复方薏蓝颗粒的制粒工艺分析

Analysis on the granulating process of Compound Yilan Granula

目的分析建立复方薏蓝颗粒剂的制粒最佳生产工艺条件。方法采用正交试验法对复方薏蓝颗粒制剂在制粒生产过程的影响因素,即物料干燥温度、浸膏相对密度、入塔风温、喷雾液频率等进行因素考察分析,同时以颗粒含水量、颗粒均匀度、生产效率为指标进行检查分析。优选该制剂的制粒最佳工艺条件。结果综合评价试验过程中的各项指标,复方薏蓝颗粒制剂喷雾干燥法制粒的最佳工艺条件为物料干燥温度为55～60℃、入塔风温为175～180℃、喷雾液频率为7.00Hz、浸膏相对密度为1.06～1.10。结论根据中试生产结果分析,通过正交试验法优选的工艺条件用于生产,制成的颗粒各项指标均符合《中国药典》的规定,制剂质量稳定。

Objective To analyse the best production conditions of granulating process of Compound Yilan Granula.Methods Production factors of Compound Yilan Granula in the granulating process such as drying temperature of material,relative density of extracts,wind temperature into the tower,frequency of spray and so on were investigated and analyzed by the orthogonal test,which were examined and analyzed with the index including moisture content and uniformity of granula,production efficiency.The best production conditions were chosen.Results Indexs in the test process were given a overall evaluation,Compound Yilan Granula made by spray drying method had the best production conditions with drying temperature of material was 55-60℃,wind temperature into the tower was 175-180℃,frequency of spray was 7.00 Hz,relative density of extracts was 1.06-1.10.Conclusion According to the results,every indexes of Compound Yilan Granula meet the provisions of China pharmacopoeia with the best production conditions chosen by the orthogonal test,preparation is stable.