中国药典2010年版卡托普利片溶出度检验方法研究

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。

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

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.