烟酰胺凝胶的制备及质量控制

目的:制备烟酰胺凝胶并建立其质量控制方法。方法:以烟酰胺为主药制备凝胶,采用紫外-可见分光光度法测定烟酰胺的含量。结果:该制剂为无色透明胶体,鉴别、检查项均符合2010年版《中国药典》中的相关规定。烟酰胺检测浓度的线性范围为6.24～16.64μg·mL-(1r=0.999 5),平均回收率为102.0%,RSD=0.33%(n=5)。结论:本制剂制备工艺简单可行,质量稳定可控。

Preparation and Quality Control of Nicotinamide Gel

OBJECTIVE： To prepare Nicotinamide gel and to establish its quality control method.METHODS： Nicotinamide gel was prepared using nicotinamide as main ingredient,and the content of nicotinamide was determined by UV-visible spectrophotometry.RESULTS： Preparation was colorless gel,and its identification and test were all in conformity with the related regulation stated in Chinese Pharmacopoeia（2010 edition）.The linear range of nicotinamide was 6.24～16.64 μg·mL^-1（r=0.999 5） with an average recovery rate of 102.0%（RSD=0.33%,n=5）.CONCLUSION： The preparation procedure is simple and feasible,and the quality of the preparation is stable and controllable.