硫普罗宁片人体药动学及生物等效性研究

王晓波; 袭荣刚; 刘丹; 程申强; 谢小青; 关屹; 刘洋

引用本文:	王晓波,袭荣刚,刘丹,程申强,谢小青,关屹,刘洋.硫普罗宁片人体药动学及生物等效性研究[J].中国现代应用药学,2011,28(4):368-372.
	WANG Xiaobo,XI Ronggang,LIU Dan,CHENG Shenqiang,XIE Xiaoqing,GUAN Yi,LIU Yang.Pharmacokinetics and Bioequivalence of Two Tiopronin Preparations in Healthy Volunteers[J].Chin J Mod Appl Pharm(中国现代应用药学),2011,28(4):368-372.

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硫普罗宁片人体药动学及生物等效性研究
王晓波¹, 袭荣刚¹, 刘丹¹, 程申强², 谢小青³, 关屹³, 刘洋³
1.解放军大连第210医院国家药物临床试验机构，辽宁大连 116021;2.上海迪冉郸城制药有限公司，上海 200000;3.沈阳亿灵医药有限公司，沈阳 110179

摘要:

目的研究健康受试者口服硫普罗宁片后的药动学及不同制剂间生物等效性。方法 LC-MS/MS测定硫普罗宁受试制剂和参比制剂给药后血浆中硫普罗宁的血浆药物浓度，用DAS软件计算药动学参数，并比较两制剂在健康人体的生物等效性。结果硫普罗宁片受试制剂和参比制剂的主要药动学参数是：t_1/2分别为(12.8±5.3)和(10.8±4.6)min；C_max分别为(7.02±1.35)和(7.16±0.81)g·mL^-1；AUC_0-t分别为(44.0±8.3)和(45.5±6.5)g·h·mL^-1；AUC_0-∞分别为(50.1±10.7)和(50.7±9.5)g·h·mL^-1。受试制剂与参比制剂相比，在人体的相对生物利用度为(96.8±11.5)%。结论硫普罗宁两种制剂药动学参数没有显著性差异，具有生物等效性。

关键词: 硫普罗宁液相色谱-质谱法药动学生物等效性

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Pharmacokinetics and Bioequivalence of Two Tiopronin Preparations in Healthy Volunteers

WANG Xiaobo¹, XI Ronggang¹, LIU Dan¹, CHENG Shenqiang², XIE Xiaoqing³, GUAN Yi³, LIU Yang³

1.State Agencies of Drug Clinical Trials, The 210th Hospital of PLA, Dalian 116021, China;2.Shanghai Dirandancheng Pharmaceutical Co., Ltd, Shanghai 200000, China;3.Shenyang E-living Medical Technology Co., Ltd, Shenyang 110179, China

Abstract:

OBJECTIVE To study the pharmacokinetics and bioequivalence of two tiopromin preparations in healthy volunteers. METHODS Tiopromin concentrations of the test and the reference tablets in plasma were determined by LC-MS/MS, the pharmacokinetic parameters were calculated by DAS software, and then their bioequivalene in healthy volunteers was studied. RESULTS The main pharmacokinetic parameters of the test and reference tablets were as follows: t_1/2 were (12.8±5.3) and (10.8±4.6)min; C_max were (7.02±1.35) and (7.16±0.81)g·mL^-1; AUC_0-t were (44.0±8.3) and (45.5±6.5)g·h·mL^-1, AUC_0-∞ were (50.1±10.7) and (50.7±9.5)g·h·mL^-1, respectively. The relative bioavailability of tiopronin test and reference tablets was (96.8±11.5)%. CONCLUSION The main pharmacokinetics parameters of two preparations have no significant difference. The results demonstrated that the two preparations were bioequivalent.

Key words: tiopronin LC-MS/MS pharmacokinetics bioequivalence