辛伐他汀的药代动力学特征及不良反应分析

Analysis on Pharmacokinetic Characteristics and Adverse Reactions of Simvastatin

目的:探讨辛伐他汀的药代动力学特征及不良反应。方法 :选取24名健康志愿者作为研究对象,按随机数字表法分为两组,各12例。A组口服辛伐他汀受试制剂(40 mg),B组口服辛伐他汀参比制剂(40 mg),给药后采用液相色谱-质谱联用法(HPLC-MS/MS)测定血药浓度,分析并比较两组药代动力学、生物等效性及不良反应情况。结果 :两组主要药代动力学参数比较,差异无统计学意义(P>0.05);A组生物利用度为(98.80±1.54)%,B组为(97.91±2.31)%,组间比较无统计学差异(P>0.05);两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论 :辛伐他汀经口服给药吸收良好,具有较高的生物利用度,安全性好。

Objective: To explore the pharmacokinetic characteristics and adverse reactions of simvastatin. Methods: 24 healthy volunteers were selected as subjects investigated and randomly divided into group A and group B, 12 cases in each group. The volunteers in group A were given oral simvastatin test preparation(40 mg), and the volunteers in group B were given oral simvastatin reference preparation(40 mg). After administration, blood concentration was determined by high performance liquid chromatography tandem mass spectrometry(HPLCMS/MS), and the pharmacokinetics, bioequivalence and adverse reactions in the two groups were analyzed and compared. Results: There was no significant difference in main pharmacokinetic parameters between the two groups(P>0.05). The bioavailability in the group A was(98.80±1.54)%, and that in the group B was(97.91±2.31)%, so there was no statistical difference between the two groups(P>0.05). There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05). Conclusion: Simvastatin is well absorbed by oral administration, and has high bioavailability and good safety.