摘要
Abstract
OBJECTIVE:To investigate the quality of Diclofenac sodium sustained-release capsules testing in Shandong prov-ince in 2014,to provide the reference for improving the homogeneity and stability of product quality. METHODS:51 batches of Diclofenac sodium sustained-release capsules from 7 manufacturers(A,B,C,D,E,F,G)were tested by statutory inspection test in respects of property,identification,content uniformity,release rate,related substance,content determination,etc. The inspection results were analyzed statistically. The content of chromium in capsule shell and release curve of diclofenac sodium in dissolution mediums with different pH were explored and tested by literature method (compared by similarity factor f2 with sample from A). RESULTS:All items of samples were in line with the quality standard,but there was difference in the quality of samples among different manufacturers,such as the content ranged 92.4%-102.1%. In exploration test,the content of chromium was lower than the limit requirement,but the content of diclofenac sodium had great difference among different manufacturers and different batch-es. Compared with the sample from A manufacture,the f2 from B,C,D,E,F,G manufactures ranged 37-86. CONCLUSIONS:Di-clofenac sodium sustained-release capsules are superior in quality. But it is still suggested to strengthen quality study and control, and raise the standard for release rate test.关键词
双氯芬酸钠缓释胶囊/质量分析/铬含量/释放曲线Key words
Diclofenac sodium sustained-release capsules/Quality analysis/Chromium content/Release curve分类
医药卫生
