液相色谱-质谱／质谱联用法测定苯唑西林浓度及其胶囊剂人体生物等效性的研究
目的：建立液相色谱-质谱／质谱联用法（ LC-MS／MS）测定人血浆中苯唑西林的浓度，研究苯唑西林钠胶囊与参比制剂苯唑西林钠胶囊（奇菲）的生物等效性。方法：采用随机、单剂量、双交叉对照试验设计，20名男性健康志愿者空腹口服受试及参比制剂1000 mg，采用蛋白沉淀法处理血浆样品，使用LC-MS／MS法测定血浆中苯唑西林的浓度，并以DAS 2.0软件进行方差分析及双单侧t检验，判断2种制剂是否具有生物等效性。结果：口服受试及参比制剂后，血浆中苯唑西林峰浓度（Cmax）分别为（17.0±2.77）、（15.5±3.46）μg／ml；达峰时间（tmax）分别为（0.63±0.14）、（0.72±0....
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| Published in | 中国医院用药评价与分析 no. 5; pp. 597 - 600 |
|---|---|
| Main Author | |
| Format | Journal Article |
| Language | Chinese |
| Published |
河北医科大学第二医院药学部,河北石家庄,050000%石药集团中奇制药技术 石家庄 有限公司,河北石家庄,050051
2015
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| Subjects | |
| Online Access | Get full text |
| ISSN | 1672-2124 |
| DOI | 10.14009/j.issn.1672-2124.2015.05.014 |
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| Abstract | 目的：建立液相色谱-质谱／质谱联用法（ LC-MS／MS）测定人血浆中苯唑西林的浓度，研究苯唑西林钠胶囊与参比制剂苯唑西林钠胶囊（奇菲）的生物等效性。方法：采用随机、单剂量、双交叉对照试验设计，20名男性健康志愿者空腹口服受试及参比制剂1000 mg，采用蛋白沉淀法处理血浆样品，使用LC-MS／MS法测定血浆中苯唑西林的浓度，并以DAS 2.0软件进行方差分析及双单侧t检验，判断2种制剂是否具有生物等效性。结果：口服受试及参比制剂后，血浆中苯唑西林峰浓度（Cmax）分别为（17.0±2.77）、（15.5±3.46）μg／ml；达峰时间（tmax）分别为（0.63±0.14）、（0.72±0.26）h；药时曲线下面积（AUC0～6 h）分别为（22.52±4.38）、（22.54±5.79）μg／（ml· h）；受试制剂的相对生物利用度为（102.8±19.3）％。结论：受试制剂与市售参比制剂具有生物等效性。 |
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| AbstractList | 目的：建立液相色谱-质谱／质谱联用法（ LC-MS／MS）测定人血浆中苯唑西林的浓度，研究苯唑西林钠胶囊与参比制剂苯唑西林钠胶囊（奇菲）的生物等效性。方法：采用随机、单剂量、双交叉对照试验设计，20名男性健康志愿者空腹口服受试及参比制剂1000 mg，采用蛋白沉淀法处理血浆样品，使用LC-MS／MS法测定血浆中苯唑西林的浓度，并以DAS 2.0软件进行方差分析及双单侧t检验，判断2种制剂是否具有生物等效性。结果：口服受试及参比制剂后，血浆中苯唑西林峰浓度（Cmax）分别为（17.0±2.77）、（15.5±3.46）μg／ml；达峰时间（tmax）分别为（0.63±0.14）、（0.72±0.26）h；药时曲线下面积（AUC0～6 h）分别为（22.52±4.38）、（22.54±5.79）μg／（ml· h）；受试制剂的相对生物利用度为（102.8±19.3）％。结论：受试制剂与市售参比制剂具有生物等效性。 R965; 目的：建立液相色谱-质谱／质谱联用法（ LC-MS／MS）测定人血浆中苯唑西林的浓度，研究苯唑西林钠胶囊与参比制剂苯唑西林钠胶囊（奇菲）的生物等效性。方法：采用随机、单剂量、双交叉对照试验设计，20名男性健康志愿者空腹口服受试及参比制剂1000 mg，采用蛋白沉淀法处理血浆样品，使用LC-MS／MS法测定血浆中苯唑西林的浓度，并以DAS 2.0软件进行方差分析及双单侧t检验，判断2种制剂是否具有生物等效性。结果：口服受试及参比制剂后，血浆中苯唑西林峰浓度（Cmax）分别为（17.0±2.77）、（15.5±3.46）μg／ml；达峰时间（tmax）分别为（0.63±0.14）、（0.72±0.26）h；药时曲线下面积（AUC0～6 h）分别为（22.52±4.38）、（22.54±5.79）μg／（ml· h）；受试制剂的相对生物利用度为（102.8±19.3）％。结论：受试制剂与市售参比制剂具有生物等效性。 |
| Abstract_FL | OBJECTIVE:To determine human plasma concentration of oxacillin by liquid chromatography -mass spectrometry ( LC-MS/MS ) and study the bioequivalence of the tested and the standard preparations of oxacillin sodium capsules.METHODS:In a randomized, single dose and double crossover design, 20 healthy male volunteers were administered orally with tested and reference oxcillin sodium capsules ( 1 000 mg ) .The plasma samples were treated by of protein precipitation method, and the plasma concentrations of oxacillin within 6 hours after administration were determined by LC-MS/MS;DAS 2.0 software was employed for analysis of variance and two one-sided t-test for evaluation of the bioequivalence of the two preparations.RESULTS: After oral administration of the tested vs. reference preparations, peak plasma concentration (Cmax) of oxacillin stood at (17.0 ±2.77) vs.(15.5 ±3.46) μg/ml, with tmax of (0.63 ±0.14) vs.(0.72 ±0.26) h, and area under the concentration-time curve (AUC0-6 h) of (22.52 ±4.38) vs.(22.54 ±5.79) μg/(ml· h).The relative bioavailability of the tested preparation was (102.8 ± 19.3)%.CONCLUSIONS:The tested oxacillin sodium capsules and the reference preparation are bioequivalent. |
