摘要
以红霉素为模型药物，用自制的丙烯酸树脂Ⅱ号假胶乳为包衣液，制备红霉素肠溶片，并以市售片为参比标准，进行了体内外研究。参照中国药典９０版及美国药典ＸＸＩＩ版分别进行了崩解时限及溶出度测定。９名受试者分别交叉口服两制剂（１２５ｍｇ×４，自制片Ａ，市售片Ｂ），采用微生物法测定血清中红霉素浓度，实验表明两制剂药动学参数无显著差异，Ｃｍａｘ分别为（２．１９±０．７９）μｇ／ｍｌ（Ａ），（１．７１±０．７８）μｇ／ｍｌ（Ｂ），ｔｍａｘ分别为（４．７５±１．３４）ｈ（Ａ），（５．５９±０．９９）ｈ（Ｂ）；相对生物利用度（Ａ／Ｂ）为１．０７±０．１５。
This paper deals with the preparation and evaluation of enteric tablet erythromycin coated by acrylic resin No. 2 pseudolatex (A),compared with the commerially available enteric-coated erythromycin tablet(B),in vitro and in vivo. The disintegration and dissolution test has been done, based on Pharmacopoeia of the People's Republic of China 1990 and USP 22 respectively, In the bioavailability study, both tablets are orally administrated by cross over method to 9 volunteers with 500mg single dose. Erythromycin serum concentration is determined by microbial assay between A and B. The peak concentrations are 2.19±0. 79 and 1.71±0.78μg/ml; the peak times are 4.75±1.34 and 5.59±0.99 h for A and B, respectively. The relative bioavailability (AUCA/AUCB) is 1.07±0.15. The results show that there is no statistical difference in pharmacokinetic parameters between two preparations.
出处
《中国药科大学学报》
CAS
CSCD
北大核心
1994年第5期267-270,共4页
Journal of China Pharmaceutical University
关键词
丙烯酸树脂
包衣
红霉素
肠溶片
制备
Acrylic resin No.2 pseudolatex
Coating
Enteric-coated erythromycin
Bioavailability
