流化床喷雾成粒和摇摆式挤出制粒法对复方丹参片制备用颗粒可压性的影响(1)
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[摘要] 目的：探讨流化床喷雾成粒和摇摆式挤出制粒法对复方丹参片制备用颗粒可压性的影响。方法：分别采用流化床喷雾成粒和摇摆式挤出制粒法制备复方丹参片制备用颗粒，用德国85冲Krosh高速压片机试压。结果：流化床喷雾制粒颗粒圆整、类球形，粒径分布较窄，多为14～24目，颗粒细腻，流动性好，颗粒强度较大，压缩度小，收率高，工序耗时仅2.5 h；在设定16 kN片冲压力下85冲Krosh高速压片机压片，流化床颗粒和摇摆式制粒压片硬度、脆碎度无显著性差异，但压片速度有显著性差异。结论：流化床喷雾成粒在片剂制备工艺上有明显优势，值得进一步推广。
[关键词] 流化床喷雾成粒；摇摆式挤出制粒法；复方丹参片
[中图分类号] R943[文献标识码] A [文章编号] 1673-7210(2010)11(b)-053-02
Analysis on the compressibility of granulas for Compound Salvia Tablets preparation by fluidized bed spraying granulation method and wagging extrusion granulation method
ZHAO Wenchang, SONG Lijun
(School of Pharmcy, Guangdong Medical College, Dongguan 523808, China)
[Abstract] Objective: To investigate the effect of different granulation methods on the compressibility of granulas for Compound Salvia Tablets. Methods: Fluidized bed spraying granulation method and wagging extrusion granulation method were employed and compressed tablets using 85 pounch Krosh tablet machine. Results: The particles prepared by fluidized bed spray granulation were globularlike with a narrow particle size distribution (14-24 mesh). Furthermore, the advantages of fluidized bed spray granulation were the superior fluidity, compressibility, and high granula yield with mere 2.5 h production process. There was obvious difference in compressing speeds for two granulation methods prepared by 85-pounch Krosh high speed tablet machine without obvious difference in hardness and friability of Tablets. Conclusion: The fluidized bed spraying granulation method is reasonable and reliable with high stability and reproducibility in tablets compression.
[Key words] Fluidized bed spraying granulation method; Wagging extrusion granulation method; Compound Salvia Tablets
复方丹参片由丹参、三七、冰片三味中药组成， 具有活血化瘀、理气止痛等功效，用于气滞血瘀所致的胸痹，心悸、心前区疼痛以及冠心病心绞痛见上述诸症[1]。传统的制备工艺采用丹参水、醇提取后，摇摆式挤出法制粒-干燥-整粒-压片-包衣-包装等工序，该湿法制粒工序繁琐，干燥时间较长，冰片在干燥过程中损失较大且易污染，生产效率较低。流化喷雾制粒又称一步制粒，该系统将混合、制粒和干燥三道工序集成在一个装置中完成，制得颗粒大小均匀、外形圆整、流动性好，生产效率高，便于自动控制，同时由于制粒过程在密闭的制粒机内完成，生产过程不易被污染，已广泛应用于口服固体制剂的制粒生产中[2-5]。笔者在进行固体制剂GMP的改造中，采用流化喷雾制粒工艺制备复方丹参片颗粒，成功进行了制粒工艺的技术革新，现介绍如下：
1 仪器与试药
摇摆式制粒机(上海天凡药机制造厂)；PGL-10型喷雾干燥制粒机(容器直径1.5 m，每次投料150 kg，重庆广厦干燥设备工程公司)；85冲Krosh压片机(德国Krosh公司)；SCSF型系列直线振动筛(新乡市首创机械有限公司)；鼓风干燥箱(常熟制药机械厂有限公司)；78X-6A型片剂四用仪(上海黄海药检仪器公司)；复方丹参浸膏(批号：061012 ......
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