两种碳酸钙维生素D片剂的人体相对生物利用度研究

Statistical simulation spectrophotometry for the determination of two components in compound metronidazole tablet

目的：比较两种市售口服碳酸钙维生素Ｄ制剂［凯思立Ｄ３片（ＣａＤ３）和钙尔奇Ｄ片（ＣａＤ）］的人体相对生物利用度。方法：８名健康志愿者随机分为两组，自身交叉单剂量口服ＣａＤ３片（含５００ｍｇ元素钙及维生素Ｄ３２００ｕ）和ＣａＤ片（含６００ｍｇ元素钙及维生素Ｄ３１２５ｕ）各一片。收集口服两钙剂前３ｄ及口服后２４ｈ尿量，用原子吸收光谱法测定尿中钙含量。结果：口服两钙剂前３ｄ的２４ｈ尿钙总量均值（基础尿钙值）分别为（１１８．５９±４１．１５）ｍｇ和（１３４．６４±５９．５０）ｍｇ；口服两钙剂后２４ｈ尿钙总量分别为（１９８．８８±５４．９９）ｍｇ和（２１８．９２±８９．７６）ｍｇ，均高于基础尿钙值。经剂量校正后，ＣａＤ３片和ＣａＤ片之相对生物利用度为（１１１．４８±１８．６９）％。上述参数之间均无显著性差异。结论：尽管ＣａＤ３片和ＣａＤ片的元素钙及维生素Ｄ３含量不等。

OBJECTIVE: To establish a statistical simulation spectrophotometry(SSS) for short, or Monte Carlo, assay of two components in compound formulation. METHODS: The method of stepwise regression and modified simplex method were used in the present study on metronidezole tablet, a compound formulation of two components. RESULTS: The recovery of metronidezole was 99.5% and viamine B6 100.8%. CONCLUTION: SSS is accurate, rapid, practicable and promising to be adopted as an official assay of some compound formulations.