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将《中国药典》中的化学指标提升为生物活性指标以实现中药生物标准化的方法建立。

Method establishment for upgrading chemical markers in pharmacopoeia to bioactive markers for biological standardization of traditional Chinese medicine.

作者信息

Lau Clara Bik-San, Yue Grace Gar-Lee, Lau Kit-Man, Chan Yuk-Yu, Shaw Pang-Chui, Kwok Hin-Fai, Wong Lok-Sze

机构信息

Institute of Chinese Medicine, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong.

State Key Laboratory of Phytochemistry and Plant Resources in West China, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong.

出版信息

J Tradit Complement Med. 2018 Sep 12;9(3):179-183. doi: 10.1016/j.jtcme.2018.09.003. eCollection 2019 Jul.

Abstract

Quality surveillance on authentication, safety and efficacy of proprietary Chinese medicines (pCm) are certainly the top priorities for the industries. Nowadays, the quality control system adopted is mainly chemical marker-oriented, concerning basically the correct use of raw material and safety issues, while the biological activities of the chemical marker(s) are seldom considered. Hence, there is an undefined relationship between the amount of chemical markers and the claimed pharmacological activities. In view of the need in identifying appropriate markers for biological standardization of pCm products, the present study aimed to establish a systematic methodology for verifying whether the chemical marker of a traditional Chinese medicine (TCM) listed in Chinese Pharmacopoeia could be upgraded to a bioactive marker with certain efficacy in treating a particular disease. Our proposed methodology included a series of work on extraction, quantification, literature search and pharmacological experiments, in which the water extractability, biological effects at theoretical dose and oral bioavailability of the candidate chemical markers were all taken into consideration. The feasibility and implication of this bioactive markers verification methodology were further elaborated. Our findings will serve as the foundation for further research and development of biological standardization of TCM.

摘要

中成药的鉴别、安全性和有效性的质量监管无疑是该行业的首要任务。如今,所采用的质量控制体系主要以化学标志物为导向,基本关注原材料的正确使用和安全问题,而很少考虑化学标志物的生物活性。因此,化学标志物的含量与所宣称的药理活性之间的关系尚不明确。鉴于需要为中成药产品的生物标准化确定合适的标志物,本研究旨在建立一种系统方法,以验证《中国药典》中列出的中药化学标志物是否可升级为对特定疾病具有一定治疗效果的生物活性标志物。我们提出的方法包括一系列关于提取、定量、文献检索和药理实验的工作,其中考虑了候选化学标志物的水提取性、理论剂量下的生物学效应和口服生物利用度。进一步阐述了这种生物活性标志物验证方法的可行性和意义。我们的研究结果将为中药生物标准化的进一步研发奠定基础。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/82b6/6544610/7c0024ac46e9/fx1.jpg

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