尿石颗粒的成型性工艺研究

Study on the Forming Technology of Urolite Granules

目的优选尿石颗粒的成型工艺条件。方法根据制粒难易程度初步优选出颗粒剂的最优辅料,再以辅料的成型性、吸湿性、休止角为考察指标,采用正交试验法优化辅料加入量、乙醇体积分数及辅料比例的工艺参数,并对制得的颗粒进行临界相对湿度考察。结果最佳成型工艺条件为浸膏粉与糊精配比为1∶0.9,乙醇的体积分数为90%,糊精与淀粉比为3.5∶1。为减少水分对药物性质及稳定性的影响,环境相对湿度应控制在72%以下。结论优选出的尿石颗粒成型工艺简单可行,为进一步工业化生产提供参考。

Objective To optimize the forming technology of Urolite granules.Methods According to the difficulty of granulation,the optimum excipients of granules are selected preliminarily.The orthogonal test is used to optimize the technological parameters of excipients addition,ethanol volume fraction and the proportion of excipients,and the critical relative humidity of the prepared granules is investigated.Results The optimum technological conditions are as follows:the ratio of extract powder to dextrin is 1∶0.9,the volume fraction of ethanol is 90%,and the ratio of dextrin to starch is 3.5∶1.To reduce the influence of water on the properties and stability of drugs,the relative humidity of environment should be controlled below 72%.Conclusion The optimized moulding process of Urolite granules is simple and feasible,and can provide reference for further industrialized production.