不同辅料对愈痫灵颗粒所用原料(干膏粉)吸湿性的影响

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

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。

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, ttygroscopic rates were determined and com- pared. 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.