| 司帕沙星片剂在健康人体的药动学和相对生物利用度 |
| 投稿时间：2012-02-27 修订日期：2012-05-02 点此下载全文 |
| 引用本文：隋淼,王晓波,袭荣刚,孙佳丹.司帕沙星片剂在健康人体的药动学和相对生物利用度[J].药学实践杂志,2012,30(5):372~375 |
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| 中文摘要:目的 建立测定血浆中司帕沙星的HPLC内标法并研究司帕沙星片的相对生物利用度及生物等效性。方法 20名健康志愿者分两组,随机、交叉口服受试制剂与参比制剂的司帕沙星片0.4 g,HPLC法测定血药浓度,计算药动学参数及生物等效性评价。结果 受试制剂与参比制剂血浆中司帕沙星的tmax为(4.68±0.44)和(4.55±0.51)h;Cmax为(1 560.4±243.9)和(1 584.1±273.9)ng/ml;t1/2为(20.92±4.85)和 (19.81±3.75)h;用梯形法计算AUC0-t为(43 325±12 174)和(44 139±11 815)ng·h/ml;AUC0-∞为(45 452±12 884)和(45 999±12 629)ng·h/ml。以AUC0-t计算,受试制剂的平均相对生物利用度为(97.9±5.8)%。结论 两制剂具有生物等效性。 |
| 中文关键词:帕沙星 生物利用度 生物等效性 高效液相色谱法 |
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| Pharmacokinetics and relative bioavailability of Sparfloxacin in healthy volunteer |
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| Abstract:Objective To determine Sparfloxacin concentrations in human plasma and study the pharmacokinetics and relative bioavailability of Sparfloxacin for Suspension. Methods A single dose reference and test was given to 20 healthy volunteers in a randomized 2-way cross-over study. The plasma Sparfloxacin concentrations were determined by HPLC. The pharmacokinetics as well as relative bioavailability was measured. Results The main pharmacokinetic parameters of two formulations, Sparfloxacin in test and reference drug were as follows:tmax were (4.68±0.44)and(4.55±0.51)h;Cmax were(1 560.4±243.9)and(1 584.1±273.9)ng/ml;t1/2 were(20.92±4.85)and (19.81±3.75)h;AUC0-t were (43 325±12 174)and(44 139±11 815)ng·h/ml;AUC0-∞ were(45 452±12 884)and(45 999±12 629)ng·h/ml respectively. Using DASS program, the results of variance and two one-sided t-test statistical analyses for Ln Cmax. Two formulations were bioequivalent. Conclusion The reference and test Sparfloxacin were bioequivalent. |
| keywords:Sparfloxacin bioavailability bioequivalence HPLC |
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