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首页> 外文期刊>Arzneimittel-Forschung: =Drug Research >Bioequivalence evaluation of two brands of lisinopril tablets by in vitro comparative dissolution test and in vivo bioequivalence test.
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Bioequivalence evaluation of two brands of lisinopril tablets by in vitro comparative dissolution test and in vivo bioequivalence test.

机译：通过体外比较溶出试验和体内生物等效性试验评估两个品牌的赖诺普利片的生物等效性。

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The bioequivalence of a test formulation (Nanopril, "test") and a reference formulation ("reference") of lisinopril (CAS 83915-83-7) was demonstrated by in vivo and in vitro tests. The in vivo bioequivalence study in 26 healthy volunteers was designed as a single dose, randomized, double-blind trial with a 2-week washout period between the doses. Prior to the in vivo study, an in vitro comparative dissolution test was performed by the paddle method following the bioequivalence guidance of the Korea Food and Drug Administration (KFDA). By the results of the dissolution test it was demonstrated from the similar and rapidly dissolving patterns of the two lisinopril tablets that the two formulations were pharmaceutically equivalent. However, the in vivo bioequivalence study was required to fully evaluate the bioequivalence of the two drug products. In the in vivo bioequivalence study, the plasma samples drawn from the volunteers were analyzed utilizing a sensitive LC-MS-MS analysis method and the bioequivalence between the two drug products was assessed by statistical analysis of the log transformed mean ratios of Cmax,AUC(0-t) and AUC(0-infinity). The mean maximum concentration (Cmax) of the test and reference were found to be 60.41 +/- 20.07 ng/mL and 61.11 +/- 19.36 ng/mL, respectively. The 90% confidence intervals (C.I.) of Cmax were in the range from 0.91 to 1.08. As for the AUC(0-t) and the AUC(0-infinity), test values were 792.73 +/- 273.41 ng x mL(-1) x h, 862.74 +/- 303.81 ng x mL(-1) x h and the reference values were 841.66 +/- 286.07 ng . mL(-1) x h, 906.97 +/- 318.72 ng x mL(-1) x h, respectively. The 90% C. I. of AUC(0-t) were 0.86 to 1.01 and of AUC(0-infinity), 0.87 to 1.02 and thus were within the 80-125% interval proposed by the FDA. In addition to the 90% C.I. of the pharmaceutical parameters, a two-way ANOVA showed no significant difference between the two formulations. Based upon these statistical analyses, it was concluded that the test formulation is bioequivalent to the reference.
机译：通过体内和体外测试证明了赖诺普利（CAS 83915-83-7）的测试制剂（纳诺普利，“测试”）和参考制剂（“参考”）的生物等效性。在26位健康志愿者中进行的体内生物等效性研究设计为单剂量，随机，双盲试验，两次给药之间有2周的清除期。在体内研究之前，按照韩国食品药品监督管理局（KFDA）的生物等效性指南，通过桨法进行了体外比较溶出度试验。通过溶解试验的结果，从两种赖诺普利片剂的相似且快速溶解的模式证明，两种制剂在药学上是等效的。但是，需要进行体内生物等效性研究来全面评估两种药物的生物等效性。在体内生物等效性研究中，使用灵敏的LC-MS-MS分析方法分析了从志愿者那里采集的血浆样本，并通过对Cmax，AUC（n）的对数转换后的平均比率进行统计学分析来评估两种药物产品之间的生物等效性。 0-t）和AUC（0-无穷大）。测试和参考的最大平均浓度（Cmax）分别为60.41 +/- 20.07 ng / mL和61.11 +/- 19.36 ng / mL。 Cmax的90％置信区间（C.I.）在0.91至1.08的范围内。对于AUC（0-t）和AUC（0-无穷大），测试值分别为792.73 +/- 273.41 ng x mL（-1）xh，862.74 +/- 303.81 ng x mL（-1）xh和参考值为841.66 +/- 286.07 ng。 mL（-1）x h，分别为906.97 +/- 318.72 ng x mL（-1）x h。 90％C. I.的AUC（0-t）为0.86至1.01，而AUC（0-无穷大）为0.87至1.02，因此在FDA建议的80-125％区间内。除了90％的C.I.在药物参数方面，双向方差分析显示两种制剂之间无显着差异。基于这些统计分析，可以得出结论，该测试制剂与参考物具有生物等效性。

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