复方盐酸二甲双胍片溶出度测定方法的研究

Research about dissolution rate of Compound Metformin Hydrochloride Tablets

目的 考察复方盐酸二甲双胍片体外释放行为,制定合理的溶出度测定条件。方法 (1)以 10 0 0ml水为溶出介质,转速 75rpm,4 5min时取样,采用UV法于 2 33nm的波长处测定。(2 )以 0 0 2 %三(羟甲基)氨基甲烷 2 5 0ml为介质,转速为75rpm时,4 5min取样,采用HPLC法于 2 2 8nm测定格列本脲的溶出度。结果 盐酸二甲双胍的水溶液在 1 6 2～ 8 12 μg·ml-1浓度范围内,吸收度与浓度呈良好的线性关系;平均回收率 99 80 %。格列本脲溶出液在 4 10～ 6 16 μg·ml-1浓度范围内,吸收度与浓度呈良好的线性关系;平均回收率 10 0 16 %。结论 本品溶出迅速,主药在 4 5min内均可完全溶出,且均一性好。

Objective To study the dissolution behavior of Compound Metformin Hydrochloride Tablets in vitro, and determinate the condition of its dissolution rate.Methods (1)Water(1000ml) was used as dissolution of medium wi th a rotation rate of 75r pm.Samples were taken at 45min and Metformin Hydrochloride was determined at 23 3nm by UV.(2) 0.02% Tris (hydroxymethyl) aminomethane (250ml) was used as diss ol ution of medium with a rotation rate of 75rpm.Samples were taken at 45min and Glibenchloride was determined at 228nm by HPLC.Results In water,the calibration curve of Metformin Hydrochloride was linear in the range of 1.62～8. 12μg·ml -1 ,and the average recovery rate was 99.80%.The calibration cur ve of Glibencla mide was linear in the range of 4.10～6.16μg·ml -1 ,and the average rec overy rate was 10 0.16%.Conlusion The tablets were dissolved rapidly, and acti ve component cou ld completely dissolved within 45min.Compound Metformin Hydrochloride Tablets showed an excellent dissolution behavior in vitro.