桂栀助眠胶囊成型工艺研究

杜正彩　齐彪　张明哲　韦燕霞　李丽洁　郝二伟　侯小涛　胡小勤　邓家刚

摘要：目的  篩选桂栀助眠胶囊的最佳成型工艺。方法  以吸湿率和休止角为评价指标，筛选出适当的辅料，并对主药与辅料的比例进行优化;以制粒情况、颗粒收得率和成型率为指标，筛选出最佳乙醇浓度;考察颗粒的吸湿率、休止角、堆密度、临界相对湿度。结果  最佳成型工艺为：主药与微晶纤维素、可溶性淀粉按6∶3∶1比例混匀，加入75%乙醇制软材，过24目筛制粒，真空干燥（0.08～0.1 MPa，60 ℃）4 h，整粒。所得颗粒休止角为29.30°，吸湿率为8.95%，堆密度为0.444 8 g/mL，临界相对湿度为74.27%。结论  本研究所得成型工艺合理、可行，可为桂栀助眠胶囊大生产提供依据。

关键词：桂栀助眠胶囊;成型工艺;吸湿率;休止角;堆密度;临界相对湿度

中图分类号：R285.5    文献标识码：A    文章编号：1005-5304（2019）09-0080-05

Study on Forming Process of Guizhi Sleeping Capsules

DU Zhengcai¹， QI Biao²， ZAHNG Mingzhe¹， WEI Yanxia²， LI Lijie²， HAO Erwei³， HOU Xiaotao²， HU Xiaoqin²， DENG Jiagang³

1. Science Experimental Center of Guangxi University of Chinese Medicine， Nanning 530001， China; 2. School of Pharmacy， Guangxi University of Chinese Medicine， Nanning 530001， China; 3. Guangxi Key Laboratory of Efficacy Study on Chinese Materia Medica， Nanning 530001， China

Abstract： Objective To optimize the forming process of Guizhi Sleeping Capsules. Methods With hygroscopicity and the angle of repose as the evaluation indexes， the appropriate excipients were screened out， and the proportion of main medicine and excipients were optimized. With granulation condition， particle yield and molding rate as indicators， the optimal ethanol concentration was screened out; and the moisture absorption rate， repose angle， bulk density and critical relative humidity of particles were investigated. Results The optimal molding process was that the powder was mixed with microcrystalline cellulose-soluble starch （6：3：1）; 75% ethanol was added to make soft material， granulated in 24 meshes， dried in vacuum （0.08–0.1 MPa， 60 ℃） for 4 hours; the whole granule was obtained. The repose angle of the granule was 29.30°; the moisture absorption rate was 8.95%; the bulk density was 0.444 8 g/mL; and the critical relative humidity was 74.27%. Conclusion The forming process is reasonable and feasible， and can provide basis for the production of Guizhi Sleeping Capsules.