| 基于中药制药工程质量观的质量控制模式研究 |
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| 引用本文： | 伍振峰,林瑞华,王学成,张雨恬,王雅琪,罗小荣,刘振峰,朱卫丰,杨明. 基于中药制药工程质量观的质量控制模式研究[J]. 中国中药杂志, 2022, 0(1): 271-278 |
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| 作者姓名： | 伍振峰 林瑞华 王学成 张雨恬 王雅琪 罗小荣 刘振峰 朱卫丰 杨明 |
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| 作者单位： | 江西中医药大学现代中药制剂教育部重点实验室;江西中医药大学;江西中医药大学附属医院;江中药业股份有限公司;宜春万申制药机械有限公司 |
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| 基金项目： | 国家重点研发计划项目(2018YFC1707203);江西省5511重大专项(20182ABC28009);江西中医药大学“1050青年拔尖人才”项目(校字[2020]2号)。 |
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| 摘 要： | 由于中药材品种混乱、来源不一、化学成分复杂以及制剂工艺不规范、制药装备标准化程度不高等特点,现行的中药制剂质量控制模式和方法难以有效地控制和评价中药制剂的质量.该文围绕中药制剂质量控制现状,针对中药制剂质量控制存在的问题,提出中药制药工程质量观及控制中药制剂质量的策略.通过从"药材源头-制剂工艺-制药装备-中药制剂"全...
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| 关 键 词： | 中药制剂 量值传递 制剂工艺 制药装备 工程质量观 |
Quality control mode based on engineering quality view of Chinese medicine pharmacy |
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| WU Zhen-feng,LIN Rui-hua,WANG Xue-cheng,ZHANG Yu-tian,WANG Ya-qi,LUO Xiao-rong,LIU Zhen-feng,ZHU Wei-feng,YANG Ming. Quality control mode based on engineering quality view of Chinese medicine pharmacy[J]. China Journal of Chinese Materia Medica, 2022, 0(1): 271-278 |
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| Authors: | WU Zhen-feng LIN Rui-hua WANG Xue-cheng ZHANG Yu-tian WANG Ya-qi LUO Xiao-rong LIU Zhen-feng ZHU Wei-feng YANG Ming |
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| Affiliation: | (Key Laboratory of Modern Preparation of Traditional Chinese Medicine,Ministry of Education,Jiangxi Uniersit of Chinese Medicine,Nanchang 330004,China;State Key Laboratory of lnnovation Drug and Efficient Energy-Saving Pharmaceutical Equipment,Jiangxi University of Chinese Medicine,Nanchang 330004,China;Affliated Hospital of Jiangxi University of Chinese Medicine,Nanchang 330004,China;Jiangzhong Pharmaceutical Co.,Ltd.,Nanchong 330103,China;Yichun Wanshen Pharmaceutical Co.,Ltd.,Yichun 336000,China) |
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| Abstract: | Due to the characteristics of confusing varieties of Chinese medicinal materials,different sources,complex chemical composition,non-standard preparation process,and non-standard pharmaceutical equipment,the quality of Chinese medicinal preparations is difficult to be controlled and evaluated effectively under the current quality control mode and method of Chinese medicinal preparation.The present study proposed an engineering quality view of Chinese medicine pharmacy and a strategy to control the quality of Chinese medicinal preparations based on the current situation.The"overall,dialectical,and dynamic"multi-factor engineering quality view,covering original medicinal materials,preparation technologies,pharmaceutical equipment,and Chinese medicinal preparations,ensures the traceable process,measurable procedures,and feedback quality.The quality control mode of Chinese medicinal preparation with controllable sources,standardized preparation technologies,green pharmaceutical equipment,and intelligent manufacturing is built up. |
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| Keywords: | Chinese medicinal preparation quantity and value transfer preparation technology pharmaceutical equipment engineering quality view |
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