Method for measuring dissolution rate of spironolactone tablets

• Main Author: BIAN XIAOLONG
• Format: Patent
• Language: Chinese; English
• Published: 24.04.2018
• Subjects: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES; MEASURING; PHYSICS; TESTING

The invention relates to methods for measuring the in-vitro dissolution rate of drug solid preparations, in particular to a method for measuring the dissolution rate of spironolactone tablets. The method includes the steps of firstly, preparing 15L of dissolution medium, taking 12 generic spironolactone tablets and 12 original spironolactone tablets, adding into a 12-cup intelligent dissolution tester, and setting a method, wherein a 75r/min stirring paddle method is used, dissolution volume is 1000ml, and sampling points 10min, 15min, 20min, 30min, 45min, 60min, 90min and 120min; secondly, sampling at the sampling points to measure the dissolution quantity of spironolactone, comparing the dissolution quantity, at each sampling point, of the two kinds of tablets, and calculating an f2 factor. 本发明涉及种药物固体制剂体外溶出度的测定方法，特别涉及种螺内酯片剂溶出度的测定方法，所述方法，步骤如下：步骤1，配制15L溶出介质，分别取螺内酯仿制片和原研片各12片，投入12杯的智能溶出仪中，设置方法：浆法75r/min，1000ml为溶出体积，取样点分别为10min、15min、20min、30min、45min、60min、90min、120min。步骤2，分别于上述取样点取样进行螺内酯溶出量测定，比较两种片剂每个取样点的溶出量，