中国药物警戒 ›› 2014, Vol. 11 ›› Issue (9): 531-535.

• 质量与工艺研究 • 上一篇    下一篇

阿托伐他汀钙片溶出度研究

蔡垠1, 朱金莲1, 武利1, 周志亮1, 苗艳1, 戴林东2*   

  1. 1润泽制药（苏州）有限公司,江苏 苏州 215126;
    2礼来苏州制药有限公司,江苏 苏州 215021
  • 收稿日期:2014-03-11 修回日期:2016-02-03 出版日期:2014-09-08 发布日期:2016-03-02
  • 通讯作者: 戴林东,男,本科,工程师,制药工程。
  • 作者简介:蔡垠,女,硕士,工程师,新药研发。

Research on the Dissolution Profiles of Atorvastatin Calcium Tablets

CAI Yin1, ZHU Jin-lian1, WU Li1, ZHOU Zhi-liang1, MIAO Yan1, Dai Lin-dong2, *   

  1. 1Runze Pharmaceutical (Suzhou) Co., Ltd., Jiangsu Suzhou 215126, China;
    2Lilly suzhou pharmaceutical Co., Ltd., Jiangsu Suzhou 215021, China
  • Received:2014-03-11 Revised:2016-02-03 Online:2014-09-08 Published:2016-03-02

PDF (PC)

719

摘要： 目的建立阿托伐他汀钙片溶出度研究方法。方法色谱柱：Agilent TC-C18（4.6×250 mm,5 μm）;以乙腈：四氢呋喃：0.05 M柠檬酸铵缓冲液（pH 4.0）=27:20:53为流动相;检测波长：244 nm;流速：1.5 mL·min-1;以阿托伐他汀钙与阿托伐他汀钙杂质H峰面积之和计算累积溶出量（%）;结果 阿托伐他汀钙在pH 1.0盐酸溶液、醋酸-醋酸铵缓冲液（pH 4.5）中不稳定,降解生成阿托伐他汀钙杂质H,阿托伐他汀钙片在pH 1.0盐酸溶液中溶出速率最慢;结论 阿托伐他汀钙在pH 1.0盐酸溶液中溶出曲线可作为处方筛选的依据。

关键词: 阿托伐他汀钙, 阿托伐他汀钙杂质H, 溶出度, 累积溶出量（%）, 校正因子

Abstract: ObjectiveTo establish the dissolution method of atorvastatin calcium tablets. MethodsColumn Agilent TC-C18(4.6×250 mm, 5μm) with mobile phase consisted of acetonitrile: tetrahydrofuran: 0.05 M ammonium citrate buffer pH 4.0 (27:20:53) at a flow rate of 1.5 mL·min-1 when the detective wavelength was set at 244 nm, plus the atorvastatin and atorvastatin related compound H peak area to calculate the cumulative release amount(%); ResultsAtorvastatin calcium was instable in pH 1.0 hydrochloric acid solution and acetic acid- ammonium acetate buffer (pH 4.5) and degrade to atorvastatin related compound H, the pH 1.0 hydrochloric acid solution dissolution profile of atorvastatin calcium tablets was the slowest one. ConclusionThe pH 1.0 hydrochloric acid solution dissolution profile of atorvastatin calcium tablets can be used as the basis for formulation screening.

Key words: atorvastatin calcium, atorvastatin related compound H, dissolution, cumulative release amount (%), correction factor

中图分类号: