摘要
目的通过考察国内不同药品生产企业洛伐他汀片的溶出情况评价药品质量。方法溶出方法采用桨法,以1.0%十二烷基硫酸钠的磷酸盐溶液900mL为溶出介质,转速为50r.min-1。采用f2因子法,考察国内8家公司的洛伐他汀片与参比公司的洛伐他汀片溶出度的差异。结果 3个公司的洛伐他汀片f2值大于50,溶出度与参比公司制剂相似。其他5个公司的洛伐他汀片f2值小于50,溶出度与参比公司制剂存在明显差异。结论不同公司的洛伐他汀片溶出度有显著差异,仿制药品的质量有待提高。
Objective To evaluate the quality of Lovastatin Tablets by determining the dissolution of Lovastatin Tablets from different manufacturers.Methods The dissolution tests were proceeded using paddle method at 50r·min-1,using 1.0%SDS-phosphate solution 900mL as medium.The difference of dissolution rate was evaluated by f2 factor method.Results The f2 factors of Lovastatin Tablets produced by three factories were over 50.The drug release behaviour was similar to that of the reference preparation.The f2 factors of the other five factories were below 50.The drug release behaviour has significant difference to that of the reference preparation.Conclusion There are significantly different among the quality of the Lovastatin Tablets from different manufacturers.The quality of generic drug need to be improved furthermore.
出处
《中国药事》
CAS
2010年第10期1010-1012,共3页
Chinese Pharmaceutical Affairs
关键词
洛伐他汀片
溶出度
相似因子
Lovastatin Tablets
dissolution
similar factor
