本文選題：雙氯芬酸鈉緩釋膠囊　切入點：質量分析　出處：《中國藥房》2017年04期

【摘要】：目的:考察2014年山東省評價性抽驗雙氯芬酸鈉緩釋膠囊的質量現(xiàn)狀,為提高產品質量的均一性和穩(wěn)定性提供參考。方法:采用法定檢驗方法對7廠家(A、B、C、D、E、F、G)51批雙氯芬酸鈉緩釋膠囊的性狀、鑒別、裝量差異、釋放度、有關物質和含量測定等進行全項檢驗,并對檢驗結果進行統(tǒng)計分析;采用文獻方法對膠囊殼中鉻的含量及在不同p H溶出介質中主藥釋放曲線進行探索性研究(以A廠樣品為參比計算相似因子f_2比較差異)。結果:檢品按照質量標準檢驗所有項目均合格,但是各廠家樣品質量有差異,如主藥含量范圍為92.4%~102.1%;探索性研究中鉻含量均低于限度要求,但各廠家間樣品含量及同廠家不同批間樣品含量差異均較大;與A廠家樣品比較,B~G廠家樣品的f_2為37~86。結論:雙氯芬酸鈉緩釋膠囊總體質量較好,但仍需進一步加強質量研究和控制,建議提高釋放度的檢查方法提高標準。
[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.
【作者單位】： 淄博市食品藥品檢驗檢測中心;
【分類號】：R927.2

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本文編號：1659833