优化参芪阿胶胶囊生产工艺研究

Studies on the Optimized Production Technology of ShenQiAJiao Capsule

目的优化参芪阿胶胶囊生产工艺研究。方法考察不同辅料及其配比对参芪阿胶胶囊内容物吸湿性的影响;以优化后工艺制备的颗粒的休止角、堆密度、临界相对湿度为考察指标,筛选出合理生产工艺条件。结果表明选择"糊精+乳糖+淀粉+微晶纤维素(0. 0375∶0. 0375∶0. 0375∶0. 0375)"方案辅料配比最为合理,崩解剂选择交联聚维酮最佳,可在15min内完全崩解;制得内容物(颗粒)抗湿能力强,流动性好,临界相对湿度80%,堆密度为0. 6533g·mL^(-1)。结论该优化生产工艺制备的胶囊剂符合质量要求,可全面提升参芪阿胶胶囊的内在品质,为增强产品市场竞争力提供了科学依据。

OBJECTIVE To study on the optimized production technology of ShenQiAJiao capsule. METHODSBy investigating the eft）cts of dirt）rent excipients and their proportion on hygroscopicity of shenqi capsule, we selected the reasonable production process conditions, by using the angle of repose, heap density and critical relativehumidity. RESULTS The results showed that ＂ dextrin lactose ＋ lactose ＋ starch ＋ microcrystalline cellulose（0. 0375 ： . 0375 ： 0. 0375 ： 0. 0375 ） ＂ package accessories matched the most reasonable, disintegrating agentcrosslinked povidone best choice ,which can be completely in 15 minutes ;with the powerful granule anti-moisture ability,good liquidity,keeping the critical relative humidity at 80% ,and the heap density is 0. 6533 g · mL-1. CON-CLUSION The optimized production process of the capsule meets the quality requirements,which can comprehensively improve the inner quality of ginsen-gand astragal capsule and provide scientific basis for enhancing the marketcompetitiveness of products.