调整中药颗粒剂水分限度的研究  

Study on Moisture Limits of Traditional Chinese Medicine Granules

作　　者：陈晓颙 聂晶 张立群 李高[2] 

机构地区：[1]湖北省食品药品监督检验研究院,武汉430064 [2]华中科技大学同济药学院,武汉430030

出　　处：《中国药品标准》2015年第6期424-426,共3页Drug Standards of China

摘　　要：目的：对中药颗粒剂水分限度进行研究。方法：通过背景分析、企业调研及高水分样品进行稳定性试验等方面开展水分限度研究。结果：调研结果表明乳糖型及无糖型颗粒剂的水分较难控制在现行标准6．0％限度范围内；试验表明含水分7％-8％的样品稳定性较好。结论：建议在选用适宜的包装材料下，将中药颗粒剂的水分限度值放宽至8％，以适应工业药剂的发展。Objective： To study moisture limits of traditional Chinese medicine granules. Methods： The research was carried out by background analysis, enterprise survey and stability tests of high moisture samples. Results： It＇s difficult to control moisture within the working standard limit of 6. 0% for lactose and sugar free granules; The stability tests showed the samples with moisture of 7% -8% had a good stability. Conclusion： With appropriate packaging materials, the moisture limits of traditional Chinese medicine granules should be relaxed to 8% to adapt to the development of industrial chemicals.

关 键 词：中药颗粒剂 水分 限度 

分 类 号：R921.2[医药卫生—药学]