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目的：比较国产和进口的３种口服补钙剂对健康志愿者的生物等效性。方法：１０名健康志愿者随机４组交叉，不服药或ｐｏ单剂量１０００ｍｇ元素钙的补钙剂后，采集测定８ｈ内的血清钙浓度和２４ｈ内的尿钙浓度。结果：空白和服用制剂Ａ，Ｂ，Ｃ后的血清药时曲线下面积ＡＵＣ０ｈ～８ｈ分别为（６７４．２±４９．０８）ｍｇ·ｈ·Ｌ－１，（７２８．７±４２．４７）ｍｇ·ｈ·Ｌ－１，（７１７．５±５１．３４）ｍｇ·ｈ·Ｌ－１，（６９７．３±５２．７３）ｍｇ·ｈ·Ｌ－１；０ｈ～４ｈ和０ｈ～２４ｈ尿钙排泄量分别为（１３．０６±９．８８）ｍｇ，（６５．２０±２４．９７）ｍｇ；（３４．０７±１７．６７）ｍｇ，（１３８．２５±５７．３５）ｍｇ；（３４．１１±２５．９７）ｍｇ，（１４７．４１±８５．７９）ｍｇ，（２５．７７±１２．４９）ｍｇ，（９９．３７±４８．２０）ｍｇ。结论：经统计学判定，本方法检测可见，服用制剂Ａ，Ｂ，Ｃ后血钙浓度和尿钙排量与不服药组有明显差异，但３种制剂间无显著性差异。表明国产和进口的钙制剂对体内钙行为的影响是一致的。
Objective: To compare the bioequivalence of three oral calcium supplements made in China and imported to healthy volunteers. Methods: Ten healthy volunteers were randomly divided into four groups: crossover, no dose of calcium or calcium supplementation of single dose of 1000 mg po, serum calcium concentration within 8 hours and urinary calcium concentration within 24 hours were collected. Results: The area under the curves of AUC0h ~ 8h after taking medicine A, B, and C were (674.2 ± 49.08) mg · h · L-1, (728.7 ± 42.47) ), Mg · h · L-1, (717.5 ± 51.34) mg · h · L-1, (697.3 ± 52.73) mg · h · L-1, 0h ~ 4h and 0h ~ 24h The urinary calcium excretion were (13.06 ± 9.88) mg, (65.20 ± 24.97) mg, (34.07 ± 17.67) mg, (138.25 ± 57.35) mg, (34.11 ± 25.97) mg, (147.41 ± 85.79) mg, (25.77 ± 12.49) mg, (99.37 ± 48.20) mg respectively. Conclusion: The results of this method showed that there was a significant difference in blood calcium concentration and urinary calcium excretion between groups A, B and C after taking the test, but there was no significant difference among the three preparations. The results showed that domestic and imported calcium preparations had the same effect on in vivo calcium behavior.