麻黄复配胶软胶囊的制备及其稳定性研究  

Investigation into the preparation and stability of mixed gel soft capsules of Ephedrae herba

作　　者：杨济昆[1] 张素阳[1] 刘建平[1] 郑文杰[1] 

机构地区：[1]中国药科大学药物制剂研究所,南京210009

出　　处：《药学服务与研究》2012年第5期366-369,共4页Pharmaceutical Care and Research

基　　金：国家科技重大专项重大新药创制资助项目(No.2009ZX9310-004);国家中医药管理局中医药科学技术研究专项(No.06-07ZP20)

摘　　要：目的:探讨提高麻黄软胶囊稳定性的方法。方法:明胶与羟丙基甲基纤维素(HPMC)复配作为软胶囊的囊壳材料,减少明胶交联反应。采用中心复合试验设计,优选复配胶的处方和工艺,测定复配胶的凝胶性质,并进行复配胶软胶囊的稳定性考察。结果:复配胶处方确定为明胶(冻力180g)、明胶(冻力240g)、HPMC、甘油、水用量比为49∶26∶25∶30∶200,复配软胶囊胶凝时间5.72min,崩解时限4.6min,加速90d的崩解时限11.2min,加速90d的累积溶出百分率86.6%。结论:明胶-HPMC复配可以提高麻黄软胶囊的稳定性。Objective： To investigate the method of improving the stability of Ephedrae herba soft capsules. Methods： The Ephedrae herba soft capsules were prepared by mixed gel of gelatin and hydroxypropyl methylcellulose（HPMC） as shell compo sition of the soft capsule in order to reduce the gelatin cross linked reaction. The prescription and methodology of the mixed gel were optimized by central composite design. The gel properties of mixed gel were determined and the stability of mixed gel soft capsules was also studied. Results： The prescription of the mixed gel was as follows： gelatin（bloom 180 g） ： gelatin（bloom 240 g） ： HPMC ： glycerin = water= 49 ： 26 ： 25 ： 30 ： 200. Gelling time of the mixed gel soft capsules was 5. 72 rain. The time limit of disintegration was 4. 6 min and the time limit of accelerated 90 days was 11. 2 rain. Dissolution rate when accelerated 90 days was 86.6~. Conclusion： Gelatin-HPMC mixtures can improve the stability of the Ephedrae soft capsule.

关 键 词：麻黄 软胶囊 稳定性 复配胶 

分 类 号：R944.5[医药卫生—药剂学]