不同厂家辛伐他汀口服制剂溶出度比较

The Comparation of Dissolution Degree of Different Oral Simvastatin Products

目的考察国内不同厂家辛伐他汀口服制剂的体外溶出度情况,并同默沙东公司产品进行比较。方法色谱柱为WaterssymmetryC18柱,流动相为乙腈-pH值为4.5的0.025mol/L磷酸二氢钠(65∶35),流速为1.6mL/min,检测波长为238nm,测定不同厂家的9个品种的体外溶出度,采用SPSS对各组之间溶出度值的方差齐性进行检查。结果辛伐他汀浓度线性范围是1.592～25.47μg/mL(r=0.9999),平均加样回收率为99.8%(RSD=0.68%),各个品种的溶出度都大于80%,但各组溶出度方差差异较大。结论不同厂家辛伐他汀口服制剂溶出度都符合要求,但溶出度均一性差异较大,舒降之各样品之间的体外溶出度差异最小。

Objective To invesligate the dissolution in vitro of different oral Simvastalin prodducts of China and compare with the products of Merck Sharp Dohme Pharmaceutical Co.,Ltd. （MSD）. Methods Chromatogram column of Waters Symmetry C18, and mobile of acetomilrile （0. 025 tool/L） -sodium dihydrogen phosphate （pH =4.5.65：35） were performed, At flow speed of 1, 6 mL/min and in wavelength 238 nm, we detecled the dissolution degree of 9 Simvastation produels of diferent pharnlaceutical factories, And analyzed them with SPSS for variance. Results Simvastatin had linear better in the range between 1.592-25.47 μg/mL （r=0.9999）,The rectver rate was 99.8% （RSD=0.68% ）. Every dissolution degree of all pn,ducts was over 80% with significant difference amng them. Conclusion The dissolution degree of 9 products reached the standard but Ihe dissolution tmiformily was different significantly. The dissolution degree of statins in givo was little different.