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β-胡萝卜素的血药浓度测定法及人体生物等效性

Determination of Serum Level of β-carotene and Its Bioequivalence in Man

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【作者】 何海霞朱治本周远大雷自强杨苏王丕龙

【Author】 HE Haixia ;ZHU Zhiben;ZHOU Yuanda;LEI Ziqiang(Dept.of Clinical Pharmacology,The College of Clinical Medicineof Chongqing University of Medical Sciences,Chongqing 400016)YANG Shu;WANG Peilong(Laboratory of Artifical Liver,Dept.of Gastroenterology,The Colle

【机构】 重庆医科大学临床学院临床药理研究室!重庆市400016重庆医科大学消化科人工肝实验室!重庆市重庆医科大学消

【摘要】 建立了分光光度法测定人血清中β-胡萝卜素的浓度。样品用正己烷提取后,在450nm处测定。β-胡萝卜素的线性范围0.25~4μg/ml,最低检出浓度0.0625μg/ml,平均回收率96.11±3.09%(n=9)。应用本法对12名健康志愿者自体交叉口服不同厂家的β-胡萝卜素片剂和胶囊剂后的血药浓度进行了测定,结果表明,2种制剂的t1/2Ke分别为4.33d和4.82d,各个体AUC(0~22d)的均值分别为18.51和16.13μg/(ml·d),β-胡萝卜素片剂的相对生物利用度为114.76%,经统计分析,2种制剂具有生物等效性。

【Abstract】 An UV-spectrophotometry has been developed for determination of β-carotene in serum. β-carotene in samples wasextracted with n-hexane,detected at UV450nm.There was a good linear relationship within the range of 0.25-4μg/ml.The detactableminimum concentration this drug in serum was 0.0 625μg/ml.The average recovery was 96.11 ±3.09%(n=9).This method has beenapplied to monitoring serum levels of β-carotene in 12 adult male volunteers who were divided into two groups and receivedalternative p.o.administration of either H β-carotene tablets or S β-carotene capsules.The results showed that t1-2 Ke and AUC0-22d oftwo forms of β-carotene preparation were 4.33d and 4.82d;18.51 and 16.13μg/(ml. d),res pectively.The relative bioavailability of Hβ-carotene tablet was 114.76% .The results showed that the two forms of drug were bioequialent.

  • 【分类号】R96
  • 【被引频次】1
  • 【下载频次】46
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