【摘要】 目的 评价麻敏维C缓释胶囊（每粒含盐酸伪麻黄碱90 mg和马来酸氯苯那敏4 mg）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 gt;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 gt;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。
【Abstract】 Objective To investigate the bioequivalence of delayed-release capsule of ephedrine-chlorphenamine-vitamin C. Methods In June 2006, 26 healthy volunteers were administrated with delayed-release capsule of ephedrine-chlorphenamine-vitamin C or delayed-release capsule of ephedrine-chlorphenamine in a randomized and two-way crossover design with single or multiple dosage. The plasma concentrations were determined by HPLC/MS method. The pharmacokinetic parameters and bioequivalence were calculated by DAS software. Results After single dose administration, no significant differences were found in tmax, Cmax, t1/2, and AUC0-t between the two preparations. The relative bioavailability of the test preparation was 104.31% in chlorphenamine and 109.19% in ephedrine, respectively. After multiple dose administration, no significant differences were found in tmax, Cmax, t1/2, and AUC0-t between the two preparations. The relative bioavailability of the test preparation was 103.58% in chlorphenamine and 99.37% in ephedrine, respectively. Conclusion Delayed-release capsule of ephedrine-chlophenamine-vitamin C is equivalent to the reference preparation.
Citation：
SHEN Qi,LIANG Maozhi,LIU Chuntao,YU Qin,LUO Zhu,NAN Feng,WU Songze,QIN Yongping,XU Nan,ZHENG Li,FENG Ping,WANG Ying. Bioequivalence of Delayed-release Capsule of Ephedrine-Chlorphenamine-Vitamin C in Healthy Volunteers. West China Medical Journal, 2010, 25(12): 2225-2227. doi:
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- 1. Jawad SSM, Eccles R. Effect of pseudoephedrine on nasal airflow in patients with nasal congestion associated with common cold[J]. Rhinology, 1998, 36: 73-76.
- 2. Taverner D, Danz C, Economos D. The effects of oral pseudoephedrine on nasal patency in the common cold: a double-blind single-dose placebo controlled trial[J]. Clin Otolaryngol, 1999, 24: 47-51.
- 3. 黄凤英, 刘善军, 刘丙桂. 液相色谱-串联质谱法测定人血浆中伪麻黄碱及其药动学研究[J]. 中南药学, 2009, 7(11): 835-840.
- 4. 谢敏, 贾琳静, 郜娜, 等. 高效液相色谱法测定人体内氯苯那敏血药浓度及药动学研究[J]. 中国医院药学杂志, 2006, 26(10): 1205-1207.
- 5. 冯怡, 黄羽, 赖伟玲, 等. LC/MS/MS法测定兔血浆中的盐酸伪麻黄碱及美敏伪麻溶液的药动学研究[J]. 广东药学院学报, 2008, 24, (6): 572-574.
- 6. 乔海灵, 田鑫, 郭玉忠, 等. 马来酸氯苯那敏片健康人体药动学和相对生物利用度研究[J]. 中国临床药理学及治疗学, 2005, 10(12): 1416-1419.
- 7. 毛金银, 丁黎, 徐贵丽, 等. 西嗪伪麻缓释片人体药动学研究[J]. 中国医疗前沿, 2007, 15: 1168-1174.
- 8. 邹建军, 谷祥富, 朱余兵, 等. 健康受试者口服西嗪伪麻缓释片后伪麻黄碱的药动学[J]. 中国医院药学杂志, 2007, 27(7): 888-891.
- 9. 李悦, 朱运贵. 复方伪麻普生缓释片的人体药物动力学及相对生物利用度研究[J]. 实用临床药学杂志, 2006, 10(3): 81-84.
- 10. 赵红光, 张一飞, 于景翠, 等. 盐酸伪麻黄碱缓释片的人体药动学及生物等效性研究[J]. 中国医院药学杂志, 2006, 26(6): 179-181.
- 11. 钟明康, 施孝金, 等. 盐酸伪麻黄碱缓释片在健康志愿者中的药动学研究[J]. 中国医院药学杂志, 2001, 21(7): 395-397.
