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盐酸左旋沙丁胺醇缓释片释放度测定方法的研究
引用本文:许良葵,张蜀,林华庆,邓红. 盐酸左旋沙丁胺醇缓释片释放度测定方法的研究[J]. 广东药学院学报, 2007, 23(6): 607-609,614
作者姓名:许良葵  张蜀  林华庆  邓红
作者单位:广东药学院,药物研究所/广东省药物新剂型重点实验室,广东,广州,510006
基金项目:2006年广州市科技计划项目(2006Z3-E406)
摘    要:目的研究自制盐酸左旋沙丁胺醇缓释片的体外释放度。方法采用《中国药典》附录ⅩC第三法,pH 1.2的盐酸缓冲液和pH 6.8磷酸盐缓冲液为释放介质,转速50r·min~(-1),累计释药量检测方法为高效液相色谱法。结果平均回收率100.8%,RSD=0.32%,3批产品在2、4、8h的平均累积释药量分别为44.87%、67.57%和84.72%,药物释放符合Weibull方程模型。结论自制盐酸左旋沙丁胺醇缓释片有较好的释药性能,本文建立的释放度测定方法可作为该制剂的质控方法。

关 键 词:高效液相色谱法  盐酸左旋沙丁胺醇  缓释片  释放度
文章编号:1006-8783(2007)06-0607-03
收稿时间:2007-10-09
修稿时间:2007-11-15

Release of levalbuterol hydrochloride sustained released tablets in vitro
XU Liang-kui,ZHANG Shu,LIN Hua-qing,DENG Hong. Release of levalbuterol hydrochloride sustained released tablets in vitro[J]. Academic Journal of Guangdong College of Pharmacy, 2007, 23(6): 607-609,614
Authors:XU Liang-kui  ZHANG Shu  LIN Hua-qing  DENG Hong
Abstract:Objective To study the in vitro dissolution rate of levalbuterol hydrochloride sustained released tablets.Methods Following the CHP appendix XC (method three),the hydrochloric acid solution (pH=1.2) and PBS (pH=6.8) was taken as release medium. Rotation speed is 50 r/rain and dissolution rate was determined by HPLC.Results Average recovery was 100.8% (RSD=0.32%). The average cumulative releases were 2 h(44.87%),4 h(67.57%),8 h(84.72%).The drug release profile in vitro was followed Weibull model equation.Conclusion The study indicates that the sustained released tablet had satisfactory sustained release characteristics.The method could be used for the quality control of levalbuterol hydrochloride sustained released tablets.
Keywords:HPLC  levalbuterol hydrochloride  sustained released tablets
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