不同厂家氟康唑胶囊在4种溶出介质中的溶出曲线比较研究

目的: 比较6个厂家氟康唑胶囊在4种溶出介质中的溶出曲线,为全面评价药品质量提供依据。 方法: 采用篮法,以4种溶出介质各500 mL 为溶出介质,转速100 r·min^-1,采用高效液相色谱法,测定溶出曲线,并用f₂因子法进行了比较分析。 结果: 在0.1 mol·L^-1盐酸中6个生产厂家氟康唑胶囊制剂的溶出曲线基本一致,在其他3种溶出介质中,仅有1个厂家的溶出曲线均与原研厂家相似。 结论: 仅有少数厂家的溶出曲线在4种介质中与原研厂家相似。建议与原研厂家溶出曲线不一致的相关厂家改进制剂的处方工艺以提高药品质量。

Objective: To compare the dissolution profiles of fluconazole capsules from 6 pharmaceutical manufactures in four dissolution mediums,and provide the basis for a comprehensive evaluation of the quality of fluconazole capsules. Method: Basket method was adopted at 100 r·min^-1,the dissolution profiles were determined with HPLC,and comparatively analyzed by the f₂ factor method. Results: The dissolution profiles of fluconazole capsules of 6 pharmaceutical manufactures in 0.1 mol·L^-1 hydrochloride acid solution were similar to each other,only one are similar to original drug in other 3 dissolution mediums. Conclusion: Only few pharmaceutical manufactures is similar to original drug in all 4 dissolution mediums.It is advised that pharmaceutical manufactures should improve the product quality by changing the formulation and process.

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