益心舒胶囊防潮性能改进的研究.docVIP

益心舒胶囊防潮性能改进的研究 　　摘要：目的 考察防潮辅料及内容物形态对益心舒胶囊吸湿性的影响，改善益心舒胶囊防潮性能。方法 以吸湿率和临界相对湿度为指标，比较可溶性淀粉、玉米淀粉、糊精、乳糖、甘露醇、磷酸氢钙、乙基纤维素、微晶纤维素、羟丙甲纤维素和低取代羟丙纤维素10种辅料对益心舒胶囊内容物吸湿性的影响，考察优选辅料与胶囊内容物制粒后对益心舒胶囊吸湿性的影响。结果 益心舒胶囊内容物的平衡吸湿率为18.04%，其最佳的防潮辅料为乳糖、微晶纤维素和甘露醇，药辅比为1∶0.1（wt%），制粒前其平衡吸湿率分别为14.87%、14.39%、15.38%，制粒后其平衡吸湿率分别为10.75%、10.29%、11.13%。结论 筛选出的防潮辅料能有效降低药粉的吸湿性，制粒后可有效提高益心舒胶囊的防潮性。 　　关键词：益心舒胶囊；辅料；吸湿性；吸湿率；临界相对湿度 　　DOI：10.3969/j.issn.1005-5304.2017.09.017 　　中图分类号：R283.5 文献标识码：A 文章编号：1005-5304（2017）09-0068-05 　　Study on Improving Moisture Resistance of Yixinshu Capsule LI Zhen-zhen， WANG Jie， YI Hong， ZANG Chen， ZHAO Qing-he， CHEN Yan-jun （Institute of Chinese Materia Medica， China Academy of Chinese Medical Sciences， Beijing 100700， China） 　　Abstract： Objective To investigate the effects of moisture-proof materials and contents on hygroscopicity of Yixinshu Capsules； To improve moisture-proof function of Yixinshu Capsules. Methods The hygroscopicity performance of Yixinshu Capsules was analyzed with the indexes of moisture absorption rate and critical relative humidity （CRH）， and effects of soluble starch， maize starch， dextrin， lactose， mannitol， calcium hydrogen phosphate， ethylcellulose， microcrystalline cellulose， hypromellose and low-substituted hydroxypropyl cellulose on hygroscopicity of Yixinshu Capsules were compared. The effects of optimized excipients and capsule contents after granulation on hygroscopicity of Yixinshu Capsules were tested. Results Lactose， microcrystalline cellulose and mannitol were the most appropriate moisture-proof excipients for Yixinshu Capsules with balanced moisture absorption rate of 18.04%， for which the best proportion of Yixinshu Capsules to excipients was 1 to 0.1 （wt%）. The balanced moisture absorption rate of the powders were 14.87%， 14.39%， and 15.38%， respectively， whereas the granules were 10.75%， 10.29%， and 11.13%， respectively. Conclusion The selected excipients can effectively reduce the hygroscopic rate of the Yixinshu Capsules， and its granu