洛伐他汀缓释片体外药物释放度测定方法的研究Study on Release Determination Method of Lovastatin Sustained-release Tablets in Vitro
李红侠,杨铁耀,刘维刚,李美芳,王铁杰,潘卫三
LI Hongxia~1,YANG Tieyao~2,LIU Weigang~2,WANG Tiejie~3 PAN Weisan~4(1.Meilin Hospital,Futian District,Shenzhen Guangdong 518049
摘要(Abstract):
目的建立简便、准确的测定洛伐他汀缓释片体外药物释放度方法并对其体外释放度进行研究。方法以含0.2%十二烷基硫酸钠的磷酸盐缓冲液(pH7.0)为溶剂,桨法、转速为50 r.m in-1,HPLC与UV对比测定洛伐他汀缓释片释放度。结果采用UV和HPLC 2种方法对比测定同一批样品,结果表明2种方法具有很好的相关性。测定结果经t化极差q法多重比较,证明2种方法之间无明显差异。结论UV可用于洛伐他汀缓释片的质量控制和释放度研究。
Objective To establish a method for the determination of drug release of lovastatin sustained-release tablets in Vitro.Method The releasing midia was 0.2% sodium dodecylsulfate in pH7.0 NaH_2PO_4 buffer.HPLC and UV were applied in this experiment.Results The release rates of lovastatin from lovastatin sustained-release tablets were constant.The UV method was simple,accurate,and had a good correlation with HPLC,and there was insignificent difference between two methods.Conclusion The UV method can be used in the quality control of lovastatin sustained-release tablets.
关键词(KeyWords):
洛伐他汀缓释片;释放度;HPLC;UV
lovastatin sustained-release tablets;drug release in vitro;HPLC;UV
基金项目(Foundation):
作者(Author):
李红侠,杨铁耀,刘维刚,李美芳,王铁杰,潘卫三
LI Hongxia~1,YANG Tieyao~2,LIU Weigang~2,WANG Tiejie~3 PAN Weisan~4(1.Meilin Hospital,Futian District,Shenzhen Guangdong 518049
- 李红侠
- 杨铁耀
- 刘维刚
- 李美芳
- 王铁杰
- 潘卫三
LI Hongxia~1 - YANG Tieyao~2
- LIU Weigang~2
- WANG Tiejie~3 PAN Weisan~4(1.Meilin Hospital
- Futian District
- Shenzhen Guangdong 518049
- 李红侠
- 杨铁耀
- 刘维刚
- 李美芳
- 王铁杰
- 潘卫三
LI Hongxia~1 - YANG Tieyao~2
- LIU Weigang~2
- WANG Tiejie~3 PAN Weisan~4(1.Meilin Hospital
- Futian District
- Shenzhen Guangdong 518049