| 引用本文: | 伍志成,王学成*,徐诗军,王晓辉,岳鹏飞,伍振峰,易兵,杨明*.基于玻璃化转变理论的中药丸剂干燥裂纹形成分析及防控策略[J].中国现代应用药学,2023,40(4):554-561. |
| WU Zhicheng,WANG Xuecheng*,XU Shijun,WANG Xiaohui,YUE Pengfei,WU Zhenfeng,YI Bing,YANG Ming*.Analysis and Control Strategy of Drying Crack Based on Glass Transition Theory in traditional Chinese medicine pills[J].Chin J Mod Appl Pharm(中国现代应用药学),2023,40(4):554-561. |
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| 基于玻璃化转变理论的中药丸剂干燥裂纹形成分析及防控策略 |
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伍志成1, 王学成*1,2, 徐诗军1, 王晓辉1, 岳鹏飞1,2, 伍振峰1,2, 易兵3, 杨明*1,2
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1.江西中医药大学, 现代中药制剂教育部重点实验室, 南昌 330004;2.江西中医药大学, 创新药物与高效节能降耗制药设备国家重点实验室, 南昌 330004;3.江西赫柏康华制药设备有限公司, 南昌 330096
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| 摘要: |
| 干燥是中药丸剂生产过程重要工艺环节之一，干燥工艺合理控制是保障丸剂品质的关键。干燥过程外部条件影响丸剂内部水分的扩散和分布，进而影响丸剂组分的力学性质。丸剂裂纹是干燥过程由于组分力学性质发生改变而产生的典型问题，影响丸剂的外观、崩解和溶散时限。目前，尚未形成理论合理解释丸剂干燥裂纹形成过程，导致丸剂干燥高质量生产指导依据缺失。本文从丸剂的组分性质及成型过程角度，借助玻璃化转变理论，尝试分析了干燥中裂丸形成原因，介绍了丸剂玻璃化转变温度测定新技术和工艺调控干燥方法，以期为解决中药丸剂干燥裂丸问题提供参考。 |
| 关键词: 丸剂 干燥 玻璃化转变 裂丸 检测技术 防控策略 |
| DOI：10.13748/j.cnki.issn1007-7693.2023.04.020 |
| 分类号:R941 |
| 基金项目:国家自然科学基金项目(82003952，81760716)；江西省研究生创新专项资金(YC2021-S510)；中央引导地方科技发展资金项目(2022ZDD03085)；江西中医药大学科研基金资助项目(2022WBZR006) |
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| Analysis and Control Strategy of Drying Crack Based on Glass Transition Theory in traditional Chinese medicine pills |
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WU Zhicheng1, WANG Xuecheng*1,2, XU Shijun1, WANG Xiaohui1, YUE Pengfei1,2, WU Zhenfeng1,2, YI Bing3, YANG Ming*1,2
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1.Jiangxi University of Chinese Medicine, Key Laboratory of Modern Preparation of Traditional Chinese Medicine, Ministry of Education, Nanchang 330004, China;2.Jiangxi University of Chinese Medicine, State Key Laboratory of Innovation Drug and Efficient Energy-saving Pharmaceutical Equipment, Nanchang 330004, China;3.Jiangxi Hebai Kanghua Pharmaceutical Equipment Co., Ltd., Nanchang 330096, China
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| Abstract: |
| Drying is one of the important technological steps in the production of traditional Chinese medicine pills. The key to ensure the quality of pills lies on the reasonable control of drying technology. The diffusion and distribution of water in pill are affected by the external conditions during drying process, and the mechanical properties of pill components are also affected by the external conditions. Pill crack is a typical problem caused by the change of mechanical properties of pill components in drying process, which also affects pill appearance, disintegration and melting time. At present, there is no theory to explain the formation process of pill drying crack, which leads to the absence of guiding basis for the high-quality production of pill drying. In this paper, from the perspective of component properties and forming process of pills, and with the aid of glass transition theory, the formation reason of cracked pills during drying is analyzed, and the new technology of glass transition temperature measurement and process control drying method are analyzed, in order to provide reference for solving the problem of dried cracked pills of traditional Chinese medicine pills. |
| Key words: pill drying glass transition crack pill detection technology control strategy |
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