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目的研究2种硫酸氨基葡萄糖胶囊在健康受试者体内的药动学和生物等效性。方法22名男性健康受试者,单剂量随机交叉口服不同厂家硫酸氨基葡萄糖胶囊500 mg后,采用LC-MS/MS法测定血药浓度,用DAS 2.0统计软件计算药动学参数和相对生物利用度。结果受试者口服受试制剂和参比制剂后的ρmax分别为(5ρ2.0±193.0)、(453.0±174.0)μg·L-1,tmax分别为(2.9±1.5)、(2.5±1.3)h,t1/2分别为(1.3±0.4)、(1.2±0.4)h,AUCO→t分别为(1 997.0±652.0)、(1 948.0±715.0)μg·h·L-1,AUC+(O→∞)分别为(2 027.0±657.0)、(1 972.0±716.0)μg·h·L-1;受试制剂的相对生物利用度为(106.7±27.8)%。结论2种制剂具有生物等效性。
Abstract：AIM To study the pharmacokinetics and bioequivalence of glucosamine sulfate capsules in Chinese healthy volunteers.METHODS Twenty-two healthy male volunteers were enrolled in a randomized crossover study in which the subjects were randomly assigned to receive a single dose of 500 mg glucosamine sulfate capsules of different factories.The drug concentrations in human plasma were determined by LC-MS/MS assay.The pharmacokinetic parameters of glucosamine sulfate were calculated by DAS 2.0 software.RESULTS The relative pharmacokinetic parameters of glucosamine sulfate in test and reference formulations were as follows:ρmax(502.0±193.0) and(453.0±174.0)μg·L-1;tmax(2.9±1.5)and(2.5±1.3) h;t1/2(1.3±0.4)and(1.2±0.4)h;AUC0→t(1997.0±652.0) and (1948.0±715.0)μg·h·L-1;AUC0→∞(2027.0±657.0) and(1972.0±716.0)μg·h·L-1.The relative bioavailability of the tested capsule was(106.7±27.8)%.CONCLUSION The two kinds of glucosamine sulfate capsules proved to be bioequivalent.
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基本信息:
DOI：10.19577/j.cnki.issn10074406.2009.06.004
中图分类号:R96
引用信息:
[1]潘杰,张全英,张逸凡,等.LC-MS/MS法测定人血浆中硫酸氨基葡萄糖的浓度及其人体生物等效性[J].中国临床药学杂志,2009,18(06):341-345.DOI:10.19577/j.cnki.issn10074406.2009.06.004.
2009-11-25
2009-11-25