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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 determine the bioequivalence of ranitidine hydrochloride effervescent granules. Methods: Ten male healthy volunteers were given oral administration of ranitidine hydrochloride effervescent granules and ranitidine hydrochloride capsules. The bioequivalence of the drug in human serum was determined by HPLC. The mobile phase consisted of 0.02mol·L-1 potassium dihydrogen phosphate solution-methanol (70:30) with a flow rate of 1.0mL · min-1 at a detection wavelength of 320nm using ALLTMA C18 as the stationary phase. Results: The plasma concentration of effervescent granules and capsules all fit the two-compartment model. The main pharmacokinetic parameters of Tpeak were (1.96 ± 0.55) h and (2.21 ± 0.39) h, respectively, and the Cmax were (665 ± 213) μg · L-1 and (547 ± 181) μg · L- (3452 ± 601) h · μg · L-1 and (3053 ± 579) h · μg · L-1, respectively. There was no significant difference (P> 0.05) between the parameters of paired t-test, and the bioequivalence of effervescent granules was 108% after the content was corrected. Conclusions: The results show that effervescent granules and capsules have bioavailability equivalency.