| 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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| 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：t1/2分别为(12.8±5.3)和(10.8±4.6)min；Cmax分别为(7.02±1.35)和(7.16±0.81)g·mL-1；AUC0-t分别为(44.0±8.3)和(45.5±6.5)g·h·mL-1；AUC0-∞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 |
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WANG Xiaobo1, XI Ronggang1, LIU Dan1, CHENG Shenqiang2, XIE Xiaoqing3, GUAN Yi3, LIU Yang3
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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
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| 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: t1/2 were (12.8±5.3) and (10.8±4.6)min; Cmax were (7.02±1.35) and (7.16±0.81)g·mL-1; AUC0-t were (44.0±8.3) and (45.5±6.5)g·h·mL-1, AUC0-∞ 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 |
