7厂家辛伐他汀片的溶出度考察

Investigation of Dissolution Rate of Simvastain Tablets from 7 Pharmaceutical Factories

目的:考察不同药厂生产的辛伐他汀片的体外溶出情况,为临床用药提供参考。方法:对7厂家辛伐他汀片分别以水、pH6.8磷酸盐缓冲液、《中国药典》2010版中规定的pH7.0十二烷基硫酸钠/磷酸二氢钠缓冲液为溶出介质,采用桨法,转速为50r·min-1,考察其溶出情况,并以日本"orangebook"中规定的标准溶出曲线为对照,同时进行相似因子f2的比较。结果:各厂家辛伐他汀片在pH7.0十二烷基硫酸钠/磷酸二氢钠缓冲液中均具有良好的溶出性,在15min内的累积溶出度均达到了80%以上;但在水和pH6.8磷酸盐缓冲液中的溶出结果存在较大差异,且f2大多小于50。结论:不同厂家辛伐他汀片在不同溶出介质中溶出差异很大,制剂质量有显著性差异,建议临床用药时加以注意。

OBJECTIVE： To study the in vitro dissolution rate of Simvastain tablets from different pharmaceutical factories, and to provide reference for clinical use of drugs. METHODS： The dissolution rates of Simvastain tablets from 7 pharmaceutical factories were investigated by paddle method at rotating speed of 50 r.min^-1 using water and phosphate buffer solution （pH=6.8）, lauryl sodium sulfate/monosodic alkaline buffer solution （pH=7.0） stipulated in Chinese Pharmacopeia （2010 edition） as dissolution medium with standard dissolution curves stipulated in ＂orange book＂ of Japan as control. The comparison of similar factor f2 was conducted. RESULTS： Simvastain tablets dissolved in lauryl sodium sulfate/monosodic alkaline buffer solution （pH=7.0） well. The accumulative dissolution rate was 80% within 15 min. The dissolution of Simvastain tablets in water and phosphate buffer solution （pH= 6.8） was different, and similar factor fi was almost smaller than 50. CONCLUSIONS： The dissolution of Simvastain tablets from different pharmaceutical factories in different medium is different significantly. There is significant difference among the quality of Simvastain tablets from different pharmaceutical factories, which should be paid attention in clinical application.