摘要
目的制备复方曲安奈德涂膜剂并建立其质量控制方法。方法以壳聚糖为成膜材料制备复方曲安奈德涂膜剂,采用高效液相色谱法测定曲安奈德含量,采用容量法测定谷氨酸锌含量。结果曲安奈德的质量浓度在5.0～80.0μg/mL范围内与峰面积线性关系良好,平均回收率为99.93%,RSD为0.14%(n=9)。结论该制剂制备工艺合理、简单,质量控制方法可行,制剂质量稳定。
Objective To study the method of preparation and quality control of Compound Triamcinolone Acetonide Plastics.Methods To prepare Compound Triamcinolone Acetonide Plastics with chitosan as the membrane material,and to measure the content of triamcinolone acetonide directly by HPLC and the content of glutamic acid zinc directly by volumetric method.Results The linear range of triamcinolone acetonide was 5.0-80.0 μg/mL,its average recovery rate was 99.93%,RSD was 0.14%（n=9）.Conclusion This method is reasonable and simple.The quality control method is feasible with the stable quality of products.
出处
《中国药业》
CAS
2010年第9期39-40,共2页
China Pharmaceuticals
关键词
曲安奈德
谷氨酸锌
壳聚糖
涂膜剂
质量控制
triamcinolone acetonide
glutamic acid zinc
chitosan
plastics
quality control
