替硝唑片在中国健康受试者中的生物等效性研究  

Bioequivalence of tinidazole tablets in Chinese healthy volunteers

作　　者：杨雅茹[1] 戴秀璟 郑凌[2] 陈璐璐[1] 陶春蕾 许杨 胡伟[1] YANG Ya-ru;DAI Xiu-jing;ZHENG Ling;CHEN Lu-lu;TAO Chun-lei;XU Yang;HU Wei(a.Department of Pharmacy;b.Department of Respiratory,lhe Second A~liated Hospital of Anhui Medical University,Hefei 230601,China;2.Ardmi Wanbang Medical Technology Company Limited,Hefei 230601,China)

机构地区：[1]安徽医科大学第二附属医院药学部 [2]安徽医科大学第二附属医院呼吸内科 [3]安徽万邦医药科技有限公司

出　　处：《中国临床药理学杂志》2018年第18期2151-2154,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价2种替硝唑片在中国成年健康受试者中的生物等效性。方法将24例成年健康受试者随机分为2组,试验用自身交叉对照设计,餐后口服单剂量替硝唑片500 mg。用高效液相色谱串联质谱(HPLC-MS/MS)法测定血浆中替硝唑的浓度,用DAS2.1.1软件按非房室模型计算药代动力学参数,并进行生物等效性评价。结果替硝唑受试制剂和参比制剂的主要药代动力学参数:t_(max)分别为(2.37±1.46),(2.28±1.09)h;C_(max)分别为(13.21±2.28),(13.38±1.96)μg·mL^(-1);AUC_(0-t)分别为(272.38±39.86),(266.70±42.78)μg·mL^(-1)·h;AUC_(0-∞)分别为(282.64±42.49),(280.10±38.40)μg·mL^(-1)·h;t_(1/2)分别为(14.88±1.71),(14.95±1.52)h,以AUC_(0-72h)计算2种制剂的相对生物利用度为(99.6±7.6)%。结论 2种替硝唑片在中国健康受试者体内具有生物等效性。Objective To evaluate the bioequivalence of two tinidazole tablets in Chinese healthy volunteers. Methods A single oral dose 500 mg of test and reference tinidazole tablets were given to 24 subjects according to an open randomized crossover design. The concentration of tinidazole in plasma were determined by high performance liquid chromatography tandem mass spectrometry. The pharmacokineric parameters were calculated and the bioequivalence was compared by non-compartment model of DAS 2. 1. 1. Results The main pharmacokinetic parameters of tinidazole test preparation and reference preparation were calculated. tmax were（ 2. 37 ± 1. 46）,（ 2. 28 ± 1. 09） h; Cmax were（ 13. 21 ± 2. 28）,（ 13. 38 ± 1. 96） μg · mL-1; AUC0-t were（ 272. 38 ± 39. 86）,（ 266. 70 ± 42. 78） μg·mL-1·h; AUC（0-∞） were（ 282. 64 ± 42. 49）,（ 280. 10 ± 38. 40） μg · mL-1· h; t（1/2） were（ 14. 88 ± 1. 71）,（ 14. 95 ± 1. 52） h,respectively. The relative bioavailability of tinidazole test preparation to reference formulation was（ 99. 6 ± 7. 6） % with AUC0-72 h. Conclusion The two tinidazole tablets were bioequivalent in Chinese healthy volunteers.

关 键 词：替硝唑片 生物利用度 生物等效性 

分 类 号：R978[医药卫生—药品]