赖诺普利迟释型缓释片体外释放度的测定

Determination of in vitro release rate for Lisinopril Delayed-Onset Sustained Release Tablet

目的建立紫外分光光度法测定赖诺普利迟释型缓释片体外释放度的方法。方法以纯化水为释放介质,采用桨法,转速为50 r/min,定时取样,用紫外分光光度法测定释放介质中药物含量,检测波长为215 nm。结果赖诺普利在7.442～33.489μg/mL范围内线性关系良好(r=0.999 7),平均回收率为99.78%,相对标准偏差为0.50%。自制片剂在4 h累积释放度小于10.00%,18 h累积释放度达70.25%。结论建立的紫外分光光度法简便、稳定、快速,可用于赖诺普利迟释型缓释片体外释放度的测定。

Objective To establish a UV spectrophotometry method for determining the release rate in vitro of Lisinopril Delayed-Onset Sustained Release Tablet.Methods The paddle method was used with purified water as the dissolve medium,the rotation rate of 50 r/min and timing sampling.The drug content in the dissolve medium was determined by UV spectrophotometry method and the detection wavelength was 215 nm.Results The standard curve of Lisinopril was linear（r=0.999 7） in the range of 7.442-33.489 μg/mL.The average recovery rate was 99.78% with RSD 0.50%.The cumulative release rate of the self-made tablet in 4 h was less than 10.00%,and which in 18 h reached 70.25%.Conclusion This method is simple,stable,rapid,and can be used for determing the in vitro release rate of Lisinopril Delayed-Onset Sustained Release Tablet.