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| 盐酸氟桂利嗪胶囊人体生物等效性研究 | |
| 引用本文： | 乔逸,彭洁,马忠英,林琳,文爱东.盐酸氟桂利嗪胶囊人体生物等效性研究[J].中国药师,2011,14(3):332-335. |
| 作者姓名： | 乔逸 彭洁 马忠英 林琳 文爱东 |
| 作者单位： | 1. 第四军医大学西京医院药剂科,西安,710033 2. 第四军医大学预防医学系 3. 解放军522医院药剂科 |
| 摘 要： | 目的:比较两种盐酸氟桂利嗪胶囊的人体生物等效性。方法:20名健康男性志愿者随机交叉单剂量口服盐酸氟桂利嗪胶囊（受试制剂）与盐酸氟桂利嗪胶囊（参比制剂）20 mg,采用LC-MS/MS法测定人血浆中氟桂利嗪浓度,用BAPP 2.2软件和DAS 2.1软件计算药动学参数和生物利用度。结果:口服盐酸氟桂利嗪受试制剂与参比制剂后的人体药动学参数分别为Cmax（73.34±10.87）和（70.54±10.27）ng·ml-1,tmax（4.2±1.2）和（3.8±1.1）h,t1/2β（6.1±1.4）和（6.4±1.8）h,AUCn～30（736.7±116.1）和（696.4±134.8）ng·h·ml-1,AUC0～∞（767.1±123.4）和（731.3±150.5）ng·h·ml-1。受试制剂的相对生物利用度为（107.2±13.3）%。受试制剂AUC0～30的90%置信区间在在参比制剂的等效范围内。结论:两种氟桂利嗪制剂生物利用度等效。 |
| 关 键 词： | 氟桂利嗪 药动学 生物等效性 高效液相色谱-质谱/质谱 |
Bioequivalence of Flunarizine Hydrochloride Capsules in Healthy Volunteers |
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| Qiao Yi,Peng Jie,Ma Zhongying,Lin Lin,Wen Aidong.Bioequivalence of Flunarizine Hydrochloride Capsules in Healthy Volunteers[J].China Pharmacist,2011,14(3):332-335. | |
| Authors: | Qiao Yi Peng Jie Ma Zhongying Lin Lin Wen Aidong |
| Institution: | QiaoYi~1,Peng Jie~2,Ma Zhongying~1,Lin Lin~3,Wen Aidong~1(1.Department of Pharmacy of Xijing Hospital,Fourth Military Medical University,Xi'an 710033,China,2.Department of Toxicology,Faculty of Preventive Medicine,3.Department of Pharmacy,522 Hospital of PLA) |
| Abstract: | Objective:To investigate the bioequivalence of two flunarizine preparations in healthy volunteers.Method:A total of 20 healthy male volunteers were enrolled in a randomized crossover study in which the subjects were randomly assigned to receive single dose of 20 mg flunarizine capsules(test preparation) or flunarizine capsules(reference preparation).Plasma concentrations of flunarizine were determined by LC-MS-MS.The pharmacokinetic parameters and bioequivalence were calculated with BAPP 2.2 and DAS 2.1 sof... |
| Keywords: | Flunarizine Pharmacokinetics Bioequivalence LC-MS/MS |
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