青霉胺片溶出度测定方法的建立及质量评价

Establishment of dissolution determination method of Penicillamine tablets and its quality evalution

目的建立青霉胺片溶出度的测定方法,评价国产和国外产制剂的溶出曲线的相似性。方法建立有区分力的溶出度测定方法,分别考察国产和国外产制剂在4种介质中的溶出情况。结果在4种介质中,青霉胺片和国外产制剂的溶出曲线均不相似。结论所用方法适用于青霉胺片的溶出度的测定,并为青霉胺片的一致性评价提供参考。

OBJECTIVE To establish a new method for the dissolution determination of Penicillamine tablets,and to evaluate the comparability of dissolution curves of Penicillamine tablets at home and abroad.METHODS A distinguishing method for dissolution curve tests was established,and the dissolution behaviors of Penicillamine tablets at home and abroad were detected under 4 chosen conditions.RESULTS The dissolution curve of Penicillamine tablets at home showed differences from tablets abroad in 4 chosen conditions.CONCLUSION The method is suitable for the dissolution determination of Penicillamine tablets,making a reference for further quality consistency evaluation.