尼群地平胶囊剂的研制

采用球磨混合粉碎法工艺进行处方设计,试制出尼群地平胶囊剂。将国产片剂(南京制药厂)、自制胶囊剂与西德Bayer公司片剂进行体外溶出、体内血浓测定比较,体内血浆药浓用GC-MS法测定,体内数据按零级溶出、一级吸收口服单室模型经计算机处理求得药动学参数。研制的尼群地平胶囊剂与西德Bayer公司片剂生物等效。

Studies on the Nitrendipine Capsule

The nitrendipine capsule was developed by using ground milling method. The commercially conventional tablet A (Nanjing factory) and capsule C were compared with the reference tablet B (Bayer Company, Germany) in vitro and vivo. The dctcrmination of nitrendipine in vivo was carried out by GC-MS. The pharmacokinetic parameters in vivo of nitrendipinc were estimated by using the nonlinear least square computer program on the basis of the compartment model (Zero order dissolution, first ordcr absorption). The bioavailability of A and C relafive to B was 31.8% and 126.1% rcspcctivcly.