药学学报, 2021, 56(7): 1749-1756
引用本文:
孙昱, 徐敢, 马双成. 中药质量整体评价研究思路探讨[J]. 药学学报, 2021, 56(7): 1749-1756.
SUN Yu, XU Gan, MA Shuang-cheng. Development of an overall evaluation system for traditional Chinese medicine[J]. Acta Pharmaceutica Sinica, 2021, 56(7): 1749-1756.

中药质量整体评价研究思路探讨
孙昱1, 徐敢2*, 马双成3*
1. 国家药品监督管理局药品审评中心, 北京 100022;
2. 北京中医药大学, 北京 102248;
3. 中国食品药品检定研究院, 北京 100050
摘要:
本文通过学习领会中药生产全过程质量控制的内涵要求,综述现代科学技术和传统中医药研究方法,了解中药质量的基础研究现状,探讨建立和完善以临床为导向、符合临床实际和中医药特点的中药质量整体评价体系。本文探讨了以下问题:①中药质量的整体评价如何体现中药功效;②如何量化中药功效和中药药性;③如何理解中药功效和中药药性的关联性及其应用;④中药质量整体评价中,如何体现功效成分的专属性;⑤中药质量整体评价中,如何体现功效成分在生产全过程和体内代谢过程中的量值传递。中药整体质量评价需更好地体现临床相关的安全性和有效性。建议在关注中药化学成分含量的基础上,建立临床相关的质量评价方法,即探索建立体现中药功效的符合临床实际的中药质量整体评价方法。
关键词:    全过程质量控制      中药药性      功效      功效成分      量化评价     
Development of an overall evaluation system for traditional Chinese medicine
SUN Yu1, XU Gan2*, MA Shuang-cheng3*
1. Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China;
2. Beijing University of Chinese Medicine, Beijing 102248, China;
3. National Institutes for Food and Drug Control, Beijing 100050, China
Abstract:
This paper reviews modern science and technology with regard to traditional Chinese medicine (TCM) research methods, quality control, and discusses the establishment and improvement of the evaluation system for TCM, focusing on the following issues:1) How to incorporate the efficacy of TCM in the overall evaluation of TCM quality; 2) how to quantify the efficacy and properties of TCM; 3) how to understand the correlation between the efficacy and properties of TCM and its application; 4) how to reflect the specificity of the effective components in the overall evaluation of TCM quality; and 5) how to reflect the quality value transfer of effective components in the whole process of production and metabolism in vivo to the overall evaluation of TCM quality. The overall quality evaluation of TCM needs to better reflect its clinically safety and effectiveness. It is suggested to establish a clinical quality assessment method based on the content of the chemical components of TCM to explore and establish an overall evaluation method of TCM quality that reflects the efficacy of TCM and conforms with clinical practice.
Key words:    whole process quality control    property of traditional Chinese medicine    efficacy    effective component    quantitative evaluation   
收稿日期: 2021-03-03
DOI: 10.16438/j.0513-4870.2021-0307
基金项目: 国家科技重大专项资助项目(2018ZX09735-006);北京中医药大学中央高校基本科研业务费项目(2021-JYB-XJSJJ037).
通讯作者: 徐敢,E-mail:xgcg@163.com;马双成,Tel:86-10-53832076,E-mail:masc@nifdc.org.cn
Email: xgcg@163.com;masc@nifdc.org.cn
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参考文献:
[1] General Office of the State Council. General Office of the State Council issued a circular on policies and measures to accelerate the development of traditional Chinese medicine with distinctive features[EB/OL]. China:the State Council, 2021[2021-02-18]. http://www.gov.cn/zhengce/content/2021-02/09/content_5586278.htm.
[2] Implementation opinions of National Medical Products Administration on promoting the inheritance and innovation of traditional Chinese medicine[EB/OL]. Beijing:National Medical Products Administration, 2020[2021-02-18]. https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20201225163906151.html?type=pc&m=.
[3] Huang LQ. Considerations on the theoretical research of traditional Chinese medicine[J]. J Basic Chin Med (中国中医基础医学杂志), 2020, 26:2-4.
[4] Wei XC, Cao B, Luo CH, et al. Recent advances of novel technologies for quality consistency assessment of natural herbal medicines and preparations[J]. Chin Med, 2020, 15:56.
[5] Beć KB, Grabska J, Huck CW. NIR spectroscopy of natural medicines supported by novel instrumentation and methods for data analysis and interpretation[J]. J Pharm Biomed Anal, 2021, 193:113686.
