Study on bioequivalence of sodium folinate injection in healthy volunteers

	Study on bioequivalence of sodium folinate injection in healthy volunteers
	Cheng Chunyan 1; Li Zhen 1; Zhang Yifan2 ; Sun Qinying 3; Lu Jianping 4
刊名	Pharmaceutical Care and Research
	2014
卷号	14 期号:1 页码:27-30
关键词	sodium folinate calcium folinate bioequivalence chromatography,liquid tandem mass spectrometry
ISSN号	1671-2838
其他题名	亚叶酸钠注射液的健康人体生物等效性研究
文献子类	Article
英文摘要	Objective:To study the pharmacokinetics of sodium folinate injection in healthy volunteers and to make a comparision of the bioequivalence between sodium folinate and calcium folinate injections.Methods:Twenty healthy male volunteers were enrolled in the study.Test preparation sodium folinate 200mg/m~2 (folinic acid count)or reference preparation calcium folinate 200mg/m~2 (folinic acid count)were given respectively to the volunteers according to randomized two-way cross-over study design.The washout time was 7days.The plasma concentrations of 6R-folinic acid,6S-folinic acid and 5-methyl-tetrahydrofolic acid were determined by LC-MS/MS method.Results:The main pharmacokinetic parameters of test and control preparations for 6R-folinic acid,6S-folinic acid and 5-methyl-tetrahydrofolic acid were as follows:c_(max) (19.72.21),(20.22.77)mug/ml,(6.081.12),(6.601.07)mug/ml,(2.430.437),(2.500.409)mug/ml;t_(max) (2.150.249),(2.150.348)h, (1.800.288),(1.850.235)h,(3.180.563),(3.300.441)h;t1/2(9.341.99),(8.761.04)h,(1.500.583), (1.360.358)h,(5.810.682),(5.690.773)h;AUC_(last) (17916.1),(17620.8)mug·h·ml~(-1),(15.01.76),(15.6 1.66)mug·h·ml~(-1),(19.73.88),(20.33.93)mug·h·ml~(-1);AUC_(inf)(21525.9),(20827.2)mug·h·ml~(-1),(15.6 1.88),(16.11.65)mug·h·ml~(-1), (20.94.10),(21.54.16)mug·h·ml~(-1). The AUC_(last) and c_(max) after logarithmic transform of 3main constituents of both forms were compared by variance analysis.The 90%confidence interval of AUClastwere all within 80%-125%range.The 90%confidence interval of c_(max) were all in 75%-133%range.The nonparametric test showed the t_(max) had no significant difference between two formulations(P>0.05).Conclusion:The two preparations were bioequivalent.
WOS研究方向	Pharmacology & Pharmacy (provided by Clarivate Analytics)
语种	中文
CSCD记录号	CSCD:5096629
内容类型	期刊论文
源URL	[http://119.78.100.183/handle/2S10ELR8/269298]
专题	中国科学院上海药物研究所
作者单位	1.Department of Pharmacy,Changhai Hospital,Second Military Medical University, Shanghai 200433, China.; 2.Center for Drug Metabolism and Pharmacokinetics Research,Institute of Materia Medica of Shanghai,Chinese Academy of Sciences, Shanghai 201203, China.; 3.Department of Respiration Disease,Changhai Hospital,Second Military Medical University, Shanghai 200433, China.; 4.Department of Gastroenterology,Changhai Hospital,Second Military Medical University, Shanghai 200433, China.
推荐引用方式 GB/T 7714	Cheng Chunyan,Li Zhen,Zhang Yifan,et al. Study on bioequivalence of sodium folinate injection in healthy volunteers[J]. Pharmaceutical Care and Research,2014,14(1):27-30.
APA	Cheng Chunyan,Li Zhen,Zhang Yifan,Sun Qinying,&Lu Jianping.(2014).Study on bioequivalence of sodium folinate injection in healthy volunteers.Pharmaceutical Care and Research,14(1),27-30.
MLA	Cheng Chunyan,et al."Study on bioequivalence of sodium folinate injection in healthy volunteers".Pharmaceutical Care and Research 14.1(2014):27-30.