论文部分内容阅读
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。
Erythromycin was used as a model drug, and the homemade latex of acrylic resin Ⅱ was used as the coating liquid to prepare erythromycin enteric-coated tablets. The commercial tablets were taken as the reference standard for in vitro and in-vivo studies. With reference to the Chinese Pharmacopoeia 90 edition and the United States Pharmacopoeia XXII edition were determined the dissolution time and dissolution. Nine subjects were orally administered with two preparations (125mg × 4, self-made tablet A, commercially available tablet B), and the concentration of erythromycin in serum was determined by the microbiological method. The results showed that there was no significant difference in pharmacokinetic parameters between the two preparations. Cmax (2.19 ± 0.79) μg / ml (A) and (1.71 ± 0.78) μg / ml (B) respectively, the tmax values were (4.75 ± 1.34) h , (5.59 ± 0.99) h (B), respectively. The relative bioavailability (A / B) was 1.07 ± 0.15.