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

作　　者：安佰平[1,2] 柴龙龙 柳玉英[2] 

机构地区：[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

出　　处：《中国药业》2016年第13期34-36,共3页China Pharmaceuticals

摘　　要：目的比较国内主要生产厂家生产的双氯芬酸钠缓释胶囊样品在4种溶剂中的释放曲线,为科学评价药品质量提供依据。方法分别以水、0.1 mo L/L盐酸溶液、p H=5.0磷酸盐缓冲溶液、p H=6.8磷酸盐缓冲溶液各900 m L为释放介质,采用转篮法,转速为100 r/min,高效液相色谱法于276 nm波长处测定释放度及释放曲线,通过相似因子法评价溶出曲线的相似性。结果采用相似因子法评价,各厂家受试制剂之间释放曲线差异较大。结论相似因子评价法能够有效反映和控制产品的内在质量,指导厂家改进生产工艺,提高产品质量并为用药者选购药物提供参考。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 

分 类 号：R927.11[医药卫生—药学] R971.1