摘要
[目的]评价新药布洛伪麻那敏缓释胶囊(试验制剂)和市售布洛伪麻缓释胶囊加马来酸氯苯那敏片(参比制剂)在人体内是否生物等效。[方法]自身对照设计,将26名健康受试者随机分组后交叉口服试验制剂和参比制剂,采用HPLC-MS/MS法测定血浆中布洛芬、伪麻黄碱和氯苯那敏的经时血药浓度,用DAS2.0程序计算药代动力学参数,比较两种制剂的生物利用度。[结果]布洛芬、伪麻黄碱、氯苯那敏的相对生物利用度分别为101.9%、93.7%、94.6%。[结论]试验制剂与参比制剂生物等效。
[Objective] To evaluate the bioavailability of pseudo ephedrine and ibuprofen, pseudo ephedrine with Chlorpheniramine in human body. [ Methods] By self-control design, 26 health volunteers were randomly divided into two groups, and oral adnfinistrated with test capsule and refepence capsule. The plasma concentration of ibuprofen, pseudo ephedrine and ctfiorphenamine were measured simultaneously by HPLC-MS/MS. The phannacokinedcs parameters were calculated with DAS 2.0 pharmacokinetic software. The biological availability of the two preparations was compared. [Results] Tile relative bioavailability of ibuprofen, pseudo ephedrine and chlorphenamine were 101.9%, 93.7% and 94.6%, respectively. [Conclusion] The test capsule showed to be bioequivalence to the reference capsule.
出处
《现代预防医学》
CAS
北大核心
2008年第12期2301-2303,共3页
Modern Preventive Medicine
