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目的：研究国产鲑鱼降钙素注射液的生物等效性。方法：12名健康男性志愿者随机交叉肌肉注射单剂量国产鲑鱼降钙素注射液及进口鲑鱼降钙素注射液100 IU进行药代动力学和相对生物利用度研究。方法：酶免疫分析方法 (EIA) 测定血清中药物浓度。结果：肌肉注射鲑鱼降钙素后体内动力学过程符合一房室模型，国产及进口制剂的Cmax分别为2.31±0.16?g·L-1和2.44±0.20?g·L-1；Tmax分别为48.75±12.99 min和52.50±16.31 min；T1/2ke分别为 92.93±11.86 min和 97.61±11.23 min；Ke分别为 0.0079±0.0023 min-1和 0.0084±0.0014 min-1；CL(s)分别为0.018±0.004 L·min-1和0.017±0.003 L·min-1；V/F(c)分别为1.98±0.47L和1.97±0.29L；AUC(0～360)分别为297.70±44.45?g·min·L-1和 313.64±46.03?g·min·L-1。以进口产品为参比制剂，国产注射液的相对生物利用度为97.6±25.6%。两种注射剂的主要药代动力学参数经配对t检验无显著性差异（P>0.05），Cmax 、AUC(0～360)值对数转换后经方差分析、双向单侧t检验。结论：显示二者具有生物等效性。
Objective: To study the bioequivalence of domestic salmon calcitonin injection. Methods: Twelve healthy male volunteers were randomized to cross intramuscular injection of single-dose salmon calcitonin injection and imported salmon calcitonin injection 100 IU for pharmacokinetics and relative bioavailability. Methods: Enzyme immunoassay (EIA) was used to determine the concentration of drug in serum. RESULTS: The in vivo kinetics of intramuscular injection of salmon calcitonin was in accordance with a one-compartment model. The Cmax of domestic and imported preparations were 2.31 ± 0.16 μg · L-1 and 2.44 ± 0.20 μg · L-1, respectively. The Tmax were 48.75 ± 12.99 min and 52.50 ± 16.31 min; T1 / 2ke were 92.93 ± 11.86 min and 97.61 ± 11.23 min respectively; Ke was 0.0079 ± 0.0023 min-1 and 0.0084 ± 0.0014 min-1, respectively; 0.004 L · min -1 and 0.017 ± 0.003 L · min -1; V / F (c) was 1.98 ± 0.47 L and 1.97 ± 0.29 L, respectively; AUC values were 297.70 ± 44.45 g · min · L-1 and 313.64 ± 46.03 μg · min · L-1. The imported products as reference preparation, the relative bioavailability of domestic injection was 97.6 ± 25.6%. The main pharmacokinetic parameters of the two injections were not significantly different (P> 0.05) by paired t-test. The logarithm of Cmax and AUC (0 ~ 360) were log transformed and analyzed by ANOVA and two-way unilateral t test. Conclusion: The two are shown to be bioequivalent.