雪莲总黄酮胶囊的成型工艺优选

Optimization of Molding Technology of Saussurea involucrata Total Flavonoids Capsule

目的:确定雪莲总黄酮胶囊最优成型工艺条件,为其工业化生产提供依据。方法:以休止角、吸湿率、堆密度、临界相对湿度为考察指标,对辅料种类(乳糖、β-环糊精、可溶性淀粉、微粉硅胶、微晶纤维素)及辅料加入量进行筛选,确定最优成型工艺条件并进行验证试验。结果:以微粉硅胶为辅料所制处方颗粒的休止角和吸湿率结果更符合要求,其最佳加入量为10.0%(与雪莲总黄酮浸膏配比为1∶9),选用0号胶囊。颗粒的临界相对湿度为62%,最优成型工艺条件所制3批样品颗粒的休止角为31.8°、堆密度为0.308 5 g/ml、临界相对湿度为62.13%、崩解时限为18.67 min、水分为7.8%(RSD≤1.15%,n=3),均符合胶囊的质量要求。结论:本试验确定的成型工艺操作简单、方便可行,适合工业化生产。

OBJECTIVE： To provide reference for industrial production of Saussurea involucrata total flavonoids capsule by de- termining the optimal molding technology. METHODS： Using angle of repose, moisture absorption rate, bulk density and critical relative humidity （CRH） as index, the types （lactose, β-cyclodextrin, soluble starch, micronization silica gel, microcrystalline cel- lulose） and amounts of excipients were screened to determine optimal molding technology, and validation test was also performed. RESULTS： The particles which were prepared using micronization silica gel as excipient were more in line with the requirements. The optimal technology was as follows as micronization silica gel 10.0% （ratio of it to S. involucrata total flavonoids extractum of 1：9）, No. 0 capsule, CRH 62%. In the validation study of 3 batches of samples prepared by optimal molding technology, the fol- lowing conditions all met the requirements of capsules. The angle of repose was 31.8° ; the bulk density was 0.308 5 g/ml; CRH was 62.13% ; disintegration time was 18.67 min; moisture was 7.8% （all RSDs≤l.15%, n=3）. CONCLUSIONS： The molding technology is simple, convenient, feasible, and suitable for industrial production.