[6] Wang MH, Jiang WY, Bian Y, et al. Rapid quality evaluation of Moutan Cortex by AOTF-NIR[J]. Chin J Pharm Anal (药物分析杂志), 2020, 40:382-387.
[7] Bian Y, Tong ZJ, Wei XY, et al. Rapid evaluation of the quality of Rhododendri Daurici Folium by AOTF-NIR[J]. Chin J Mod Appl Pharm (中国现代应用药学), 2020, 37:694-697.
[8] Li Y, Shen Y, Yao CL, et al. Quality assessment of herbal medicines based on chemical fingerprints combined with chemometrics approach:a review[J]. J Pharm Biomed Anal, 2020, 185:113215.
[9] Chen J, Yang L, Zhang Q, et al. Specific chromatograms of Glycyrrhiza uralensis Fisch. flavonoids in different growth years by HPLC coupled with chemometric analysis[J]. Chin Pharm J (中国药学杂志), 2020, 55:1415-1420.
[10] Chen J, Zhang Q, Zhao S, et al. Quality evaluation of Glycyrrhiza uralensis Fisch. in different harvest periods based on combinative methods of HPLC specific chromatogram, multi-component assay, and chemometrics[J]. Chin Pharm J (中国药学杂志), 2020, 55:1540-1547.
[11] Zhao XY, Liu R, Feng H, et al. Quality control of Platycodon grandiflorum based on chemometrics method and HPLC fingerprint[J]. Nat Prod Res Dev (天然产物研究与开发), 2020, 32:1491-1498.
[12] Tao XS, Gong HY, Xie CX, et al. Quality evaluation of Dioscorea zingiberensis C.H. Wright from different origins based on UPLC fingerprint and chemometrics[J]. Chin Tradit Herb Drugs (中草药), 2021, 52:227-233.
[13] Bai G, Liu CX, Zhang TJ, et al. Rapid evaluation of Chinese medicinal materials quality based on quality comprehensive evaluation index factor[J]. Chin Tradit Herb Drugs (中草药), 2021, 52:313-320.
[14] The Center for Drug Evaluation on the release of the "Chinese medicine biological effect detection research technical guidance (trial)"[EB/OL]. Beijing:Center for Drug Evaluation, National Medical Products Administration, 2020[2021-02-18]. http://www.cde.org.cn/news.do?method=viewInfoCommon&id=5f40f0e491c63db0.
[15] Chen EL, Li XX, Wu SN, et al. Study on quality evaluation of Angelica sinensis based on biological titer of activating blood[J]. J Chin Med Mater (中药材), 2019, 42:818-821.
[16] Liu J, Hao JJ, Liu SJ, et al. Biological evaluation for quality control of Asini Corii Colla based on macrophage phagocytosis model[J]. Mod Chin Med (中国现代中药), 2019, 21:771-781.
[17] Wang X, Gan QC, Shi JY, et al. Measurement of antiplatelet aggregation and potency of hirudo[J]. Acta Pharm Sin (药学学报), 2019, 54:2178-2183.
[18] Zhang DK, Zhao ZH, Li CY, et al. Quality evaluation of different processed products of Aconiti Lateralis Radix Praeparata combining bioassay and toxicity detection[J]. Acta Pharm Sin (药学学报), 2019, 54:2169-2177.
[19] Li SS, Zhang HZ, Zhang L, et al. Anti-inflammatory target prediction of Gentianae Radix et Rhizoma based on network pharmacology and construction of a bioassay method for its quality control[J]. China J Chin Mater Med (中国中药杂志), 2020. https://doi.org/10.19540/j.cnki.cjcmm.20201014.201.
[20] Liu X, Zhang H, Su M, et al. Comprehensive quality evaluation strategy based on non-targeted, targeted and bioactive analyses for traditional Chinese medicine:Tianmeng oral liquid as a case study[J]. J Chromatogr A, 2020, 1620:460988.
[21] Sun M, Wu H, He M, et al. Integrated assessment of medicinal rhubarb by combination of delayed luminescence and HPLC fingerprint with emphasized on bioactivities based quality control[J]. Chin Med, 2020, 15:72.
[22] Zhang TJ, Bai G, Liu CX. The concept, core theory and research methods of Chinese medicine quality markers[J]. Acta Pharm Sin (药学学报), 2019, 54:187-196.
[23] Zhang HJ, Gong SX, Xu J, et al. Research progress of Alismatis Rhizoma and prediction analysis on its Q-marker[J]. Chinese Tradit Herb Drugs (中草药), 2019, 50:4741-4751.
