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目的评价麻敏维C缓释胶囊(每粒含盐酸伪麻黄碱90mg和马来酸氯苯那敏4mg)在人体的生物等效性。方法于2006年6月采用随机交叉自身前后对照试验设计,26例受试者分别单次和多次空腹口服麻敏维C缓释胶囊(试验制剂)和复方盐酸伪麻黄碱缓释胶囊(参比制剂),与不同时间点取血样,采用液-质联用(HPLC/MS)法测定人血浆中盐酸伪麻黄碱和马来酸氯苯那敏的浓度,以DAS软件计算药物代谢动力学参数,并进行生物等效性评价。结果单次给药后,两组分的主要药物代谢动力学参数无统计学意义(P>0.05)。试验制剂中马来酸氯苯那敏和盐酸伪麻黄碱生物利用度分别为104.31%和109.19%。多次给药后,两组分的主要药物代谢动力学参数无统计学意义(P>0.05)。试验制剂的马来酸氯苯那敏和盐酸伪麻黄碱的生物利用度分别为103.58%和99.37%。结论麻敏维C缓释胶囊和复方盐酸伪麻黄碱缓释胶囊具有生物等效性。
Objective To evaluate the bioequivalence of Marivin C Sustained-Release Capsules (each containing 90 mg pseudoephedrine hydrochloride and 4 mg chlorphenamine maleate) in humans. Methods The randomized crossover self-control trial was designed in June 2006. Twenty-six subjects were treated with Mamin C Sustained-Release Capsule (Test Preparation) and Compound Pseudoephedrine Hydrochloride Sustained-Release Capsule (Reference Preparation ), And blood samples were taken at different time points. The concentrations of pseudoephedrine hydrochloride and chlorphenamine maleate in human plasma were determined by liquid chromatography-mass spectrometry (HPLC / MS), and the pharmacokinetic parameters were calculated by DAS software. Bioequivalence assessment. Results After the single administration, the main pharmacokinetic parameters of the two components had no statistical significance (P> 0.05). The bioavailability of chlorphenamine maleate and pseudoephedrine hydrochloride in the test preparation were 104.31% and 109.19% respectively. After multiple administrations, the main pharmacokinetic parameters of the two components were not statistically significant (P> 0.05). The bioavailability of chlorphenamine maleate maleate and pseudoephedrine hydrochloride were 103.58% and 99.37% respectively. Conclusion Ma Min Wei C sustained release capsules and pseudoephedrine hydrochloride sustained release capsules with bioequivalence.