健康志愿者头孢克罗尿药浓度测定及3种制剂尿排量比较

目的:比较头孢克罗3种制剂的尿药浓度和尿排量.方法:8名健康志愿者分别单剂量po国产头孢克罗缓释片、头抱克罗普通胶囊和进口头孢克罗缓释片750mg,采用反相高效液相色谱法(RP-HPLC)测定尿中头孢克罗浓度,计算8h分段和累积尿排量及尿排百分率,用配对t检验比较3种制剂尿药浓度和尿排量.结果:国产缓释片与进口缓释片相比,相应各时间段尿药浓度无显著性差异,8h分段和累积尿排量无显著性差异;普通胶囊0～2h尿药浓度和尿排量较缓释片高,2～4、4～6、6～8h均低于缓释片,但3种制剂8h累积尿排量和尿排百分率无显著性差异.结论:缓释片维持有效尿药浓度时间比普通胶囊长.

Determination of cefaclor in human urine and comparison of urinary excretive amount in healthy subjects among three cefaclor preparations

AIM:To compare cefaclor concentration in urine and urinary excretive amount among cefaclor capsule (Cefaclor) , imported and domestic sustained release tablet. METH-ODS: Eight healthy subjects were administered with single oral dose of 750 mg of 3 cefaclor preparations respectively. A RP-HPLC method was developed for the determination of cefa-clor in human urine. Urinary excretive amount and percentage recovery rate of cefaclor were calculated in 8 h after administration. T test was adopted in comparison with concentration in urine,excretive amount in 3 preparations. RESULTS:There was no significant difference in cefaclor concentration in urine and urinary excretive amount 8 h after administration between domestic and imported sustained release tablets. Cefaclor capsule had higher levels in the o-2 h collection interval and lower levels in the 2-4,4-6,6-8 h collection intervals than sus-tained release tablet. It showed no statistical significance in accumulated urinary excretive a-mount among 3 cefaclor preparations. CONCLUSION: Sustained release tablets maintain longer periods of time than that of cefaclor capsule. Then,it appears to be suitable for twice-daily administration, whereas cefaclor capsule should probably be administered 3 or even 4 times a day.