洛伐他汀烟酸缓释片的释放度研究

Drug release in the sustain-realease tablets of niacin and lovastatin

目的 比较自制洛伐他汀烟酸缓释片与国外制剂ALTOCOR的药物释放情况。方法 转篮法。首先以0 .5 %十二烷基硫酸钠的磷酸二氢钠溶液(pH7.0 ) 90 0mL为介质,4 5min后更换溶出介质为水90 0mL。洛伐他汀采用高效液相法测定,烟酸采用紫外分光光度法测定。结果 自制片和国外制剂ALTOCOR中洛伐他汀在4 5min内的溶出度均大于75 % ,烟酸的释放曲线均符合Higuchi方程,其相关系数分别为0 .996 8和0 .996 9。结论 自制片与国外制剂ALTOCOR中烟酸的释放曲线相似因子f2 值为99.95 ,非常相似。

Objective To compare the release of the sustain-realease tablets of Niacin and lovastatin between our products and ALTOCOR.Methods Basket method was used. A mixture of 900 mL of sodium phosphate and 0.5% sodium dodecyl sulfate(pH7.0)was used as the dissolusion medium. After 45 minutes, the dissolusion medium was replaced by 900mL deionized water at once.Lovastatin was determined by HPLC and niacin by UV. Results The release rate of lovastatin was up to 75% in 45 minutes,the release curves of the two products can accord with Higuchi equation(r 1=0.996 8, r 2=0.996 9). Conclusion: The similarity factor (f 2) of the release curves of niacin in the two products is 99.95.