高效液相色谱荧光法测定血浆中左氧氟沙星的浓度及其生物等效性研究

杨小英; 张文萍; 王欣瑜; 党宏万

doi:10.3969/j.issn.1006-0111.2016.05.012

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高效液相色谱荧光法测定血浆中左氧氟沙星的浓度及其生物等效性研究

杨小英, 张文萍, 王欣瑜, 党宏万

文章导航 > 药学实践与服务 > 2016 > 34(5): 428-430,440

杨小英, 张文萍, 王欣瑜, 党宏万. 高效液相色谱荧光法测定血浆中左氧氟沙星的浓度及其生物等效性研究[J]. 药学实践与服务, 2016, 34(5): 428-430,440. doi: 10.3969/j.issn.1006-0111.2016.05.012

引用本文:

YANG Xiaoying, ZHANG Wenping, WANG Xinyu, DANG Hongwan. Determination of levofloxacin concentration in plasma of Chinese healthy volunteers by HPLC with fluorescence detection and bioequivalence study of levofloxacin hydrochloride tablets[J]. Journal of Pharmaceutical Practice and Service, 2016, 34(5): 428-430,440. doi: 10.3969/j.issn.1006-0111.2016.05.012

Citation:

YANG Xiaoying, ZHANG Wenping, WANG Xinyu, DANG Hongwan. Determination of levofloxacin concentration in plasma of Chinese healthy volunteers by HPLC with fluorescence detection and bioequivalence study of levofloxacin hydrochloride tablets[J]. Journal of Pharmaceutical Practice and Service, 2016, 34(5): 428-430,440. doi: 10.3969/j.issn.1006-0111.2016.05.012

高效液相色谱荧光法测定血浆中左氧氟沙星的浓度及其生物等效性研究

doi: 10.3969/j.issn.1006-0111.2016.05.012

宁夏医科大学总医院, 药剂科, 宁夏银川 750004;宁夏医科大学总医院, 临床药理研究室, 宁夏银川 750004

Determination of levofloxacin concentration in plasma of Chinese healthy volunteers by HPLC with fluorescence detection and bioequivalence study of levofloxacin hydrochloride tablets

General Hospital of Ningxia Medical University, Department of Pharmacy, Yinchuan 750004, China;General Hospital of Ningxia Medical University, Division of Clinical pharmacology, Yinchuan 750004, China

摘要: 目的建立高效液相色谱（HPLC）荧光法测定血浆中左氧氟沙星的浓度，研究盐酸左氧氟沙星片在健康人体中的生物等效性。方法采用随机交叉自身对照试验设计，24名健康男性受试者单次口服0.2 g盐酸左氧氟沙星片受试制剂或参比制剂，分别于不同时间点采集肘静脉血，采用HPLC荧光法测定血浆中左氧氟沙星的药物浓度。利用DAS 2.0软件计算药动学参数，评价两制剂的生物等效性。结果受试制剂与参比制剂的主要药动学参数t _1/2、t_max、ρ_max、AUC_0-36和 AUC_0-inf分别为（6.71±0.95）h和（6.60±1.00）h；（0.85±0.30）h 和（0.79±0.28）h ；（2 815.48±513.04）ng/ml和（3 185.59±674.29）ng/ml；（17 157.61±1 949.07）ng·h/ml和（17 425.06±2 447.80）ng·h/ml；（18 324.52±2 019.41）ng·h/ml和（18 540.41±2 523.08）ng·h/ml。两制剂主要药动学参数统计学分析无显著性差异。受试制剂与参比制剂 AUC_0-36、AUC_0-inf 和 ρ_max对数比值的 90%置信区间分别为95.2%~102.5%、96.1%~102.2%和82.8%~94.9%。结论受试制剂与参比制剂具有生物等效性，为生物等效制剂。
- 左氧氟沙星 /
- 高效液相色谱 /
- 生物等效性
Abstract: Objective To develop a HPLC-fluorescence method to determine levofloxacin concentration in plasma for studying bioequivalence of levofloxacin hydrochloride tablet in Chinese healthy volunteers. Methods A single-dose of 0.2 g test or reference preparation was given to 24 healthy volunteers in a randomized crossover study. The concentrations of levofloxacin at different time points were determined by HPLC with fluorescence detection. The pharmacokinetic parameters were calculated using DAS 2.0 software program. Results The main pharmacokinetic parameters of the test and reference preparation,t _1/2、t_max、ρ_max、AUC_0-36 and AUC_0-inf, were respectively (6.71±0.95) h and (6.60±1.00) h,(0.85±0.30) h and (0.79±0.28) h,(2 815.48±513.04) ng/ml and (3 185.59±674.29) ng/ml,(17 157.61±1 949.07) ng·h/ml and (17 425.06±2 447.80) ng·h/ml,(18 324.52±2 019.41) ng·h/ml and (18 540.41±2 523.08) ng·h/ml. The statistical analysis showed that the main pharmacokinetic parameters between test and reference preparations were no significant differences. The 90% confidence interval of test and reference preparations AUC_0-36、AUC_0-inf and ρ_max were 95.2%~102.5%、96.1%~102.2% and 82.8%~94.9%. Conclusion The test and reference preparations were bioequivalent.
- levofloxacin /
- HPLC /
- bioequivalence

