新型水溶性润滑剂亮氨酸与PEG6000组合物的研究

A new water-soluble lubricant of tablets-L-leucine combined with PEG6000

目的:制备一种水溶性与润滑性良好的润滑剂。方法:制备共喷润滑剂[亮氨酸和聚乙二醇6000(PEG6000)按比例溶解后通过喷雾干燥法制备]、筛混润滑剂(单喷亮氨酸和PEG6000粉碎后的过筛混合物),硬酯酸镁、亮氨酸、PEG6000、硬脂富马酸钠、氯化钠分别粉碎过筛。以推片力、黏冲情况、崩解时间和溶液的外观为指标对各种润滑剂润滑效果和制剂性质进行评价。测定各种润滑剂的基本物性,用X射线衍射仪、傅里叶红外光谱仪、差示扫描量热仪和电子扫描显微镜分析共喷润滑剂制备前后化学成分和晶型变化。结果:共喷润滑剂对比其他几种润滑剂更适合作为泡腾片的润滑剂。共喷润滑剂在喷雾干燥制粒前后的化学成分和晶型没有改变,润滑效果的提高可能是由于颗粒外部形态的改变。结论:共喷润滑剂拥有较好的水溶性和润滑作用,是一种良好的水溶性润滑剂。

Objective： To prepare an effective and water-soluble lubricant. Method： Co-sprayed lubricant （L-leucine and po- lyethylene glycol 6000 co-sprayed according to a certain proportion） and mixed lubricant （the physical mixture of spayed L-leucine and crushed polyethylene glycol 6000） were prepared and polyethylene glycol 6000, L-leucine, magnesium stearate, sodium stearyl fumar- ate and sodium chloride are crushed and sieved, respectively. Residual force, appearance of solution and disintegration time were con- sidered as response variables of the lubrication effect to evaluate different lubricants. The changes of the co-sprayed lubricant were stud- ied by differential scanning calorimetry, fourier infrared, electronic scanning microscope and X-ray diffraction. Result： The efficacy of co-sprayed lubricant is better than other lubricants. Efficacy is improved by external form change without inner components and crystal changes. Conclusion： Co-sprayed lubricant is a good water soluble tablet lubricant which has zood efficaev.