达美康溶出度测定方法的研究

STUDY ON DISSOLUTION TEST OF DIAMICRON

采用转篮法对达美康(甲磺吡脲片)进行溶出度测定试验,以磷酸盐缓冲液(pH8.60)含30%乙醇1000ml为溶剂,转篮法转速为150r/min,规定1h的溶出量不得少于标示量的50%,3h的溶出量不得少于标示量的75%,并用美国Hanson药物溶出仪与天津药物溶出仪进行比较实验,两台仪器无显著差异。本文方法可控制产品质量。

Dissolution rate of diamicron was determined by rotating basket method using 1000ml 30% alcoholic phosphate buffer solution of pH 8.6 as the dissolution medium,with a speed of 150 r/min.The requirements of the test are:not less than 50% of the labeled amount is dissolved in 1 hour and not less than 70% of the labeled amount is dissolved in 3 hours.Both Hanson dissolution apparatus and Tianjin dissolution apparatus have been used without significant difference in results.