正文 基於組分結構理論的膽木注射液多維結構質量控製技術體係(3 / 3)

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Multi-dimensional structure quality control technology system of

Danmu injection based on component structural theory

YIN Rong1,2, ZHU Fen-xia1, LI Xiu-feng3, JIA Xiao-bin1*,

(1、Key Laboratory of New Drug Delivery System of Traditional Chinese Medicine under

State Administration of Traditional Chinese Medicine, Jiangsu Provincial Academy of Chinese Medicine, Nanjing , China;

2、 Department of Analytical Chemistry, China Pharmaceutical University, Nanjing , China;

3、 Engineering Center for Li Nationality Medicines, Hainan Pharmaceutical Factory Co、, Ltd、, Wuzhishan , China)

[Abstract] Danmu is one of common medicines in folks of Li nationality, with such effects in clearing heat and removing toxicity, antisepsis and anti-inflammation、 Danmu injection, which is developed with Danmu herbs, has been clinically applied for years and showed curative efficacy、 Currently, though many studies have been conducted to analyze chemical constituents in Danmu in details, its pharmacodynamic material basis related to disease prevention and treatment has not been defined、 Furthermore, as the quality control methods for Danmu and its preparations remain restricted to single index component and irrational to some extent, it fails to ensure their inherent quality、 On the basis of the summary of previous study results, as well as the "component structural theory" of the material basis, we established a "multi-dimensional structure quality control technology system" that is capable of reflecting the integrity of effects of Danmu injection and component structure hierarchy, and performed a dynamic monitoring over the whole process from medicinal materials and preparation products, so as to ensure the inherent quality of Danmu injection、

[Key words] Danmu injection; material basis; component structure theory; multi-dimensional structure quality control

doi:10.4268/cjcmm

[責任編輯曹陽陽]