| 引用本文: | 刘明洁,许竹梅,陈德俊.中国药典2010年版卡托普利片溶出度检验方法研究[J].中国现代应用药学,2014,31(4):460-462. |
| LIU Mingjie,XU Zhumei,CHEN Dejun.Study on the Dissolution Test of Captopril Tablets in Chinese Pharmacopoeia 2010[J].Chin J Mod Appl Pharm(中国现代应用药学),2014,31(4):460-462. |
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| 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。 |
| 关键词: 卡托普利片 溶出度 |
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| Study on the Dissolution Test of Captopril Tablets in Chinese Pharmacopoeia 2010 |
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LIU Mingjie, XU Zhumei, CHEN Dejun
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Shandong Provincial Institute for Food and Drug Control, Jinan 250101, China
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| 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. |
| Key words: captopril tablets dissolution |
