乳糖粉体学性质的初步探讨

The primary investigation and study on micromeritic characteristics of lactose

测定 5种型号乳糖产品的粒度分布、松密度、摇实密度、休止角、流速及成形性 ,确定何种乳糖适合用作直接压片辅料。以双氯芬酸钾为模型药物 ,用各型号乳糖为填充剂直接压片 ,制得双氯芬酸钾片 ,测定所得片子的硬度、脆碎度和片重差异。结果显示 :粒度以GranuLac 2 0 0最细 ,其他几种差不多 ;流动性以GranuLac 2 0 0最差 ,GranuLac 70次之 ,其他三种相差不大 ,成形性以Cellactosc 80最好 ,Tablettose70次之 ,CapsuLac 80最差。综合各项粉体学性质 ,Cellactose80和Tablettose 70较适合用作直接压片的辅料。用以上各型号乳糖作填充剂直接压片制得双氯芬酸钾片 ,其压片结果与上述测定结果基本相符 。

To difine which kind of lactose can be used as direct compression excipients, the size distribution, aerated density, tapped density, repose angle, flow rate and compactibility of five kinds of lactose were evaluted. The diclofenac potassium tablets were prepared by direct compression, using the five kinds of lactose as the diluent. The hardness, fragility and weight variation of the tablets were evaluted. Results: The particle size of GranuLac 200 were smallest. The others were basically the same. The flowability of GranuLac 200 was the worst and of GranuLae 70 was the second worst.The rest were basically the same. The compactibility of Cellactose 80 was the best and of Tablettose 70 was the second best, of CapsuLae 60 was the worst.In consideration of micromeritic characteristies,Cellactose 80 and Tablettose 70 were suitable to be used as direct compression excipients. Using five kinds of laetose as dituent to prepare diclofenac potassium tablets,the results were the same as that mentioned above. The study results show that the determination of test items of micromeritic characteristies may be used as guidance for the choice of excipients.