摘要
研究8例男性健康志愿者交叉口服乙酰吉他霉素颗粒剂的参比药品和被试药品后的药动学和相对生物利用度。口服后不同时间收集血和尿样本。用微生物法测定血清和尿中乙酰吉他霉素浓度．检测菌为藤黄八叠球菌28001。用MCPKP软件经微机处理血清浓度-时间数据，结果证明，参比药品和被试药品均符合一房室开放模型．两组间的各项药动学参数及24h尿中总排泄率均无显著性差异，被试药品的相对生物利用度为119.2％±31％。表明两个药厂生产的乙酰吉他霉素颗料剂具有同等的效果。
The pharmacokinetics and relative bioavailability of control and testedacetylkitasamycin (AKM) granules were studied in 8 male healthy volunteers who receivedcontrol and tested AKM of 0. 8g orally in crossways. Blood and urine samples were co1lectedat various time after oral administration. The serum and urine concentrations of AKM weredetermined by microbio1ogy method. The tested microorganism was Sarcina lutea 28001.The data of serum level-time were disposed with MCPKP software and microcomputer.Results demonstrated that the data of control and tested AKM fitted to one-compartmentopen model. There was no significant difference of the pharmacokinetic paramcters and 24hurine excretory rate between the two groups. The relative bioavailability of the tested AKMwas 119. 2% ±31%. The results showed that the AKM produced by the two pharmaceuticalfactories had the same effect.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
1997年第1期37-39,53,共4页
Chinese Journal of Antibiotics
关键词
乙酰吉他霉素
生物利用度
颗粒剂
Acetylkitasamycin, Pharmacokinetics, Relative bioavailability
