盐酸雷尼替丁泡腾颗粒剂的生物等效性研究  

Bioequivalence of Ranitidine Hydrochloride Effervescent Granules in Healthy Volunteers

作　　者：李会林[1] 高素英[1] 金鸥[1] 殷国真[1] 

机构地区：[1]浙江省药品检验所,杭州310004

出　　处：《药物分析杂志》2001年第6期434-436,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:测定盐酸雷尼替丁泡腾颗粒剂的生物等效性。方法:10名男性健康志愿者交叉口服盐酸雷尼替丁泡腾颗粒剂和盐酸雷尼替丁胶囊,采用HPLC法测定人血清中药物浓度进行生物等效性的研究。以ALLTMA C18为固定相,0.02mol·L-1磷酸二氢钾溶液-甲醇（70:30）为流动相,流速1.0mL·min-1,检测波长为320nm。结果:泡腾颗粒剂与胶囊的血药浓度曲线均符合二室模型。其主要药物动力学参数:Tpeak分别为（1.96±0.55）h和（2.21±0.39）h,Cmax分别为（665±213）μg·L-1和（547±181）μg·L-1,AUC分别为（3452±601）h·μg·L-1和（3053±579）h·μg·L-1。各参数经配对t-检验处理,均无显著差异（P>0.05）,泡腾颗粒剂的生物等效性经含量校正后为108％。结论:结果表明泡腾颗粒剂与胶囊剂具有生物利用等效性。Objective: To study the bioequivalence of ranitidine in 10 normal male volunteers. Methods: A single oral dose of 150 mg ranitidine hydrochloride effervescent granules or capsules of ranitidine was given according to across over design. The concentration in plasma was determined by HPLC. The extract was analyzed subsequently on ALLTIMA C18 column with 0.02 mol·L-1 potassium dihydrogen phosphate - methanol ( 70:30) as mobile phase, the flow rate was 1.0 mL·min-1, detected at 320 mn. Results: The concentration - time curves of ranitidine hydrochloride effervescent granules and capsules products fitted to two - compartment open model. The main pharmacokinetic parameters were: Tpeak (1.96±0.55) h and (2.21±0.39) h, Cmax (665±213)μg·L-1 and (547±181)μg·L-1,AUC (3452± 601) h·μg·L-1 and (3 053±579) h·μg·L-1 . The pharmacokinetic parameters obtained from our studies showed no significant difference between the two products ( P > 0.05) . By content calibration relative bioequivalence of ranitidine hydrochloride effervescent granules was 108% . Conclusion: The results suggested that the bioequivalence of the twe preparations was similar.

关 键 词：盐酸雷尼替丁 泡腾颗粒剂 生物等效性 高效液相色谱法 H2受体拮抗剂 血药浓度 

分 类 号：R972[医药卫生—药品]