Cho K, Sakata H, Fujita K, Yoshioka H, Mukai N
Jpn J Antibiot. 1985 Feb;38(2):253-62.
Laboratory and clinical studies on BRL 25000 granules (containing clavulanic acid (CVA) 1 part plus amoxicillin (AMPC) 2 parts) were performed in infections in the pediatric field. Following oral administration of BRL 25000 granules at a dose of 15 mg/kg body weight, the maximum serum levels of AMPC and CVA achieved approximately 1 hour after dosing were 8.68 micrograms/ml and 4.09 micrograms/ml and declined thereafter with half-lives of 1.39 and 0.80 hours, respectively. The 6-hour urinary recovery rates for AMPC and CVA were 55.81% and 26.08%, respectively. Following oral administration of BRL 25000 granules at a dose of 22.5 and 24.3 mg/kg body weight, the serum levels of AMPC and CVA peaked at 7.37 micrograms/ml and 2.98 micrograms/ml after 1 hour and declined with half-lives of 2.52 and 0.99 hours, respectively. The 6-hour urinary recovery rates for AMPC and CVA were 40.02% and 13.95%, respectively. The clinical efficacy of BRL 25000 granules was evaluated in 23 patients with upper respiratory tract infections, skin infections, etc. Overall the clinical efficacy was good to excellent in 21/23 (91.3%). The bacteriological and clinical efficacy rates for beta-lactamase producing bacteria and non-producing bacteria were 50% (1/2) and 100% (12/12), respectively. Side effects were observed in 1 patient, who experienced mild diarrhea and abdominal pain but not of a severe nature.
对BRL 25000颗粒剂（含克拉维酸（CVA）1份加阿莫西林（AMPC）2份）进行了儿科领域感染方面的实验室和临床研究。以15mg/kg体重的剂量口服BRL 25000颗粒剂后，给药后约1小时达到的AMPC和CVA的最高血清水平分别为8.68微克/毫升和4.09微克/毫升，此后下降，半衰期分别为1.39小时和0.80小时。AMPC和CVA的6小时尿回收率分别为55.81%和26.08%。以22.5和24.3mg/kg体重的剂量口服BRL 25000颗粒剂后，AMPC和CVA的血清水平在1小时后分别达到峰值7.37微克/毫升和2.98微克/毫升，并分别以2.52小时和0.99小时的半衰期下降。AMPC和CVA的6小时尿回收率分别为40.02%和13.95%。对23例上呼吸道感染、皮肤感染等患者评估了BRL 25000颗粒剂的临床疗效。总体而言，23例中有21例（91.3%）临床疗效为良好至优秀。产β-内酰胺酶细菌和非产酶细菌的细菌学和临床有效率分别为50%（1/2）和100%（12/12）。1例患者出现副作用，经历了轻度腹泻和腹痛，但不严重。
