不同辅料对愈痫灵颗粒所用原料(干膏粉)吸湿性的影响

 目的筛选愈痫灵颗粒成型工艺中防潮性最佳的辅料,为工业化生产提供依据。方法通过测定干膏粉及其与不同辅料的混合物的吸湿速度、临界相对湿度(CRH),建立动力学模型,提取吸湿速度参数并比较大小。结果经数学处理及统计学分析可知干浸膏、辅料与干膏粉的混合物的吸湿动力学模型符合希古契(Higuchi)方程,通过比较吸湿速度常数K(Higuchi系数)得到防潮性最佳的辅料种类为乳糖与β-环糊精的混合物,配比为干膏粉-辅料=4∶1;辅料中乳糖-β-环糊精=1∶2。结论优良的辅料可使吸湿速度减慢,CRH增大,从而显著地提高了该制剂的稳定性,有利于生产、贮存、运输及应用。

Influence of Different Excipients on Hygroscopic Property of Raw Material (Dry Extract Powder) in Yuxianling Granules

OBJECTIVE To screen optimum damp-proof excipients which is used in plastic process of Yuxianling granules,in order to provide a basis for industry-scale produce.METHODS By determining hygroscopic rate of dry extract powder and mixed-powder(dry extract powder with different excipients)and CRH,dynamics model was established.Hygroscopic rates were determined and compared.RESULTS The hygroscopic dynamics model met Higuchi equation.By comparing hygroscopic rate constant K(Higuchi coefficient),the optimized damp-proof excipient was obtained as the mixture of lactose and β-cyclodextrin with the ratio of 1∶2.The ingredient ratio of dry extract powder to excipients(mixture)was 4∶1.CONCLUSION Good excipients greatly raise stability of this preparation by decreasing hygroscopic rate and increasing CRH.It is beneficial for production,storage,transport and application.