Troubleshooting of bioinequivalence of compound valsartan tablets

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	Troubleshooting of bioinequivalence of compound valsartan tablets
	Shao Da 2; Zhang Yifan1 ; Zhan Yan1 ; Chen Xiaoyan1 ; Zhong Dafang2
刊名	Acta Pharmaceutica Sinica
	2014
卷号	49 期号:4 页码:524-529
关键词	valsartan hydrochlorothiazide bioequivalence bioinequivalence
ISSN号	0513-4870
其他题名	复方缬沙坦片生物不等效性原因分析
文献子类	Article
英文摘要	The study aims to evaluate the bioequivalence of valsartan hydrochlorothiazide tablets, and to investigate the potential cause of bioinequivalence. This was a single-center study with an open, randomized double-way crossover design. Test and reference preparations containing 160 mg of valsartan and 25 mg of hydrochlorothiazide were given to 36 healthy male volunteers. Plasma concentrations of valsartan and hydrochlorothiazide were determined simultaneously by LC-MS/MS. The pharmacokinetic parameters and relative bioavailability were calculated, while the bioequivalence between test and reference preparations were evaluated. The dissolution profiles of test and reference preparations in four different mediums were determined via dissolution test and HPLC. The similarity was investigated according to the similarity factors (f_2). The F_(0?t) and F_(0?) were (139.465.2) % and (137.561.2) % for valsartan of test preparations. It led to get the conclusion that test and reference preparations were not bioequivalent for valsartan. A significant difference was observed between test and reference tablets in the valsartan dissolution test of pH 1.2 hydrochloric acid solution. The key factor of the bioinequivalence might be that dissolution of valsartan in acid medium has marked difference between two preparations.
WOS研究方向	Pharmacology & Pharmacy (provided by Clarivate Analytics)
语种	中文
CSCD记录号	CSCD:5103285
内容类型	期刊论文
源URL	[http://119.78.100.183/handle/2S10ELR8/269342]
专题	上海药物代谢研究中心
通讯作者	Zhong Dafang
作者单位	1.Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China. 2.College of Pharmacy, Soochow University, Suzhou, Jiangsu 215123, China.;
推荐引用方式 GB/T 7714	Shao Da,Zhang Yifan,Zhan Yan,et al. Troubleshooting of bioinequivalence of compound valsartan tablets[J]. Acta Pharmaceutica Sinica,2014,49(4):524-529.
APA	Shao Da,Zhang Yifan,Zhan Yan,Chen Xiaoyan,&Zhong Dafang.(2014).Troubleshooting of bioinequivalence of compound valsartan tablets.Acta Pharmaceutica Sinica,49(4),524-529.
MLA	Shao Da,et al."Troubleshooting of bioinequivalence of compound valsartan tablets".Acta Pharmaceutica Sinica 49.4(2014):524-529.