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浅谈盐酸伐昔洛韦片在健康人体的药代动力学和相对生物利用度-外_外科学论文

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简介作者摘要:胡晓,张红,夏春华,陈月江【盐酸伐昔洛韦片;阿昔洛韦;色谱法,高压液相;药代动力学;生物利用度Pharmacokineticsandrelativebioavaila

作者摘要:胡晓 ,张红  ,夏春华  ,陈月江

【 盐酸伐昔洛韦片;阿昔洛韦;色谱法,高压液相;药代动力学;生物利用度

  Pharmacokinetics and relative bioavailability of valaciclovir hydrochloride tablets in Chinese healthy volunteers

  【Abstract AIM摘要: To study the pharmacokinetics and relative bioavailability of valaciclovir hydrochloride tablets and evaluate its bioequivalence. METHODS摘要: A single oral dose 600 mg of 2 valaciclovir hydrochloride tablets was given to 18 healthy volunteers in an open randomized crossover study. The concentration of acyclovir in plasma was determined by HPLC at different time points within 14 h following administration. The pharmacokinetic parameters were calculated by BAPP 2.0 software and the bioequivalence was evaluated by two onesided t test and 90%confidence intervals. RESULTS摘要: The calibration curve of acyclovir was linear in the range of 0.1~4.0 μg/mL (r=0.9999), and an intraday and interday RSD of<7.00% was observed. The concentrationtime curve after administration was best fitted to a one compartment open model, and main pharmacokinetic parameters were as follows摘要: Tmax were (1.50±0.40) and (1.40±0.40) h; Cmax were (2.70±0.68) and (2.87±0.75) μg/mL; t1/2 were (3.00±0.65) and (3.28±0.67) h; AUC0-14 were 9.07±2.43 and 9.71±2.70 μg・h/mL. The relative bioavailability of the test preparations compared with the reference preparations was (96.4±23.7)%. There was no statistically singnificant difference in parameters Tmax, t1/2, Cmax, MRT, AUC0-14 and AUC0-∞ between the 2 products (P>0.05). CONCLUSION摘要: The 2 valaciclovir hydrochloride tablets were bioequivalent.

  【Keywords valaciclovir hydrochloride tablet; acyclovir; chromatography, high pressure liquid; pharmacokinetics; biological availability

  【摘要 目的摘要: 探究盐酸伐昔洛韦片在健康人体的药代动力学和相对生物利用度  ,为临床公道用药提供依据. 方法摘要: 采用双周期、单中心、开放、自身交叉对照的探究方法 ,18例健康志愿者随机分为两组  ,单次,交叉口服盐酸伐昔洛韦片600 mg后  ,以HPLC法测定血浆中阿昔洛韦的浓度 ,采用BAPP2.0软件进行数据处理  ,计算药代动力学参数. 结果摘要: HPLC法测定阿昔洛韦的线性范围为0.1~4.0 μg/mL(r=0.9999) ,日内和日间RSD均小于7.00%. 试验和参比制剂的药时曲线可用一室模型拟合  ,两者主要药代动力学参数Tmax分别为(1.50±0.40)  ,(1.40±0.40) h; Cmax分别为(2.70±0.68) ,(2.87±0.75) μg/mL. t1/2分别为(3.00±0.65) ,(3.28±0.67) h;AUC0-14分别为(9.07±2.43)  ,(9.71±2.70) μg・h/mL. 两种盐酸伐昔洛韦片主要药动学参数间均无明显性差异(P>0.05). 供试制剂对参比制剂的相对生物利用度为 (96.4±23.7)%. 结论摘要: 供试制剂和参比制剂具有生物等效性.

  【 盐酸伐昔洛韦片;阿昔洛韦;色谱法  ,高压液相;药代动力学;生物利用度

  0引言

  盐酸伐昔洛韦(valaciclovir hydrochloride)是阿昔洛韦(acyclovir)的L缬氨酸酯盐酸盐 ,为阿昔洛韦的前体药物 ,口服后在体内迅速转化为阿昔洛韦而发挥抗病毒功能. 和阿昔洛韦相比  ,盐酸伐昔洛韦具有水溶性好  ,口服吸收迅速  ,生物利用度高  ,血浆半衰期长等药代动力学特征. 在临床上用于水痘  ,带状疱疹及Ⅰ型,Ⅱ型单纯疱疹病毒感染  ,包括初发和复发的生殖器疱疹病毒感染的治疗  ,具有起效快  ,疗效好  ,用药量小 ,服药次数少 ,疗程短 ,不良反应少等优点[1-3]. 本探究对国内两厂家生产的盐酸伐昔洛韦片进行了药代动力学和生物等效性评价  ,旨在为临床公道用药提供依据.
     

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