兰索拉唑片人体生物利用度和生物等效性的临床研究

发布时间：2018-06-14 23:28

本文选题：兰索拉唑 + 生物等效性　；参考：《山东大学》2014年硕士论文

【摘要】：采用高效液相色谱法(HPLC)法测定健康受试者血清中兰索拉唑浓度。方法验证结果显示血清杂质不干扰样品测定,线性范围：0.028～2.80μg/ml,最低定量下限0.028μg/ml,平均提取回收率为79.69%～94.73%,日内和日间的相对标准差(RSD)均小于15%。该方法符合生物样品分析要求。 24名健康志愿者按体重随机、配对交叉口服试验制剂兰索拉唑片和参比制剂兰索拉唑片,剂间间隔为1周,剂量均为30mg。用HPLC法测定血清中兰索拉唑浓度,实验结果为：试验制剂t1/22.166±1.217h、Cmax1.644±0.677μg/ml、Tmax2.688±0.640h、AUC0.15h5.977±3.692μg·h/ml;参比制剂t1/21.771±0.763h、Cmax1.490±0.569μg/ml、Tmax3.292±0.779h. AUC0-15h5.609±3.015μg·h/ml。以汕头经济特区泙滨制药厂的兰索拉唑片为参比制剂,用面积法估算济南利民制药有限责任公司的兰索拉唑片的相对生物利用度为105.46%±33.03%,符合生物利用度要求。试验制剂和参比制剂In(AUC0-15h)、In(AUC0-∞)经方差分析,结果表明两制剂间无显著性差异,经双向单侧t检验,两制剂[1-2a]置信区间分别为89.7%-112.7%、91.3%-115.1%,在80%-125%范围内,说明两制剂在吸收程度上具有生物等效性。试验制剂和参比制剂In(Cmax)经方差分析,两制剂间无显著性差异,经双向单侧t检验,两制剂[1-2α]置信区间在70%-143%范围内,说明两制剂在达峰浓度上具有生物等效性。
[Abstract]:The concentration of lansoprazole in the serum of healthy volunteers was determined by high performance liquid chromatography (HPLC). The results showed that the serum impurity did not interfere with the determination of samples. The linear range was: 0.028 ~ 2.80 渭 g / ml, the lowest limit of quantification was 0.028 渭 g / ml, the average recovery was 79.69 ~ 94.73 and the relative standard deviation between day and day was less than 15g / ml. The method met the requirements of biological sample analysis. Twenty-four healthy volunteers were randomly matched to each other according to their body weight to take lansoprazole tablets and lansoprazole tablets with an interval of 1 week and a dose of 30 mg. The concentration of lansoprazole in serum was determined by HPLC. The experimental results were as follows: t _ 1 / 22.166 卤1.217 h ~ (-1) C _ (max1.644 卤0.677) 渭 g 路ml ~ (-1) C _ (max) 2.688 卤0.640 h AUC _ (0.15) h 5.977 卤3.692 渭 g 路h ~ (-1) ml 路ml ~ (-1), t _ (1) / (21.771 卤0.763) h ~ (max) 1.490 卤0.569 渭 g 路ml ~ (-1) T _ (max3.292 卤0.779 h). AUC 0-15 h 5.609 卤3.015 渭 g / h 路ml. Taking lansoprazole tablets of Shantou Special Economic Zone as reference preparation, the relative bioavailability of Lansoprazole tablets of Jinan Liming Pharmaceutical Co., Ltd was estimated to be 105.46% 卤33.03, which met the requirement of bioavailability. The results of ANOVA showed that there was no significant difference between the two preparations. The confidence intervals of the two preparations [1-2a] were 89.7-112.7%, 91.3% -115.1%, respectively, in the range of 80-125%. It shows that the two preparations have bioequivalence in the degree of absorption. There was no significant difference between the two preparations by ANOVA. The confidence interval of [1-2 伪] between the two preparations was within 70% -143%, which indicated that the two preparations had bioequivalence in the peak concentration.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R969

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