以尿钙排泄量为效应指标评价枸橼酸氢钾钠颗粒人体生物等效性

Evaluation of the bioequivalence of domestic and imported Potassium Sodium Hydrogen Citrate Granules with accumulative urinary excretion of calcium as index in healthy volunteers

目的以24h尿液钙离子累计排泄量为指标，比较国产和进口枸橼酸氢钾钠颗粒剂的生物等效性。方法36名男性健康志愿者按自身交叉设计，随机口服枸橼酸氢钾钠颗粒剂的受试制剂（国产）或参比制剂（进口）5．0g，（洗脱期7d）。分别收集给药前（空白）和给药后0～2、2～4、4～6、6～8、8～10，10-2、12～24h的尿液，记录尿量，采用原子吸收分光光度法测定尿液钙离子浓度，计算给药前、后24h尿液钙累积排泄量。结果受试制剂给药前、后24h尿钙累积排泄量为（128．47±76．45）mg和（163．53±81．28）mg；参比制剂给药前、后24h尿钙累积排泄量为（128．34±59．55）mg和（179．65±103．96）mg。给予受试制剂和参比制剂后24h尿钙排泄量分剐比用药前增加（35．06±61．26）mg和（51．31±73．18）mg，两制剂间没有显著性差异（P〉0．05）。结论国产和进口枸橼酸氢钾钠颗粒剂具有生物等效性，尿液钙离子累计排泄量可用于国产和进口构橼酸氢钾钠颗粒剂生物等效性评价。

Objective To evaluate the bioequivalence of imported and domestic Potassium Sodium Hydrogen Citrate Granules with accumulative urinary excretion of calcium as index in Chinese healthy volunteers. Methods Thirty - six healthy male volunteers were randomLy administered with a oral single dose of 5.0 g domestic （test） and imported （ refer- ence） Potassium Sodium Hydrogen Citrate Granules in a crossover study with a washout period of 7 days. Urine was collect- ed before or after oral doses at the scheduled time （0 - 2,2 - 4,4 - 6,6 - 8,8 - 10, l0 - 12,12 - 24 h ） . Urine volumes were recorded,urinary calcium concentration was determined by atomic absorption spectrophotometric and twenty - four hours of accumulative urinary excretion of calcium were calculated. Results Twenty - four hours of accumulative urinary excretion of calcium were （ 128.47± 76.45 ）mg and （ 163.53 ± 81.28 } mg before and after taking test preparation ; （ 128.34 ±59.55 ）mg and （ 179.65 ±103.96 ）mg before and after taking reference preparation, respectively. Increase in 24 h urinary excretion of calcium after taking test and reference preparation were （ 35.06 ± 61.26 ） mg and （ 51.31 ± 73.18 ） mg, respec- tively. There was no significant difference（ P 〉 0.05 ） in increase of 24 h accumulative urinary excretion of calcium between the two preparations. Conclusion The domestic and imported Potassium Sodium Hydrogen Citrate Granules were bioequiv- alent.