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目的建立高效液相色谱(HPLC)和电感耦合等离子体-质谱(ICP-MS)分别测定人血浆中雷尼替丁和铋质量浓度的方法 ,并应用该法进行雷尼替丁和铋在健康人体内的药动学特征研究和复方盐酸雷尼替丁片生物等效性评价。方法采用HPLC法和ICP-MS技术,分别测定20名健康男性受试者经口给予复方盐酸雷尼替丁片和复方雷尼替丁胶囊后不同时刻血浆中雷尼替丁和铋的质量浓度,分别绘制血药质量浓度-时间曲线,并计算主要药动学参数。结果受试制剂和参比制剂中雷尼替丁的主要药动学参数如下:tmax分别为(1.9±0.5)和(2.1±0.6)h,ρmax分别为(492.8±276.7)和(466.5±224.4)μg.L-1,t1/2分别为(2.9±1.6)和(2.8±1.0)h,用梯形法计算,AUC0-t分别为(2 548.3±895.6)和(2 377.5±887.0)μg.h.L-1,AUC0-∞分别为(2 562.9±912.8)和(2 377.5±887.0)μg.h.L-1,雷尼替丁的相对生物利用度平均为(111.6±35.4)%。受试制剂和参比制剂中铋的主要药动学参数如下:tmax分别为(0.4±0.2)和(0.3±0.1)h,ρmax分别为(56.0±40.2)和(53.3±37.9)μg.L-1,t1/2分别为(6.9±2.6)和(7.2±2.3)h,用梯形法计算,AUC0-t分别为(151.8±118.9)和(156.3±117.9)μg.h.L-1,AUC0-∞分别为(153.1±120.2)和(157.7±119.3)μg.h.L-1,铋的相对生物利用度平均为(95.3±16.2)%。结论复方盐酸雷尼替丁片与复方雷尼替丁胶囊两种制剂具有生物等效性。
OBJECTIVE To establish a method for the determination of ranitidine and bismuth concentrations in human plasma by high performance liquid chromatography (HPLC) and inductively coupled plasma mass spectrometry (ICP-MS), and apply the method for the determination of ranitidine and bismuth in healthy Study on Pharmacokinetics in Human Body and Bioequivalence Evaluation of Ranitidine Hydrochloride Tablets. Methods The plasma concentrations of ranitidine and bismuth were measured in 20 healthy male subjects by oral administration of ranitidine hydrochloride and compound ranitidine capsules by HPLC and ICP-MS respectively. , Respectively, drawn plasma concentration-time curve, and calculate the main pharmacokinetic parameters. Results The main pharmacokinetic parameters of ranitidine in test and reference preparations were as follows: tmax = (1.9 ± 0.5) and (2.1 ± 0.6) h, ρmax = (492.8 ± 276.7) and (466.5 ± 224.4 ) μg.L-1 and t1 / 2 were (2.9 ± 1.6) and (2.8 ± 1.0) h, respectively, and the AUC0-t was (2 548.3 ± 895.6) and (2 377.5 ± 887.0) μg, respectively. hL-1 and AUC0-∞ were (2 562.9 ± 912.8) and (2 377.5 ± 887.0) μg.hL-1, respectively. The relative bioavailability of ranitidine was (111.6 ± 35.4)%. The main pharmacokinetic parameters of bismuth in the test and reference preparations were as follows: tmax was (0.4 ± 0.2) and (0.3 ± 0.1) h, and pmax was (56.0 ± 40.2) and (53.3 ± 37.9) -1 and t1 / 2 were (6.9 ± 2.6) and (7.2 ± 2.3) h, respectively. The AUC0-t was (151.8 ± 118.9) and (156.3 ± 117.9) μg.hL- ∞ were (153.1 ± 120.2) and (157.7 ± 119.3) μg.hL-1, respectively. The relative bioavailability of bismuth was 95.3 ± 16.2%. Conclusion Compound ranitidine hydrochloride and compound ranitidine capsules are bioequivalent.