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为研究被试制剂国产西沙必利片剂和参比制剂的药代动力学和人体生物等效性，用高效液相荧光检测法院测定１２名健康受试者口服１５ｍｇ后，血浆中西沙必利的浓度，经３Ｐ９７拟合，两者在体内的过程皆符合血管外给药二室开放模型，被试制剂和参比制剂的：ＡＵＣ为７２９．７８±５４．５２ μｇ·ｈ·Ｌ~（－１）和７０９．８５±５７．μＧｇ·ｈ~（－１），Ｔ_（ｐｅａｋ）分别为１．４７±０．１８ｈ和１．４０±０．２６ｈ，Ｃ_（ｍａｘ）分别为６５０８±２５７ －μｇ·Ｌ~（－１）和６４．００±３．９６μｇ Ｌ~（－１），Ｔ_（１／２β）分别为 ８．８０４± ０．８６６ｈ和 ８．４７５± ０．９３２ｈ，经配对 ｔ－检验，两者的 Ａ ＵＣ，Ｔ_（ｐｅａｋ），Ｃ_（ｍａｘ），Ｔ_（１／２β）等主要药代动力学参数均无显著性差异（Ｐ＞０．０５）。采用梯形法计算的两者的 ＡＵＣ_（０－ｔ），实测 Ｃ_（ｍａｘ）、 Ｔ_（ｐｅａｋ）。值进行统计学分析，结果表明被试制剂和参比制剂具有生物等效性。国产西沙必利片的相对生物利用度为！０２．５％± ５．０％。
In order to study the pharmacokinetics and bioequivalence of test-produced domestic cisapride tablets and reference preparations, 12 healthy volunteers were tested for oral pharmacokinetics and plasma bioavailability using a high-performance liquid fluorescence detection court. After oral administration of cisapride The results showed that the AUC was 729.78 ± 54.52 μg · h · L ~ (-1) for the test preparation and the reference preparation by 3P97 fitting, both in vivo and in vivo. -1) and 709.85 ± 57. μGg · h -1 and T peak were 1.47 ± 0.18h and 1.40 ± 0.26h respectively, the max values of C max were 6508 ± 257μg · L -1 and 64.00 ± 3.96μg L -1 and T 1/2 1/2 were 8.804 ± 0.866h and 8.475 ± 0.932h, respectively. The paired t-test showed that the AUC, There were no significant differences in the main pharmacokinetic parameters such as T_ (peak), C_ (max) and T_ (1 / 2β) (P> 0.05). The AUC_ (0-t) of the two calculated by the trapezoidal method, the measured C_ (max), T_ (peak). Value of statistical analysis, the results showed that the test preparations and reference formulations with bioequivalence. The relative bioavailability of domestic cisapride tablets is! 02.5% ± 5.0%.