甲磺丁脲为磺酰脲类化合物,是水难溶性的口服降血糖药。为了解国产片的质量情况,本文收集国内四厂五批甲磺丁脲片剂,作溶出度的测定,同时对崩解时间、硬度与溶出度的相关性也进行了研究,并测定了样品的均匀度和体内降血糖的效果,为改进生产,正确评价本品质量提供方法和依据。一、溶出度试验1.实验材料与仪器纯品:上海十九制药厂批号840101 Mebutamide is a sulfonylurea that is a poorly water-soluble oral hypoglycemic drug. In order to understand the quality of Chinese-made tablets, five batches of metobadicum tablets from four domestic factories were collected for determination of dissolution rate. The correlation between disintegration time, hardness and dissolution rate was also studied. Uniformity and in vivo hypoglycemic effect, in order to improve production, the correct evaluation of the quality of this product provide the basis and method. First, the dissolution test 1. Experimental Materials and Instruments Pure: Shanghai No. 19 Pharmaceutical Factory Lot 840101