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本文采用新研制开发的肠溶辅料羟丙基甲基纤维素酞酸酯（ＨＰＭＣＰ）将呋喃妥因制成肠溶薄膜衣片。实验考察了包衣片剂质量及用尿药法测定了其人体生物利用度，并与呋喃妥因市售片及丙烯酸树脂肠溶衣片进行了比较。体外质量考察结果表明，ＨＰＭＣＰ包衣片硬度及脆碎度与二种对照片相当；ＨＰＭＣＰ包衣片及丙烯酸树脂包衣片的崩解时限分别为（２．４９±０．２ｌ）ｍｉｎ和（７．４９±ｌ．１７）ｍｉｎ，其溶出度参数Ｔ５０则分别为１２ｍｉｎ和５２．８ｍｉｎ．体内尿药浓度测定结果，ＨＰＭＣＰ包衣片、市售片及丙烯酸树脂肠溶衣片尿药累积排泄百分数分别为３３．９％，２４．Ｏ％及２０．９％，说明前者生物利用度明显高于后二者。
In this paper, the newly developed enteric-coated hydroxypropyl methyl cellulose phthalate (HPMCP) will nitrofurantoin into enteric-coated film-coated tablets. The quality of the coated tablets and the bioavailability of the coated tablets by urinary drug method were investigated experimentally, and compared with the commercially available tablets of nitrofurantoin and acrylic enteric-coated tablets. The results of in vitro examination showed that the hardness and friability of HPMCP coated tablets were comparable to those of the two preparations. The disintegration time of HPMCP coated tablets and acrylic coated tablets were (2.49 ± 0.2l) min and ( 7.49 ± l.17) min, the dissolution parameters T50 were 12min and 52.8min respectively. In vivo urine concentration measurement results, HPMCP coated tablets, commercial tablets and acrylic enteric-coated tablets urinary cumulative excretion percentage were 33.9%, 24. O% and 20.9%, indicating that the former bioavailability was significantly higher than the latter two.