月舒滴丸的溶出度研究  

Study on dissolution test of Yueshu dropping pills

作　　者：华莲[1] 郝桂明[1] 唐素芳[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《药物分析杂志》2009年第4期544-546,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立月舒滴丸的溶出测定方法。方法:采用小杯法,以0.01mol·L-1的盐酸溶液为溶出介质,转速50r·min-1测定溶出度,采用高效液相色谱法测定主成分阿魏酸的溶出量。结果:在8.196～102.4mg·L-1浓度范围内呈良好的线性关系(r=0.9999),平均回收率为100.3%。3批样品的溶出参数(T50、Td、m,m为形状参数)无明显差异(P>0.05)。结论:本方法简单、准确,为药品的质量控制提供了良好的保证。Objective：To establish a method of the dissolution determination of Yueshu dripping pills.Method：Small glass-method was adopted.Regarding 0.01 mol·L^-1 hydrochloric acid as the solvent,the speed rate for 50 r·min^-1,RP-HPLC method was used to determine the content of ferulic acid.Result：The assay displayed a good linearity over the concentration range of 8.196^-102.4 mg·L^-1（r=0.9999）,the average recovery was 100.3%,the dissolution parameters of three batchs （T50、Td、m,m was shape parameter ） had no significant different（P〉0.05）.Conclusion：The method is simple,accurate,and has provided the good guarantee for the drugs quality control.

关 键 词：月舒滴丸 溶出度 小杯法 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]