[24] Chen J, Hao EW, Feng X, et al. Chemical components and pharmacological action for Typhae Pollen with neutral property and predictive analysis on Q-marker[J]. Chin Tradit Herb Drugs (中草药), 2019, 50:4729-4740.
[25] Liu L, Zhang XM, Xu J, et al. Chemical components and pharmacological action for Euodiae Fructus and predictive analysis on its Q-marker[J]. Chin Tradit Herb Drugs (中草药), 2020, 51:2689-2702.
[26] Yao Y, Xu J, Huang GX, et al. Research progress of Moslae Herba and predictive analysis on its Q-marker[J]. Chin Tradit Herb Drugs (中草药), 2020, 51:2661-2670.
[27] Huang GX, Gong SX, Xu J, et al. Research progress of Cimicifugae Rhizoma and prediction analysis on Q-marker[J]. Chin Tradit Herb Drugs (中草药), 2020, 51:2651-2660.
[28] Zhang J, Wang D, Zhang X, et al. Application of "spider-web" mode in discovery and identification of Q-markers from Xuefu Zhuyu capsule[J]. Phytomedicine, 2020, 77:153273.
[29] Wu X, Liu Q, Chen D, et al. Identification of quality control markers in Suhuang antitussive capsule based on HPLC-PDA fingerprint and anti-inflammatory screening[J]. J Pharm Biomed Anal, 2020, 180:113053.
[30] Wang X, Chen X, Li J, et al. Thrombin-based discovery strategy of bioactive-chemical quality marker combination for pollen of Typha orientalis by metabolomics coupled with chemometrics[J]. Phytomedicine, 2020, 75:153246.
[31] Xiong H, Zhang AH, Zhao QQ, et al. Discovery of quality-marker ingredients of Panax quinquefolius driven by high-throughput chinmedomics approach[J]. Phytomedicine, 2020, 74:152928.
[32] Guo YY, Chang NW, Niu L, et al. Identification of anti-inflammatory substances in Zhachong Shisanwei pills and investigation of the underlying mechanisms[J]. Acta Pharm Sin (药学学报), 2020, 55:1265-1272.
[33] Yan ML, Ding GY, Cong LF, et al. Rapid evaluation of vasodilation efficacy of Angelica sinensis by near infrared spectroscopy based on quality markers[J]. Chin Tradit Herb Drugs (中草药), 2019, 50:4538-4546.
[34] Yan ML, Cong LF, Zhang ZY, et al. Rapid evaluation of anti-inflammatory efficacy of Angelica sinensis (Oliv.) Diels by near infrared spectroscopy based on quality markers[J]. J Instrum Anal (分析测试学报), 2020, 39:1320-1326.
[35] Tan P, Wang JB, Zhang DK, et al. Application of an effect-constituents index for the quality evaluation of the traditional Chinese medicine rhubarb[J]. Acta Pharm Sin (药学学报), 2019, 54:2141-2148.
[36] Liu TR, Jin Y, Meng HB, et al. Biological research of color and quality evaluation in "quality discrimination by character" of Chinese medicine[J]. China J Chin Mater Med (中国中药杂志), 2020, 45:4545-4554.
[37] Lim MY, Huang J, He FR, et al. Quality grade classification of China commercial moxa floss using electronic nose:a supervised learning approach[J]. Medicine (Baltimore), 2020, 99:e21556.
[38] Yu K, Liu W, Zhang N, et al. A novel method to identify three quality grades of herbal medicine Ophiopogonis Radix by microscopic quantification[J]. Front Pharmacol, 2021, 11:591310.
[39] Zhang TY, Guo CJ, Guo N, et al. Research progress on measurement of sensory indexes related to pharmacodynamics of traditional Chinese medicine[J]. Chin Tradit Herb Drugs (中草药), 2021, 52:594-602.
[40] Ren K, Fei Z, Wang Y, et al. Quality assessment of Typhae Pollen Carbonisata based on chromaticity analysis combined with UPLC fingerprinting and thrombin activity[J]. Phytochem Anal, 2020, 31:809-817.
[41] Deng L, Ding CS, Huang XD, et al. Quantitative study on medicinal properties of traditional Chinese medicine based on BP neural network[J]. Chin Tradit Herb Drugs (中草药), 2020, 51:4277-4283.
[42] Zhang J, Guo W, Li Q, et al. Discriminant analysis of traditional Chinese medicinal properties based on holistic chemical profiling by 1H-NMR spectrometry[J]. Evid Based Complement Alternat Med, 2020, 2020:3141340.
