Study of the relative bioequivalence of sustained release capsules of Ibuprofen in healthy volunteers

Abstract

Abstract: AIM: To study the relative bioequivalence of sustained release capsules of Ibuprofen made by Jiangxi Pharmaceutical Co., Ltd.METHODS: A single dose of 300 mg domestic Ibuprofen, and its reference preparation made by Zhengzhou Fusheng Pharmaceuticals Co.,Ltd. were given to 24 healthy volunteers by oral in an open randomized two way crossover experiment.The plasma concentrations were determined by HPLC method.RESULTS: The main pharmacokinetic parameters of a single dose of Ibuprofen were as follows : C_max were (13.5±5.9) and (12.7±5.4) μg/mL; t_max were (5.1±1.0), (5.5±1.5) h; AUC_0-24 were (100.2±45.4) and (98.5±44.8) μg·h·mL^-1;AUC_0→∞ were (105.7±47.3) and (103.8±47.0) μg·h·mL^-1 for the reference drug and the test drug, respectively.The main pharmacokinetic parameters of muti-dose of Ibuprofen were as follows: C_max were (14.1±5.3) and (14.9±6.4) μg/mL;C_av were(8.2±3.4 )and (8.6±4.3) μg/mL; t_max were (4.8±1.0) and (4.6±0.9) h; AUC_ss were (99.0±40.4) and (103.3±51.3) μg·h·mL^-1 for the reference drug and the test drug, respectively.CONCLUSION: Statistic analysis shows that the reference preparation and the test preparation are bioequivalent.

Key words: Ibuprofen, Relative bioavailability, Pharmacokinetics

CLC Number:

R917

TIAN Wei-chao, YANG Rui, SHEN Jie, XIE Hai-tang, WANG Fang-jie, XIAO Jian. Study of the relative bioequivalence of sustained release capsules of Ibuprofen in healthy volunteers[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2013, 18(5): 545-549.

References

[1] 张皓,杨金荣,高顺昌,等. HPLC法测定精氨酸布洛芬喷雾剂的含量[J].天津医科大学学报, 2010,16(2):229-231.
[2] 王友新,刘俊波,阎广华,等. HPLC 法测定小儿布洛芬口服溶液中布洛芬的含量[J].中国医药导报,2010,7(30):48-49.
[3] 商闯,杨更亮.布洛芬缓释片的人体生物等效性研究[J].中国药房,2008,19(20):1553-1554.
[4] 杜震,田春莲,隋杨,等.布洛芬颗粒的人体药动学及生物等效性研究[J].药学服务与研究,2009,9(6):436-439.
[5] 万元胜,陈华庭,陈东生.布洛芬颗粒剂的人体生物等效性研究[J].中阅药师,2008,11(5):508-510.
[6] 余自成,陈冰,张伟霞,等.布洛芬口腔崩解片的人体相对生物利用度和生物等效性[J].中国临床药学杂志,2006,15(5):280-283.
[7] 温金华,程晓华,蔡军,等.布洛芬片人体药代动力学及生物等效性研究[J].江西医学院学报,2007,47(6):30-32.
[8] 张运好,胡玉钦,侯艳宁.布洛芬软胶囊的人体生物等效性研究[J].医学理论与实践,2009,22(2):144-146.
[9] 宝炉丹,于莉,郭云珍,等.布洛芬软胶囊人体生物等效性研究[J].中国新药杂志,2006,15(23):2062-2064.
[10] 黄海卫,谢昭明,李顺祥,等.布洛芬糖浆含量测定方法研究[J]. 医药导报,2009,28(7):933-934.
[11] 薛洪源,周新腾,王宇奇,等.单剂量及多剂量口服布洛芬缓释胶囊的药物动力学与生物等效性研究[J].中国医药工业杂志,2006,37(10):693-696.
[12] 邓鸣,杨汉煌,张彦玲,等.复方布洛芬软胶囊的人体药动学和生物等效性[J].中国新药与临床杂志,2006,25(12):905-908.
[13] 刘忠,宋红萍,徐隽,等.高效液相色谱法测定布洛芬注射液的含量及有关物质[J].中国医院药学杂志,2009,29(10):856-858.
[14] 谢斌,丁玉峰,贺国芳,等.高效液相色谱法测定右旋布洛芬缓释栓的含量及有关物质[J].中国药师,2008,11(10):1178-1180.
[15] 王润玲,张庆伟,杨金荣,等.精氨酸布洛芬糖浆与布洛芬片剂人体药动学及生物等效性比较[J].中国新药与临床杂志,2006,25(1):52-54.
[16] 郭琦,傅强,潘永西,等.气相色谱法测定布洛芬片的含量[J].中国药业,2009,18(15):21-22.