奥美拉唑肠溶胶囊在健康人体的药代动力学及生物等效性研究
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摘要
目的研究两个不同厂家生产的奥美拉唑肠溶胶囊在健康人体的生物等效性。方法 20例健康受试者进行双周期交叉试验。用高效液相色谱法测定血清中奥美拉唑浓度,血药浓度-时间数据用DAS2. 0统计软件处理,计算主要药代动力学参数,并进行两种制剂的生物等效性评价。结果受试制剂及参比制剂的t_(1/2)分别为(1. 79±0. 86),(1. 49±0. 50) h,C_(max)分别为(0. 51±0. 25),(0. 49±0. 12)μg·mL~(-1),t_(max)分别为(2. 05±0. 64),(2. 04±0. 63) h,AUC_(0-12) h分别为(1. 64±1. 41),(1. 57±0. 99)μg·h~(-1)·mL~(-1)。受试制剂的相对生物利用度为(101. 48±33. 82)%。结论两种奥美拉唑肠溶胶囊具有生物等效性。
Objective To investigate the bioequivalence of omeprazole enteric-coated capsules of two manufactories in Chinese healthy volunteers. Methods Twenty volunteers were randomly divided into test and reference groups,with double cross-over design. The concentration of omeprazole in serum was determined by high performance liquid chromatography( HPLC) and pharmacokinetic parameters were calculated with DAS2. 0 practical pharmacokinetics program. Results The pharmacokinetic parameters of the test and reference preparation were as follows: t_(1/2) were( 1. 79 ± 0. 86),( 1. 49 ± 0. 50) h; C_(max)were( 0. 51 ± 0. 25),( 0. 49 ± 0. 12) μg·mL~(-1),t_(max)were( 2. 05 ± 0. 64),( 2. 04 ± 0. 63) h,AUC_(0-12) hwere( 1. 64 ± 1. 41),( 1. 57 ± 0. 99) μg · h~(-1)·mL~(-1),respectively. The relative bioavalibility of the test peparation was( 101. 48 ± 33. 82) %. Conclusion The statistical analysis showed that the test and reference preparations were bioequivalent.
Objective To investigate the bioequivalence of omeprazole enteric-coated capsules of two manufactories in Chinese healthy volunteers. Methods Twenty volunteers were randomly divided into test and reference groups,with double cross-over design. The concentration of omeprazole in serum was determined by high performance liquid chromatography( HPLC) and pharmacokinetic parameters were calculated with DAS2. 0 practical pharmacokinetics program. Results The pharmacokinetic parameters of the test and reference preparation were as follows: t_(1/2) were( 1. 79 ± 0. 86),( 1. 49 ± 0. 50) h; C_(max)were( 0. 51 ± 0. 25),( 0. 49 ± 0. 12) μg·mL~(-1),t_(max)were( 2. 05 ± 0. 64),( 2. 04 ± 0. 63) h,AUC_(0-12) hwere( 1. 64 ± 1. 41),( 1. 57 ± 0. 99) μg · h~(-1)·mL~(-1),respectively. The relative bioavalibility of the test peparation was( 101. 48 ± 33. 82) %. Conclusion The statistical analysis showed that the test and reference preparations were bioequivalent.
引文
[1]KARLJIKOVIC-RAJIC K,NOVOVIC D,MARLNKOVIC V,et al.First-order UV-erivative spectrophotometry in the analysis of omeprazole and pantoprazole sodium salt and corresponding impurities[J].J Pharm Biomed Anal,2013,32(4-5):1019-1027.
[2]陈新谦,金有豫,汤光.新编药物学[M].5版.北京:人民卫生出版社,2013:433-4341.
[3]邓鸣,张晓丽,侯艳宁.高效液相色谱法测定人血浆中奥美拉唑浓度[J].中国药事,2016,20(12):759-761.
[4]王平全,安富荣,刘振,等.奥美拉唑肠溶胶囊人体相对生物利用度[J].中国医院药学杂志,2012,22(8):453-456.
[5]刘玉波,郭涛,隋因,等.HPLC法测定人血浆中奥美拉唑浓度[J].中国临床药学杂志,2016,15(5):303-306.
[6]付良青,黄丰,吴德政,等.中国健康志愿者的奥美拉唑及其代谢产物的药代动力学[J].中国药理学与毒理学杂志,2013,17(1):51-54.
[2]陈新谦,金有豫,汤光.新编药物学[M].5版.北京:人民卫生出版社,2013:433-4341.
[3]邓鸣,张晓丽,侯艳宁.高效液相色谱法测定人血浆中奥美拉唑浓度[J].中国药事,2016,20(12):759-761.
[4]王平全,安富荣,刘振,等.奥美拉唑肠溶胶囊人体相对生物利用度[J].中国医院药学杂志,2012,22(8):453-456.
[5]刘玉波,郭涛,隋因,等.HPLC法测定人血浆中奥美拉唑浓度[J].中国临床药学杂志,2016,15(5):303-306.
[6]付良青,黄丰,吴德政,等.中国健康志愿者的奥美拉唑及其代谢产物的药代动力学[J].中国药理学与毒理学杂志,2013,17(1):51-54.