7厂家51批双氯芬酸钠缓释胶囊的质量分析

发布时间：2018-03-24 20:06

本文选题：双氯芬酸钠缓释胶囊　切入点：质量分析　出处：《中国药房》2017年04期

【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p H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f_2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f_2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 status of diclofenac sodium sustained-release capsules in Shandong Province in 2014. In order to improve the homogeneity and stability of the product quality, the characteristics, identification, loading difference and release rate of 51 batches of diclofenac sodium sustained-release capsules from 7 manufacturers were determined by using the method of legal inspection. The related substances and determination of the content of the whole test, and the results of statistical analysis; The contents of chromium in capsule shell and the release curve of main drug in different pH dissolution medium were studied by literature method. The similarity factor f2 was calculated by reference of factory A. Results: according to quality standard, the content of chromium in capsule shell and the release curve of main drug were studied. All items are eligible for inspection, However, the quality of samples from different manufacturers is different, such as the range of main drug content is 92.40.The content of chromium in exploratory research is lower than the limit, but the content of samples and samples in different batches of the same manufacturers are different greatly. Compared with the samples from manufacturer A, the f2 of samples from BHG factory is 370.Conclusion: the overall quality of diclofenac sodium sustained-release capsules is better, but the quality research and control should be further strengthened, and the standard of examination method for increasing release rate should be improved.
【作者单位】：淄博市食品药品检验检测中心;
【分类号】：R927.2

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