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为了提高尼群地平片(nitrendipine)的生物利用度,利用混合粉碎法工艺制备了新处方片剂(D)和胶囊剂(E),并为降低尼群地平的副作用,使之作用平缓,又研制了缓释片(F)。本研究进行了以下工作:比较了国产原料(南京制药厂)与国外原料(联邦德国Bayer厂)的晶型;测定了尼群地平原料、气流粉碎后的原料和研磨物的粒径;将国产片剂(A)(南京制药厂)、(C)(河北××制药厂)与D、E、F和国外产片剂(B)(联邦德国Bayer厂)进行了体外溶出、体内血浓测定比较;建立了尼群地平体内血浓测定方法;应用电子计算机技术进行了各制剂的模型嵌合,求取药动学参数;探讨了制剂生物等效性问题,观察了各制剂在
In order to improve the bioavailability of nitrendipine, new prescription tablets (D) and capsules (E) were prepared by a mixing and crushing process. In order to reduce the side effects of nitrendipine, Developed sustained-release tablets (F). In this study, the following work was carried out: the crystal forms of domestic raw materials (Nanjing Pharmaceutical Factory) and foreign raw materials (Bayer factory in Federal Republic of Germany) were compared; the particle size of nitrendipine raw materials and air-ground pulverized raw materials and grinding materials was measured; In vitro dissolution of the tablets (A) (Nanjing Pharmaceutical Factory), (C) (Hebei ×× Pharmaceutical Factory) and D, E, F and the foreign produced tablets (B) (Bayer Plant, Federal Republic of Germany) Compared with that of nitrendipine; established the method of blood concentration determination of nitrendipine in vivo; the model fitting of each formulation was carried out by computer technology, and the pharmacokinetic parameters were obtained; the bioequivalence of the formulation was discussed,