[43] Gu Q, Zhu XM, Wei XC, et al. Effect of hot or warm property on skin toxicity of essential oil as penetration enhancer and its mechanism[J]. China J Chin Mater Med (中国中药杂志), 2021, 46:359-365.
[44] Jiang WK, Zhou T, Huang LQ. A system of theories and methods for predicting the efficacy of traditional Chinese medicine:a case study of Aspidistra[J]. Mod Chin Med (中国现代中药), 2020, 22:1763-1783.
[45] Hou XJ, Zhao F, Wang CD, et al. Literature research of Passiflora incarnate and discussion of its Chinese medicine properties[J]. China J Chin Mater Med (中国中药杂志), 2020. https://doi.org/10.19540/j.cnki.cjcmm.20200915.401.
[46] Wang CD, Hou XJ, Zhao F, et al. Literature research and medicinal properties of Aspalathus linearis[J]. China J Chin Mater Med (中国中药杂志), 2020. https://doi.org/10.19540/j.cnki.cjcmm.20200915.410.
[47] Liu YL, Lei R, Wang XL, et al. Research on quality control methods of Panax ginseng, Panax quinquefolius, Panax notoginseng and related proprietary Chinese medicines based on Q-Marker[J]. Chin Pharm J (中国药学杂志), 2019, 54:1402-1410.
[48] Dai Y, Wang D, Zhao M, et al. Quality markers for Astragali Radix and its products based on process analysis[J]. Front Pharmacol, 2020, 11:554777.
[49] Zhang H, Wu X, Liu X, et al. Quality transitivity of Danhong Huayu Koufuye:a study on chemical profiles of medicinal herbs, compound preparation and dosed rat plasma using ultra-performance liquid chromatography-quadrupole time-of-flight mass spectrometry[J]. Biomed Chromatogr, 2020, 34:e4813.
[50] Duan S, Niu L, Yin T, et al. A novel strategy for screening bioavailable quality markers of traditional Chinese medicine by integrating intestinal absorption and network pharmacology:application to Wu Ji Bai Feng pill[J]. Phytomedicine, 2020, 76:153226.
[51] Zhang G, Wang Q, Liu X, et al. An integrated approach to uncover quality markers of traditional Chinese medicine underlying chemical profiling, network target selection and metabolomics approach:Guan-Xin-Jing capsule as a model[J]. J Pharm Biomed Anal, 2020, 190:113413.
[52] Duan JA, Guo S, Yan H, et al. Analysis of restrictive factors in establishing the mechanism of good price for high quality of Chinese medicinal materials and discussion on its implementation path[J]. Mod Chin Med (中国现代中药), 2019, 21:1283-1287.
[53] Qian XY, Nie LX, Dai Z, et al. Research progress on evaluation of quality grade of traditional Chinese medicine[J]. Chin J Pharm Anal (药物分析杂志), 2019, 39:1724-1737.
[54] Zhan ZL, Deng AP, Fang WT, et al. Principles, bases and methods for revising standards of commercial grades for Chinese materia medica[J]. Mod Chin Med (中国现代中药), 2019, 21:699-706.
[55] Zhang Y, Deng AP, Fang WT, et al. Standards of commercial grades for Chinese materia medica of fruits and seeds:taking six kinds of materia medica such as Lycii Fructus, Aurantii Fructus, Gardeniae Fructus, Platycladi Semen et al as examples[J]. Mod Chin Med (中国现代中药), 2019, 21:717-722.
[56] Zhan ZL, Deng AP, Xie DM, et al. Standards of commercial grades for Chinese materia medica of radix or rhizoma Chinese medicinal materials:taking six kinds of materia medica such as Astragali Radix, Salviae Miltiorrhizae Radix et Rhizoma et al as examples[J]. Mod Chin Med (中国现代中药), 2019, 21:707-716.
[57] Deng AP, Zhang Y, Fang WT, et al. Standards of commercial grades for Chinese materia medica of cortexes, flowers, leaves, stalks and herbas:taking seven kinds of materia medica such as Moutan Cortex, Eucommiae Cortex Lonicerae Japonicae Flos et al as examples[J]. Mod Chin Med (中国现代中药), 2019, 21:723-730.
[58] Zhang Y, Deng AP, Fang WT, et al. Standards of commercial grades for Chinese materia medica of animals, minerals, fungi and others:taking seven kinds of materia medica such as Cervi Cornu Pantotrichum, Hirudo, Ganoderma et al as examples[J]. Mod Chin Med (中国现代中药), 2019, 21:731-752.