对乙酰氨基酚缓释片的生产工艺研究

Study of Manufacturing Technology for Acetaminophen Extended Release Tablets

目的：研究制备对乙酰氨基酚缓释片最佳工艺。方法：通过测定颗粒的可压性和片剂释放度来评价并确定制备工艺。结果与结论：实验表明，分层制粒为较理想的制备工艺。采用该工艺所制样品的体外释放度和体内生物利用度与美国麦克尼尔公司进口的对乙酰氨基酚控释片基本一致，达到国外同品种的技术要求。

AIM: To achieve an optimum manufacturing process for acetaminophen extended release tablets. METHODS: To evaluate and set the manufacturing process according to the compressibility of the granule and the dissolubility of the finished tablets. RESULTS & CONCLUSION: The results showed that the bi-layer tablet technology was the most preferable pro- cess. The in vitro dissolution behavior and the in vivo bioavailability of the tablets are comparable to those of the imported products from McNEIL Consumer Healtheare Co. USA.