| 蔡颖,黄红谦,韦传姑.酮咯酸氨丁三醇片仿制药与原研药的生物等效性评价.[J].中南医学科学杂志.,2023,(1):65-68. |
| 酮咯酸氨丁三醇片仿制药与原研药的生物等效性评价 |
| The bioequivalence between generic and original ketorolac tromethamine tablet |
| 投稿时间：2022-03-09 修订日期：2022-06-25 |
| DOI：10.15972/j.cnki.43-1509/r.2023.01.016 |
| 中文关键词: 酮咯酸氨丁三醇片 药代动力学 生物等效性 安全性 [ |
| 英文关键词:ketorolac tromethamine tablet pharmacokinetics bioequivalence safety |
| 基金项目:海南省新药临床评价技术平台建设(2020ZX09201029) |
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| 中文摘要: |
| 目的探讨酮咯酸氨丁三醇(KT)片仿制药(受试剂)与原研药(参比剂)的生物等效性。 方法采用随机、开放、单剂量、双周期、双交叉对照试验,80例健康志愿者均分为空腹组和餐后组,均口服受试剂或参比剂。采用高效液相色谱法检测不同时间血浆KT质量浓度；计算血浆KT药代动力学参数；并对两种制剂进行生物等效性评价和安全性评价。 结果参比剂最大质量浓度(Cmax)、0时到最后时间点质量浓度-时间曲线下面积(AUC0-t)、0时到无限时间质量浓度-时间曲线下面积(AUC0-inf)空腹组为0.60 mg/L、3.66 h·mg/L、3.97 h·mg/L,餐后组为0.65 mg/L、4.26 h·mg/L、4.46 h·mg/L。受试剂Cmax、AUC0-t、AUC0-inf空腹组为0.58 mg/L、3.51 h·mg/L、3.80 h·mg/L,餐后组为0.62 mg/L、4.02 h·mg/L、4.20 h·mg/L。空腹和餐后条件下,受试剂和参比剂Cmax、AUC0-t、AUC0-inf及其90%CI均落在80%～125%范围内,符合生物等效性要求,无严重或重度不良事件发生。 结论健康受试者空腹或餐后口服KT片受试剂、参比剂具有生物等效性,安全性良好。 |
| 英文摘要: |
| AimTo explore the bioequivalence between thegeneric (test product) and the original (reference product) ketorolac tromethamine (KT) tablets. MethodsAccording to randomized, open, single-dose, double-cycle anddouble-cross controlled trial, 80 healthy volunteers were averagely divided into fasting group and postprandial group. All were given test product or reference product. The blood concentration of KT was detected by high performance liquid chromatography at different times. The pharmacokinetics parameters of plasma KT were calculated. Theevaluation of bioequivalence and safety in the two products was conducted. ResultsThe Cmax, AUC0-t and AUC0-inf of reference product in the fasting group were 0.60 mg/L, 3.66 h·mg/L and 3.97 h·mg/L,while those in the postprandial group were 0.65 mg/L, 4.26 h·mg/L and 4.46 h·mg/L. Cmax, AUC0-t and AUC0-inf of test product in the fasting group were 0.58 mg/L, 3.51 h·mg/L and 3.80 h·mg/L, while those in postprandial groupwere 0.62 mg/L, 4.02 h·mg/L and 4.20 h·mg/L. Under fasting and postprandial conditions, Cmax, AUC0-t, AUC0-inf and 90%CI of the test product and reference product were all within 80%－125%, meeting the requirements of bioequivalence,withoutserious or severe adverse events. ConclusionUnder fasting and postprandial conditions, there is bioequivalence between oral test and reference KT tablets in healthy objects, with good safety. |
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