[1]	郭小瑞,毕开顺,陈晓辉.盐酸左氧氟沙星胶囊的人体生物等效性研究[J]. 中国现代应用药学杂志,2007,24(2):130-132.
[2]	Zhou ZL, Yang M, Yu XY, et al. A rapid and simple high-performance liquid chromatography method for the determination of human plasma levofloxacin concentration andits application to bioequivalence studies[J].Biomed Chromatogr,2007,21(10):1045-1051.
[3]	钱妍,赵春景,张桂蓉,等.盐酸左氧氟沙星胶囊的人体生物等效性研究 [J].重庆医科大学学报,2007,32(1):59-62.
[4]	谢林利,陈勇川,唐敏,等. 盐酸左氧氟沙星片生物等效性研究[J]. 中国药业,2009,18(16):22-24.

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高效液相色谱荧光法测定血浆中左氧氟沙星的浓度及其生物等效性研究

doi: 10.3969/j.issn.1006-0111.2016.05.012

宁夏医科大学总医院, 药剂科, 宁夏银川 750004;宁夏医科大学总医院, 临床药理研究室, 宁夏银川 750004

收稿日期: 2015-02-26
修回日期: 2015-06-10

关键词:

左氧氟沙星 /

高效液相色谱 /

生物等效性

摘要: 目的建立高效液相色谱（HPLC）荧光法测定血浆中左氧氟沙星的浓度，研究盐酸左氧氟沙星片在健康人体中的生物等效性。方法采用随机交叉自身对照试验设计，24名健康男性受试者单次口服0.2 g盐酸左氧氟沙星片受试制剂或参比制剂，分别于不同时间点采集肘静脉血，采用HPLC荧光法测定血浆中左氧氟沙星的药物浓度。利用DAS 2.0软件计算药动学参数，评价两制剂的生物等效性。结果受试制剂与参比制剂的主要药动学参数t _1/2、t_max、ρ_max、AUC_0-36和 AUC_0-inf分别为（6.71±0.95）h和（6.60±1.00）h；（0.85±0.30）h 和（0.79±0.28）h ；（2 815.48±513.04）ng/ml和（3 185.59±674.29）ng/ml；（17 157.61±1 949.07）ng·h/ml和（17 425.06±2 447.80）ng·h/ml；（18 324.52±2 019.41）ng·h/ml和（18 540.41±2 523.08）ng·h/ml。两制剂主要药动学参数统计学分析无显著性差异。受试制剂与参比制剂 AUC_0-36、AUC_0-inf 和 ρ_max对数比值的 90%置信区间分别为95.2%~102.5%、96.1%~102.2%和82.8%~94.9%。结论受试制剂与参比制剂具有生物等效性，为生物等效制剂。

English Abstract

Determination of levofloxacin concentration in plasma of Chinese healthy volunteers by HPLC with fluorescence detection and bioequivalence study of levofloxacin hydrochloride tablets

General Hospital of Ningxia Medical University, Department of Pharmacy, Yinchuan 750004, China;General Hospital of Ningxia Medical University, Division of Clinical pharmacology, Yinchuan 750004, China

Received Date: 2015-02-26
Rev Recd Date: 2015-06-10

Keywords:

levofloxacin /
HPLC /
bioequivalence

Abstract: Objective To develop a HPLC-fluorescence method to determine levofloxacin concentration in plasma for studying bioequivalence of levofloxacin hydrochloride tablet in Chinese healthy volunteers. Methods A single-dose of 0.2 g test or reference preparation was given to 24 healthy volunteers in a randomized crossover study. The concentrations of levofloxacin at different time points were determined by HPLC with fluorescence detection. The pharmacokinetic parameters were calculated using DAS 2.0 software program. Results The main pharmacokinetic parameters of the test and reference preparation,t _1/2、t_max、ρ_max、AUC_0-36 and AUC_0-inf, were respectively (6.71±0.95) h and (6.60±1.00) h,(0.85±0.30) h and (0.79±0.28) h,(2 815.48±513.04) ng/ml and (3 185.59±674.29) ng/ml,(17 157.61±1 949.07) ng·h/ml and (17 425.06±2 447.80) ng·h/ml,(18 324.52±2 019.41) ng·h/ml and (18 540.41±2 523.08) ng·h/ml. The statistical analysis showed that the main pharmacokinetic parameters between test and reference preparations were no significant differences. The 90% confidence interval of test and reference preparations AUC_0-36、AUC_0-inf and ρ_max were 95.2%~102.5%、96.1%~102.2% and 82.8%~94.9%. Conclusion The test and reference preparations were bioequivalent.

引用本文:

Citation:

YANG Xiaoying, ZHANG Wenping, WANG Xinyu, DANG Hongwan. Determination of levofloxacin concentration in plasma of Chinese healthy volunteers by HPLC with fluorescence detection and bioequivalence study of levofloxacin hydrochloride tablets[J]. Journal of Pharmaceutical Practice and Service, 2016, 34(5): 428-430,440. doi: 10.3969/j.issn.1006-0111.2016.05.012