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7厂家51批双氯芬酸钠缓释胶囊的质量分析
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| 篇名： | 7厂家51批双氯芬酸钠缓释胶囊的质量分析 |
| TITLE： | |
| 摘要： | 目的：考察2014年山东省评价性抽验双氯芬酸钠缓释胶囊的质量现状，为提高产品质量的均一性和稳定性提供参考。方法：采用法定检验方法对7厂家（A、B、C、D、E、F、G）51批双氯芬酸钠缓释胶囊的性状、鉴别、装量差异、释放度、有关物质和含量测定等进行全项检验，并对检验结果进行统计分析；采用文献方法对胶囊壳中铬的含量及在不同pH溶出介质中主药释放曲线进行探索性研究（以A厂样品为参比计算相似因子f2比较差异）。结果：检品按照质量标准检验所有项目均合格，但是各厂家样品质量有差异，如主药含量范围为92.4％～102.1％；探索性研究中铬含量均低于限度要求，但各厂家间样品含量及同厂家不同批间样品含量差异均较大；与A厂家样品比较，B～G厂家样品的 f2为37～86。结论：双氯芬酸钠缓释胶囊总体质量较好，但仍需进一步加强质量研究和控制，建议提高释放度的检查方法提高标准。 |
| ABSTRACT： | OBJECTIVE： To investigate the quality of Diclofenac sodium sustained-release capsules testing in Shandong province 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 batches. Compared with the sample from A manufacture， the f2 from B，C，D，E，F，G manufactures ranged 37-86. CONCLUSIONS： Diclofenac 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. |
| 期刊： | 2017年第28卷第4期 |
| 作者： | 安佰平，柴龙龙 |
| AUTHORS： | AN Baiping，CHAI Longlong |
| 关键字： | 双氯芬酸钠缓释胶囊；质量分析；铬含量；释放曲线 |
| KEYWORDS： | Diclofenac sodium sustained-release capsules； Quality analysis； Chromium content； Release curve |
| 阅读数： | 784 次 |
| 本月下载数： | 4 次 |
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