复方雷尼替丁颗粒中雷尼替丁的生物等效性的探究.pdfVIP

复方雷尼替丁颗粒中雷尼替丁的生物等效性研究 朱荣华* 朱南平 程泽能 彭文兴 王峰 李焕德 中南大学湘雅二医院药剂科 长沙 410011 摘要 目的 研究海南长安国际制药有限公司研制的复方雷尼替丁颗粒中雷尼替丁的相对生物利用 度 方法 采用随机 开放 双周期交叉试验设计 20 名男性健康受试者分别单剂量口服含300 mg 雷尼替丁的试验制剂或参比制剂 采用HPLC-MS 法测定给药后不同时间的雷尼替丁血药浓度 结果 参比制剂和试验制剂中雷尼替丁的主要药代动力学参数分别为 Cmax 为1037.2 428.1 ìg· L-1 和1139.3 465.4ìg· L-1 tmax 为2.1 0.5 h 和1.8 0.3 h AUC0 12 为3772.9 1238.1 ìgh· L-1 和3564.1 1145.4 ìgh· L-1 t1/2 为2.8 0.7 h 和2.8 0.5 h 试验药的相对生物利用度F 为95.2% 9.2% 结论 试验制 剂与对照制剂具有生物等效性 关键词 雷尼替丁 药代动力学 生物利用度 高效液相色谱-质谱法 Relative Bioavailability of Ranitidine in Healthy Volunteers Zhu Nan-ping, Zhu Rong-hua*, Cheng Ze-neng, Peng Wen-xing, Wang Feng, Li Huan-de The Department of Pharmacy of the 2nd hospital of central south university, Changsha, 410011 Abstract OBJECTIVE: To study pharmacokinetics and relative bioavailability of ranitidine in 20 healthy male volunteers. METHODS: A single oral at dose of 300 mg ranitidine were administrated according to randomized-cross design. The ranitidine in plasma was detected by HPLC-MS. RESULTS: The pharmacokinetic -1 parameters of test formulation and compare formulation were as followings: Cmax were 1037.2 428.1ìg · L and 1139.3 465.4ìg · L-1 tmax were 2.1 0.5 h and 1.8 0.3 h AUC0 12 were 3772.9 1238.1 ìgh· L-1 and 3564.1 1 145.4 ìgh· L-1 t1/2 were 2.8 0.7 h and 2.8 0.5 h. The extent of relative bioavailability of ranitidine, based on the AUC0 12 data, was 95.2% 9.2%, with a 90% confidence interval of 95.4%-99.3%. CONCLUSION: The result showed that the two formulations are bioequivalent. Keywords ranitidine; bioavailability; HPLC-MS 雷尼替丁 ranitidine, RAN 又名呋喃硝胺 是一种疗效肯定 不良反应小 作用持久的组胺H2 受体阻滞剂 H RA