and content of the product in the study. Results Under the condition of strong light and high temperature, the related substance bad the tendency to increase, and the content moderately decreased, suggesting that strong light and high temperature were the factors to influence the product stability. The product with container showed a good stability in accelerated and long-term study. Conclusion Amber glass bottle should be used to protect the product from light and it should be store at 2 -25℃.