• Zhongguo Zhong Yao Za Zhi · Oct 2017

    [Status, problems and warranty strategy of quality uniformity for traditional Chinese medicine preparations].

    • Li-Hua Zeng, Zhen-Feng Wu, Fang Wang, Xue-Cheng Wang, Ya-Qi Wang, Peng-Fei Yue, Na Wan, Huan-Yu Lin, and Ming Yang.
    • State Key Laboratory of Innovation Drug and Efficient Energy-Saving Pharmaceutical Equipment, Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, China.
    • Zhongguo Zhong Yao Za Zhi. 2017 Oct 1; 42 (19): 3826-3830.

    AbstractThe 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.Copyright© by the Chinese Pharmaceutical Association.

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