中国中药杂志

2017, v.42(19) 3826-3830

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中药制剂质量均一性的现状问题及保证策略研究
Status,problems and warranty strategy of quality uniformity for traditional Chinese medicine preparations

曾丽华,伍振峰,王芳,王学成,王雅琪,岳鹏飞,万娜,林环玉,杨明
ZENG Li-hua,WU Zhen-feng,WANG Fang,WANG Xue-cheng,WANG Ya-qi,YUE Peng-fei,WAN Na,LIN Huan-yu,YANG Ming

摘要(Abstract):

中药制剂质量的稳定均一性是保证临床用药安全有效的基础。目前,我国中药制剂的质量参差不齐,不同生产厂家的同一中药制剂、同一生产厂家同一中药制剂,甚至同一厂家同品种的不同批次之间的中药制剂质量差异都较大,达不到稳定均一。该文通过查阅中药制剂质量控制等相关文献,从中药制剂质量现状和问题分析出发,探讨制药全过程影响质量均一的可能因素,并提出中药种植规范化、炮制规范化、制药设备标准化、混批投料、质量源于设计等策略,以期为保证中药制剂质量稳定均一提供参考。
The quality uniformity of traditional Chinese medicine( TCM) preparation is the base for guaranteeing the safety and effectiveness of clinical medication. At present,the quality of TCM preparation is uneven. At present,the same TCM preparation in different manufacturers,TCM preparations in the same manufacturer,and even different batches of a same TCM preparation in the same manufacturer have great differences in quality,which can not reach stability and uniformity. This paper would discuss the possible factors that influence the uniformity of quality in the whole process of pharmacy by means of consulting relevant literature on quality control of Chinese herbal preparations and analyzing the present situation and problems of the quality of TCM preparation. In addition,some strategies such as standardization of cultivation of TCM,processing standardization,standardization of pharmaceutical equipment,mixed batch feeding,and Quality by Design would be also put forward to provide references for the quality uniformity of TCM preparation.

关键词(KeyWords): 中药制剂;质量均一性;现状及问题;保证策略
traditional Chinese medicine preparation;quality uniformity;status and problems;warranty strategy

Abstract:

Keywords:

基金项目(Foundation): 国家自然科学基金项目(81760716);; 江西民族传统药现代科技与产业发展协同创新中心开放基金项目(JXXT201403017)

作者(Author): 曾丽华,伍振峰,王芳,王学成,王雅琪,岳鹏飞,万娜,林环玉,杨明
ZENG Li-hua,WU Zhen-feng,WANG Fang,WANG Xue-cheng,WANG Ya-qi,YUE Peng-fei,WAN Na,LIN Huan-yu,YANG Ming

DOI: 10.19540/j.cnki.cjcmm.20170907.013

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