| 郝莎莎1，2 孙鹤1，2△ 马晓慧1，2 魏静1.长半衰期药物无清洗期时的生物等效性研究*[J].,2014,14(2):230-234 |
| 长半衰期药物无清洗期时的生物等效性研究* |
| Methodology on the no Washout Period Bioequivalence of LongHalf-life Drugs* |
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| DOI： |
| 中文关键词: 长半衰期药物 生物等效性 清洗期 采样时间 |
| 英文关键词: Long elimination half-life drugs Bioequivalence evaluation Washout period Sampling time |
| 基金项目:国家科技重大专项课题：面向国际的创新中药大平台建设（2013zx09402202） |
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| 中文摘要: |
| 摘要目的：探讨长半衰期药物（t1/2>24 h）在无清洗期时生物等效性研究中的AUC 和Cmax 的计算，通过无清洗期的实验数据推
算出正常清洗期的数据。方法：利用SPSS软件，建立二室模型口服药物在无清洗期时的半衰期为100 小时的生物等效性模型，通
过优化AUC和Cmax 的计算方法，降低药物残留对第二周期药物浓度的影响，进而增加AUC 和Cmax 的计算的精确性，最后用
较精确的方法推算出正常清洗期的AUC 和Cmax，利用精确的数据进行生物等效性的进一步验证。结果：在无清洗期的状态下，
取样时间在大于0.8 个半衰期时，平均值法计算的AUC 和Cmax 的结果误差小于5 %，变异系数小于25 %，较为精确，生物等效
性研究进一步验证了这一观点。结论：在无清洗期的情况下，生物等效性研究最小的采样时间为0.8 个半衰期。 |
| 英文摘要: |
| ABSTRACT Objective：To investigate the calculation method of AUC and Cmax in long half-life drugs on no washout period
bioequivalence and calculate the normal washout period data through the experimental data without washout period. Methods：This study
established a two-compartment oral drugs bioequivalence model with no washout period taking advantage of SPSS software. It reduced
the impact of drug residues in second period administered drug by optimizing the calculation method of AUC and Cmax, And then the
calculate precision was increased. Finally, a more accurate calculation method was used to conjecture the normal cleaning period of the
AUC and Cmax, and it would further be verified by the bioequivalence study. Rusults：In no washout period bioequivalence, the
calculation results of AUC and Cmax error was less than 5 %, the variation coefficient was less than 25 % in more than 0.8 half-life
sampling time. The bioequivalence result had further verified this opinion. Conclusion：In the no washout period case, bioequivalence
study sampling time at least 0.8 half-life. |
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