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格列美脲片(glimepiride tablets)是一种新的磺酰脲类降糖药,其适应症是治疗饮食和体育锻炼未能适当控制症状的Ⅱ型糖尿病。文献报道用高效液相色谱法、放射同位素法测定格列美脲体内血药浓度及代谢产物,其含量及溶出度测定未见文献报道,该药为水不溶性药物,实验选定以0.02％三羟甲基氨基甲烷为溶剂,并系统地建立紫外分光光度法测定其溶出度,该法可有效地控制其质量,方法简便、准确,现报告如下。
Glimepiride tablets, a new sulfonylurea hypoglycemic agent, are indications of type 2 diabetes for which diet and physical activity fail to adequately control symptoms. Reported in the literature using high performance liquid chromatography, radioisotope determination of glimepiride in vivo plasma concentrations and metabolites, the determination of its content and dissolution has not been reported in the literature, the drug is water-insoluble drugs, the experiment was selected to 0.02% tris Hydroxymethylaminomethane as solvent, and the establishment of a system of UV spectrophotometry determination of dissolution, the method can effectively control its quality, the method is simple and accurate, are as follows.