同一厂家两个批号尼莫地平片生物利用度比较

COMPARITION OF BIOAVAILABILITY OF NIMOLDIPINE PRODUCED FROM SAME CHEMIST'S FACTORY IN DIFFERENT PERIOD

目的：了解市售尼莫地平片生物利用度重现性。方法：对１８名志愿者分成两组，一组口服同一厂家批号９６１００２尼莫地平１２０ｍｇ，另一组口服批号９７０７０２尼莫地平１２０ｍｇ，计算药动学参数ｔ１／２（β）、ＡＵＣ、ｔｍ、ｃｍ。结果：药动学参数数据用方差齐性检验，方差齐性的用成组ｔ检验，方差不齐的用ｔ′检验。两批号间除ｔ１／２（β）外，ＡＵＣ、ｔｍ、ｃｍ有显著性差异（Ｐ＜００１）。

OBJECTIVE:To investigate repetition of bioavailability of nimoldipine.METHOD:18 healthy volunteers were divided into two groups.Two groups were given orally 120 mg nimoldipine approval number are 961002 and 970702 respectively.We analyzed their pharmacokinetics by t 1/2(beta),AUC,tm,cm. RESULTS:Statistical analysis showed there was significant difference of ACU,tm,and cm between the two groups( P <0 01),except t 1/2 (beta).CONCLUSION:There is a significant different quality of nimoldipine between different approval numbers.