中国中药杂志

2020, v.45(17) 4221-4229

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关于《中国药典》2020年版穿心莲药材和饮片质量标准的修订建议
Recommendations on quality standards of Andrographis Herba and its processed slices in Chinese Pharmacopoeia (2020 edition)

陈两绵;高慧敏;刘晓谦;冯伟红;王智民;张永欣;孟辰笑凝;匡艳辉;王德勤;傅欣彤;聂晶;
CHEN Liang-mian;GAO Hui-min;LIU Xiao-qian;FENG Wei-hong;WANG Zhi-min;ZHANG Yong-xin;MENG Chen-xiao-ning;KUANG Yan-hui;WANG De-qin;FU Xin-tong;NIE Jing;National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicine, Key Laboratory of SATCM for Process Analysis Technology of Chinese Herbal Medicines, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences;Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Co., Ltd.;Beijing Key Laboratory of An

摘要(Abstract):

针对《中国药典》2015年版中穿心莲药材和饮片标准存在的问题和局限性,对其质量标准进行改进和完善,为《中国药典》2020年版穿心莲药材和饮片质量标准的修订提出建议。采用硅胶G薄层板,三氯甲烷-甲苯-甲醇(8∶1∶1)为展开剂,10%硫酸乙醇溶液为显色剂,建立以穿心莲内酯和穿心莲对照药材为对照的薄层鉴别方法。该法重现性好,专属性强,灵敏度高,与原标准的薄层鉴别项比较,该法展开效果好,斑点清晰。结合前期研究,建立以穿心莲内酯为内参物,同步测定穿心莲内酯(S)、新穿心莲内酯(A)、14-去氧穿心莲内酯(B)和脱水穿心莲内酯(C)等4种二萜内酯含量的一测多评法(QAMS),确定相对校正因子分别为f_(S/A)=1.12,f_(S/B)=0.79,f_(S/C)=0.63,相对保留时间分别为t_(A/S)=1.95,t_(B/S)=2.18,t_(C/S)=2.25。根据46批药材和38批饮片中4种二萜内酯的测定结果,规定药材中4种二萜内酯总量不得少于1.5%,饮片中4种二萜内酯总量不得少于1.2%。与原标准的含量测定项比较,QAMS不仅可以降低检测成本,提高工作效率,而且可以更加全面而又客观的评价穿心莲药材和饮片的质量。二萜内酯是穿心莲公认的有效成分且在叶中的含量远高于茎,然而,当前市售饮片几乎均为茎,质量普遍较差,难以保障药效。因此,在饮片的检查项中新增含叶量,并规定不得少于25%。
To improve and perfect the quality standards and propose recommendations for the revision of quality standards for Andrographis Herba and its processed slices in Chinese Pharmacopoeia(ChP)(2020 edition) based on the problems and limitations in ChP(2015 edition). TLC identification method with andrographolide and control herbs as references was established using silica gel G thin layer plate, with chloroform-methylbenzene-methanol(8∶1∶1) as developing solvent, and 10% sulfuric acid ethanol solution as colour-developing agent. This method has good reproducibility, strong specificity and high sensitivity. As compared with the original method in ChP 2015, this method has better development effect and clearer spots. Based on the previous research, a quantitative analysis of multi-components by single-marker(QAMS) method with andrographolide as the internal reference substance was developed to simultaneously determine the contents of 4 diterpene lactones: andrographolide(S), neoandrographolide(A), 14-deoxyandrographolide(B), and dehydroandrographolide(C). The relative correction factors of f_(A/S), f_(B/S), and f_(C/S) were determined as 1.12, 0.79, and 0.63, respectively. The relative retention time of t_(A/S), t_(B/S), and t_(C/S) was 1.95, 2.18, and 2.25, respectively. According to the content determination results in 46 batches of crude drugs and 38 batches of processed slices, it was stipulated that the total contents of 4 diterpene lactones should not be less than 1.5% and 1.2% in crude drugs and processed slices, respectively. As compared with the original method in ChP 2015, the present QAMS method could not only reduce the detection cost and improve the efficiency, but also can be used to evaluate the quality of Andrographis Herba and its processed slices more comprehensively and objectively. Diterpene lactones are generally recognized as the effective components in Andrographis Herba, and their contents in leaves were much higher than those in stems. However, almost all of the current commercial processed slices are processed from stems, so their quality is gene-rally poor and the efficacy is hard to be guaranteed. Therefore, the weight percentage of leaves should be added into the inspection items of the processed slices and it should not be less than 25%.

关键词(KeyWords): 穿心莲;质量标准;薄层鉴别;含量测定;一测多评
Andrographis Herba;quality standard;TLC identification;content determination;QAMS(quantitative analysis of multi-components by single-marker)

Abstract:

Keywords:

基金项目(Foundation): 国家“重大新药创制”科技重大专项(2018ZX09201-011);; 国家中药标准化项目(ZYBZH-Y-GD-12);; 国家药典委员会课题(2018Z005)

作者(Author): 陈两绵;高慧敏;刘晓谦;冯伟红;王智民;张永欣;孟辰笑凝;匡艳辉;王德勤;傅欣彤;聂晶;
CHEN Liang-mian;GAO Hui-min;LIU Xiao-qian;FENG Wei-hong;WANG Zhi-min;ZHANG Yong-xin;MENG Chen-xiao-ning;KUANG Yan-hui;WANG De-qin;FU Xin-tong;NIE Jing;National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicine, Key Laboratory of SATCM for Process Analysis Technology of Chinese Herbal Medicines, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences;Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Co., Ltd.;Beijing Key Laboratory of An

Email:

DOI: 10.19540/j.cnki.cjcmm.20200603.301

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