| 调整中药颗粒剂水分限度的研究 |
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| 引用本文： | 陈晓颙,聂晶,张立群,李高.调整中药颗粒剂水分限度的研究[J].中国药品标准,2015,16(6):424-426. |
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| 作者姓名： | 陈晓颙 聂晶 张立群 李高 |
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| 作者单位： | 湖北省食品药品监督检验研究院, 武汉 430064,湖北省食品药品监督检验研究院, 武汉 430064,湖北省食品药品监督检验研究院, 武汉 430064,华中科技大学同济药学院, 武汉 430030 |
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| 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。
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| 关 键 词： | 中药颗粒剂 水分 限度 |
| 收稿时间： | 2015/5/29 0:00:00 |
| 修稿时间： | 2015/9/17 0:00:00 |
Study on Moisture Limits of Traditional Chinese Medicine Granules |
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| Authors: | Chen Xiaoyong Nie Jing Zhang Liqun and Li Gao |
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| Institution: | Hubei Institute for Food and Drug Control, Wuhan 430064,Hubei Institute for Food and Drug Control, Wuhan 430064,Hubei Institute for Food and Drug Control, Wuhan 430064 and Tongji College of Pharmacy, Huazhong University of Science and Technology, Wuhan 430030 |
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| Abstract: | 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. |
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| Keywords: | traditional Chinese medicine granules moisture limit |
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