摘要
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 bioequivalent of domestic injections of salcaltonin. METHODS: 12 healthy male volunteers were randomized into two groups. According to crossover design, intramuscular injection of 100 IU of domestic and imported salcaltonin was given to the two groups respectively. The concentrations of serum salcaltonin were determined by enzyme immunoassay. RESULTS: The pharmacokinetic parameters showed: Cmax were 2.31±0.16 ?g·L-1 and 2.44±0.20 ?g·L-1; 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; Ke were 0.0079±0.0023 min-1 and 0.0084±0.0014 min-1; CL(s) were 0.018±0.004 L·min-1 and 0.017±0.003 L·min-1; V/F(c) were 1.98±0.47L and 1.97±0.29L; AUC(0~360min) were 297.70±44.45 ?g·min·L-1 and 313.64±46.03?g·min·L-1, respectively. The relative bioavailability of domestic salcaltonin is 97.6±25.6%. CONCLUSIONS: The results of two direction one-sided T test demonstrated that two formulations are bioequivalent.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2000年第5期362-364,共3页
The Chinese Journal of Clinical Pharmacology
