伊曲康唑胶囊的质量评价

Quality analysis of itraconazole capsules

目的 评价国内不同企业生产的伊曲康唑胶囊的质量。方法 依据现行的质量标准,对抽取到的样品进行检验;根据标准检验结果和专题调研情况,对有关物质、溶出行为、稳定性和水分活度开展了研究。结果 按法定标准检验131批次样品,合格率为100%;对本品杂质谱的分析显示,其杂质水平主要与原料药有关,但不同企业的杂质谱差异不明显;各企业样品的溶出行为由于处方、工艺的不同而存在不同程度的差异,伊曲康唑胶囊内容物小丸的稳定性与其溶出行为存在一定的相关性;且其稳定性及水分活度也存在不同程度的差异。结论 目前国内伊曲康唑胶囊质量情况与2015年相比有明显改善,但质量标准需进一步完善。另外,建议企业对伊曲康唑胶囊的处方工艺进行再评价。

Objective To evaluate the quality of itraconazole capsules from different manufactures.Methods The itraconazole capsules were tested according to the official quality standards. Related substances,dissolution behavior, stability, and water activity were studied based on the inspection results and special investigations. Results 131 batches of itraconazole capsules were inspected according to the legal standard, and the qualified rate was 100%. The main impurities were analyzed, and the level of impurities was determined to be mainly related to the active pharmaceutical ingredient, but the difference of impurity spectrum of different enterprises was not obvious. The dissolution behavior of samples from different enterprises varied with the prescription and process,and there was a certain correlation between the stability of itraconazole capsule content and its dissolution behavior.The exploratory research results showed that the stability and water activity of samples from different enterprises were different. Conclusion At present, the quality of itraconazole capsules was good, which was significantly improved compared with 2015, but the current standard needs to be improved. In addition, it is suggested that the prescription and the manufacturing process should be reevaluated further.