尼群地平缓释片剂的研究

研究了尼群地平缓释片剂的处方、制备工艺和溶出速率,用GC-MS法测定了12名健康受试者口服自制缓释片(C)、市售国产片剂(A)和进口某公司片剂(B)后的体内血药浓度,体内数据按零级溶出、一级吸收口服单室模型,经计算求得药动学参数。结果表明,A、C两制剂相对于B制剂的生物利用度为31.8％及64.8％。与普通片剂相比,缓释片血浓度曲线较为平坦且下降缓慢。

STUDY ON SUSTAINED-RELEASE NITRENDIPINE TABLET

The formulation, preparation, dissolution of sustained releasenitrendipine tablet was studied. The domestic tablet A and the sustained releasetablet C were compared with the imported tablet B in vivo, The determinationof nitrendipine was carried out by GC-MS. The pharmacokinetic parameters invivo of nitrendipine were-estimated by using the nonlinear least square compu-ter program on the basis of the compartment model(zero order dissolution, firstorder absorption). The bioavailability of A and C relative to B was 31.8%, 64.8%respectively. A smoother curve of nitrendipine concentration in plasma wasobtained.