摘要
目的 :评价国产与进口盐酸氨溴索片的溶出特性。 方法 :选择 0 .1mol/ L HCl为溶出介质 ,采用高效液相色谱法检测 ,色谱柱 :Hypersil C1 8(10μm ,15 0 m m× 4 .6 mm ) ;流动相 :甲醇 -水 -四氢呋喃 -三乙胺 (71∶ 2 9∶ 2 .5∶ 0 .2 5 ) ;波长 :2 4 2 nm。利用 Excel电子表格软件分别计算两种片剂的 Weibull分布参数。 结果 :2种盐酸氨溴索片溶出迅速稳定 ,8m in内平均累计溶出 85 %以上。溶出过程均符合 Weibull分布模型 ,溶出参数 m有统计学差异 (P<0 .0 5 )。结论 :两种盐酸氨溴索片的体外溶出度均符合片剂的基本要求 。
Objective: To evaluate dissolution properties of 2 kinds of ambroxol hydrochloride tablets.Methods: A HPLC method was used.The column was Hypersil C 18 (10 μm,150 mm×4.6 mm).The mobile phase was methnol water tetrahydrofuran triethylamine (71∶29∶2.5∶0.25).The wavelength of detector was 242 nm.Data were analyzed by Weibull's distribution model.Results: Both tablets dissolved rapidly and their dissolution rate reached 85% in the first 8 min.But there was significant statistic differences between the 2 tablets as for Weibull's parameters.Conclusion: Although the dissolution rate of 2 tablets is similar,there are still some differences between their dissolution parameters.The dissolution of the imported tablets is more rapid than the home made ones.
出处
《第二军医大学学报》
CAS
CSCD
北大核心
2002年第12期1369-1371,共3页
Academic Journal of Second Military Medical University
基金
全军医学科技研究"十五"重点课题(0 1Z0 0 6)
