中国药典2010年版卡托普利片溶出度检验方法研究

    Study on the Dissolution Test of Captopril Tablets in Chinese Pharmacopoeia 2010

    • 摘要: 目的 改进卡托普利片溶出度检测方法。方法 采用转篮法测定卡托普利片溶出度,以0.01 mol·L-1盐酸溶液900 mL为溶出介质,转速50 r·min-1,经20 min取样。结果 采用USP对A、B厂的卡托普利片进行溶出度检测,溶出曲线存在明显的差异;B厂产品不符合规定,且批内均一性也存在很大差异。结论 改进的方法极大地抑制了卡托普利的降解,对改进制剂处方工艺及控制产品质量提供了有益的参考,可用于卡托普利片的溶出度检查。

       

      Abstract: OBJECTIVE To improve the dissolution determination method of captopril tablets. METHODS The new established dissolution determination method was the basket method. The 0.01 mol·L-1 hydrochloric acid of 900 mL was used as the dissolution medium, the rotation speed was 50 r·min-1 and the time was 20 minutes. RESULTS According to the USP dissolution test on sample of manufacturer A and B, the difference of dissolution curves was obvious. In addition, the sample of manufacturer B was unqualified and the uniformity of within-lot was bad. CONCLUSION The improved method inhibites the degradation of captopril. It provides a reference for the quality control of captopril tablets, and can be used for the dissolution test of captopril tablets.

       

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