中国药物警戒 ›› 2011, Vol. 8 ›› Issue (12): 705-708.

• 基础及临床研究 •    下一篇

对乙酰氨基酚缓释微丸的制备及释放度研究

熊晓滨1, 李津明2, 李响2, 李鑫2   

  1. 1 烟台荣昌制药有限公司,山东 烟台 264006;
    2 哈尔滨商业大学药学院,黑龙江 哈尔滨 150076
  • 收稿日期:2011-09-30 出版日期:2011-12-10 发布日期:2015-07-30
  • 作者简介:熊晓滨,男,本科,高级工程师,药物研发。

Preparation and Release Behavior of Paracetamol Sustained-Selease Pellets

XIONG Xiao-bin1, LI Jin-ming2, LI xiang2, LI Xin2   

  1. 1 Yantai Rongchang Pharmaceutical Co. Ltd., Shandong Yantai 264006, China;
    2 School of Pharmacy, Harbin University of Commerce, Heilongjiang Harbin 150076, China
  • Received:2011-09-30 Online:2011-12-10 Published:2015-07-30

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摘要： 目的 制备对乙酰氨基酚缓释微丸,考察包衣处方等因素对微丸释放度的影响。方法 采用离心-造粒法制备微晶纤维素空白丸核和对乙酰氨基酚微丸,并在此基础上采用甲基丙烯酸树脂（Eudragit RS30D/RL30D）包衣,制备对乙酰氨基酚缓释微丸。采用HPLC法测定对乙酰氨基酚缓释微丸释放度,单因素筛选包衣处方的优化参数。结果 以Eudragit RS30D/RL30D比例为15:1（w/w）,包衣增重为10％,柠檬酸三乙酯占包衣材料量的25％,滑石粉占包衣材料量的40％为包衣液,制备的对乙酰氨基酚释微丸释药曲线具有较好的缓释特性。结论 制备的对乙酰氨基酚缓释微丸具有缓释特性且操作简便、工艺稳定。

关键词: 对乙酰氨基酚, 缓释, 微丸, 离心-造粒, 高效液相色谱法

Abstract: Objective In this paper we wanted to prepare paracetamol sustaied-release pellets and to study their release behavior. Methods Cenrifugal granulation method was used to prepare MCC pellets and paracetamol pellets respectively. On that basis Eudragit RS30D/RL30D as a coating material was adopted to coat the paracetamol pellets with a fluid bed spray processor. HPLC method was utilized to determine the release behavior of paracetamol sustained-release pellets. The coating prescription parameters were investigated and optimized with single factor experiments. Results The paracetamol sustained-release pellets coated with 10％coating material sustained released best, and the coating material consisted of Eudragit RS30D/RL30D(15:l,w/w), TEC(25％,w/w) and talc(40％,w/w). Conclusion These showed that paracetamol sustained-release pellets contained a characteristic of sustained-release and the established process and formula were simple and stable.

Key words: paracetamol, sustained-release, pellets, cenrifugal granulation, HPLC

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