中国药业2016，Vol.25Issue(13)：34-36,3.
不同厂家双氯芬酸钠缓释胶囊释放曲线比较研究
Comparative Studies on Dissolution Profiles of Diclofenac Sodium Sustained Release Capsules from Different Pharmaceutical Manufacturers
安佰平 1柴龙龙 2柳玉英1
作者信息
- 1. 山东省淄博市食品药品检验检测中心，山东 淄博 250086
- 2. 山东理工大学，山东 淄博 250049
- 折叠
摘要
Abstract
Objective To compare the similarity of dissolution curves of Diclofenac Sodium Sustained Release Capsules from major do-mestic drug enterprises in 4 solvents, and provide the basis for a comprehensive evaluation of the quality of Diclofenac Sodium Sus-tained Release Capsules. Methods Water, 0. 1 moL/L hydrochloric acid solution, pH 5. 0 phosphate buffer, pH 6. 8 phosphate buffer 900 mL were used respectively as stripping media. The rotation speed was 100 r/min, and HPLC determination at 276 nm. The similar-ity of Dissolution curve was evaluated by f2 similarity factor method. Results Similarity factor was evaluated, the disslution curves of the same batch of test preparation exhibited obvious differences. Conclusion The similarity factor evaluation method can effectively reflect and control the intrinsic quality of the product, instruct manufacturers to improve production processes and product quality.关键词
双氯芬酸钠缓释胶囊/释放度/释放曲线/相似因子Key words
Diclofenac Sodium Sustained Release Capsules/dissolution/dissolution curve/f2 similarity factor分类
医药卫生引用本文复制引用
安佰平,柴龙龙,柳玉英..不同厂家双氯芬酸钠缓释胶囊释放曲线比较研究[J].中国药业,2016,25(13):34-36,3.
