干法制粒技术在连花清瘟胶囊生产中应用.docVIP

干法制粒技术在连花清瘟胶囊生产中应用 　　摘要：目的 采用干法制粒工艺制备连花清瘟胶囊的颗粒，解决原工艺结块现象。方法 以制粒的难易程度和颗粒收率为考察指标，优选干法制粒中最优辅料及辅料用量，采用正交试验设计对干法制粒工艺参数进行优化，并与湿法制粒工艺的颗粒得率、休止角、堆密度进行对比。结果 选择淀粉为辅料，最佳干法制粒工艺为轧辊压力12 MPa、轧辊转速5 r/min、送料速度10 r/min。干法制粒工艺颗粒得率明显高于湿法制粒。结论 干法制粒工艺可有效改善连花清瘟胶囊制粒中出现的结块现象，适用于连花清瘟胶囊的制粒工艺。 　　关键词：连花清瘟胶囊；干法制粒技术；工艺优化；对比研究 　　DOI：10.3969/j.issn.1005-5304.2015.04.021 　　中图分类号：R283.5 文献标识码：A 文章编号：1005-5304（2015）04-0074-03 　　Application of Dry Granulation Technology in Production of Lianhua Qingwen Capsules WANG Yu-feng， LI Chun-rui， LI Song， OUYANG Yue， FAN Wen-cheng， LIU Min-yan （Shijiazhuang Yiling Pharmaceutical Co. Ltd.， Shijiazhuang 050035， China） 　　Abstract：Objective To solve the agglomeration problem in the former process， dry granulation technology was used to prepare the granules of Lianhua Qingwen Capsules. Methods Complexity and granule yield coefficient were set as inspection indexes. The optimum subsidiary material and its amount were optimized. The parameters of dry granulation technology were optimized by orthogonal test. Then， granule yield， angle of repose， and bulk density were compared with those of wet granulation technology. Results Starch was set as subsidiary material. The optimum technology is roll pressure of 12 MPa， rotation speed of 5 r/min， and feed speed of 10 r/min. The yield of granules prepared by dry granulation technology was significantly higher than that of wet granulation technology. Conclusion The dry granulation technology can effectively improve the agglomeration of the granulation process of Lianhua Qingwen Capsules， and was suitable for granulating process of Lianhua Qingwen Capsules. 　　Key words：Lianhua Qingwen Capsules；dry granulation technology；technology optimization；comparative study 　　连花清瘟胶囊由连翘、金银花、麻黄、鱼腥草等中药组成，具有清瘟解毒、宣肺泄热的作用，用于治疗流行性感冒[1]。连花清瘟胶囊原制粒工艺采用高速搅拌湿法制粒技术，容易出现结块现象，颗粒需要二次烘干，影响药效成分的稳定性。相对于湿法制粒技术，干法制粒工艺无需湿润、混合、干燥等过程，所得颗粒大小均匀、流动性好、可压性好，工艺简便，能有效 　　基金项目：国家科技重大专项-重大新药创制（2011ZX09201- 201-27） 　　通讯作者：刘敏彦，E-mail：liuminyan75@163.com 　　保证产品质量[2-8