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双氯灭痛缓释片在中国人体内药代动力学和相对生物利用度

季爱民, 邹恒琴, 张忠义, 车瓯   

  1. 广州第一军医大学附属珠江医院药材科, 广州 510282
  • 收稿日期:1993-10-26 修回日期:1994-01-12 出版日期:1995-03-15 发布日期:1995-03-15

Pharmacokinetics and Relative Bioavailability ofsustained-release Tablets of Diclofenac Sodiumin Male Volunteers

Ai-Min Ji, Heng-Qin Zou, Zhong-Yi Zhang, Ou Che   

  1. Pharmacy of Zhujiang Hospital; First Military Medical University; Guangzhou 510282
  • Received:1993-10-26 Revised:1994-01-12 Online:1995-03-15 Published:1995-03-15

摘要: 八名健康男性志愿者单剂量随机交叉服用100 mg双氯灭痛缓释片及肠溶衣片后, HPLC法测定血药浓度。体内药物浓度符合一室开放模型。肠溶衣片及缓释片的T1/2 (Ke) 分别为2.15±0.1711.60±l.95 h; 药物浓度曲线下面积分别为5.87±0.675.55±0.57 μg·h/ml。缓释片对肠溶衣片的相对生物利用度为0.95 (P>0.05)

关键词: 双氯灭痛, 药代动力学, 缓释, 肠溶衣, 相对生物利用度

Abstract: The pharmacokinetics of a sustained- release formulation and an enteric-coated tablet of diclofenac sodium were studied on 8 healthy male volunteers in an open, randomized crossover study. Drug level in serum was assayed by HPLC method. The changes in serum concentration were conformed to a l-compartment open model. The t1/2 (Ke) averaged 2.15±0.17 and 11.60±l.95 h, and the areas under the drug concentration curves were 5.87±0.67 and 5.55±0.57 μg·h/ml for enteric-coated and sustained-release tablet of diclofenac sodium, respectively. The mean relative bioavailability of sustained-release tablet was 0.95 to that of enteric-coated tablet.

Key words: Diclofenac sodium, Pharmacokinetics, Sustained-release, Enteric-coated, Rela tive bioavailability

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