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甲苯磺丁脲(Tolbutamide)是一种口服降血糖药。由于在水中极微溶解,口服后胃肠道吸收受溶出速率所限。早在1963年就发现此药所制成的片剂在临床上有的有效,有的无效。Levy通过溶出试验证实临床疗效较差的片剂,其药物溶出速度也极慢。又发现不同厂别及不同批号片剂的溶出速度之间存在着差异。因此,国外已将甲苯磺丁脲片列为存在生物利用度问题的制剂之一。美国药典20版规定本品需作溶出速率试验。
Tolbutamide is an oral hypoglycemic drug. Due to its minimal solubility in water, gastrointestinal absorption after oral administration is limited by the rate of dissolution. As early as 1963, it was found that the tablets made of this medicine are clinically effective and some are ineffective. Levy through the dissolution test confirmed poor clinical efficacy of the tablet, the drug dissolution rate is also very slow. Also found that there are differences between the dissolution rate of different batches and different batches of tablets. Therefore, tolbutamide tablets have been listed as one of the bioavailability problems in foreign countries. The United States Pharmacopoeia 20 version of this product required dissolution rate test.