| Author | 任进民 王川平 赵曦 董劼 朱辉梅 |
| AuthorAffiliation | 河北医科大学第二医院药学部,河北石家庄050000 石药集团中奇制药技术石家庄有限公司,河北石家庄050051 |
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| Author_FL | ZHAO Xi DONG Jie REN Jinmin ZHU Huimei WANG Chuanping |
| Author_FL_xml | – sequence: 1 fullname: REN Jinmin – sequence: 2 fullname: WANG Chuanping – sequence: 3 fullname: ZHAO Xi – sequence: 4 fullname: DONG Jie – sequence: 5 fullname: ZHU Huimei |
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| DocumentTitleAlternate | Determiniation of Oxacillin Concentration in Healthy Volunteers by LC-MS/MS and Bioequivalence Study of Oxacillin Capsules in Human Body |
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| Keywords | LC-MS/MS Oxacillin Bioequivalence 液相色谱-质谱/质谱联用法 生物等效性 苯唑西林 |
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| Notes | Oxacillin;LC-MS/MS;Bioequivalence REN Jinmin, WANG Chuanping, ZHAO Xi, DONG Jie, ZHU Huimei （ 1. Dept. of Pharmacy, The Second Hospital of Hebei Medical Unversity, Hebei Shijiazhuang 050000, China; 2. Zhongqi Pharmaceutical Technology （Shijiazhuang） Co. Ltd. of Shijiazhuang Pharmaceutical Group, Hebei Shijiazhuang 050051, China） OBJECTIVE：To determine human plasma concentration of oxacillin by liquid chromatography -mass spectrometry （ LC-MS/MS ） and study the bioequivalence of the tested and the standard preparations of oxacillin sodium capsules.METHODS：In a randomized, single dose and double crossover design, 20 healthy male volunteers were administered orally with tested and reference oxcillin sodium capsules （ 1 000 mg ） .The plasma samples were treated by of protein precipitation method, and the plasma concentrations of oxacillin within 6 hours after administration were determined by LC-MS/MS;DAS 2.0 software was employed for analysis of variance and two one-sided t-test for＆amp;nbsp;evaluation of the bioe |
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| PublicationTitle | 中国医院用药评价与分析 |
| PublicationTitleAlternate | Evaluation and Analysis of Drug-use in Hospitals of China |
| PublicationTitle_FL | Evaluation and Analysis of Drug-Use in Hospitals of China |
| PublicationYear | 2015 |
| Publisher | 河北医科大学第二医院药学部,河北石家庄,050000%石药集团中奇制药技术 石家庄 有限公司,河北石家庄,050051 |
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| Snippet | 目的：建立液相色谱-质谱／质谱联用法（ LC-MS／MS）测定人血浆中苯唑西林的浓度，研究苯唑西林钠胶囊与参比制剂苯唑西林钠胶囊（奇菲）的生物等效性。方法：采用随机、单剂量、双交叉对照试验设计，20名男性健康志愿者空腹口服受试及参比制剂1000... R965; 目的：建立液相色谱-质谱／质谱联用法（ LC-MS／MS）测定人血浆中苯唑西林的浓度，研究苯唑西林钠胶囊与参比制剂苯唑西林钠胶囊（奇菲）的生物等效性。方法：采用随机、单剂量、双交叉对照试验设计，20名男性健康志愿者空腹口服受试及参比制剂1000... |
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| SubjectTerms | 液相色谱-质谱/质谱联用法 生物等效性 苯唑西林 |
| Title | 液相色谱-质谱／质谱联用法测定苯唑西林浓度及其胶囊剂人体生物等效性的研究 |
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