Liang-Mian Chen, Hui-Min Gao, Xiao-Qian Liu, Wei-Hong Feng, Zhi-Min Wang, Yong-Xin Zhang, Chen-Xiao-Ning Meng, Yan-Hui Kuang, De-Qin Wang, Xin-Tong F U, Jing Nie
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 Beijing 100700, China.
Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Co., Ltd. Guangzhou 510515, China.
Zhongguo Zhong Yao Za Zhi. 2020 Sep;45(17):4221-4229. doi: 10.19540/j.cnki.cjcmm.20200603.301.
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%.
针对《中国药典》（2015年版）中穿心莲及其饮片质量标准存在的问题与局限性，对其质量标准进行改进与完善，并提出《中国药典》（2020年版）穿心莲及其饮片质量标准修订建议。采用硅胶G薄层板，以三氯甲烷 - 甲苯 - 甲醇（8∶1∶1）为展开剂，10%硫酸乙醇溶液为显色剂，建立了以穿心莲内酯及对照药材为对照的薄层色谱（TLC）鉴别方法。该方法重复性好、专属性强、灵敏度高。与《中国药典》2015年版原方法相比，展开效果更好，斑点清晰。在前期研究基础上，建立了以穿心莲内酯为内参物的一测多评（QAMS）法，同时测定4种二萜内酯类成分：穿心莲内酯（S）、新穿心莲内酯（A）、14 - 去氧穿心莲内酯（B）、脱水穿心莲内酯（C）的含量。测定得到f_(A/S)、f_(B/S)、f_(C/S)的相对校正因子分别为1.12、0.79、0.63；t_(A/S)、t_(B/S)、t_(C/S)的相对保留时间分别为1.95、2.18、2.25。根据46批药材和38批饮片的含量测定结果，规定药材和饮片中4种二萜内酯类成分总量分别不得少于1.5%和1.2%。与《中国药典》2015年版原方法相比，本QAMS法不仅能降低检测成本、提高效率，还能更全面、客观地评价穿心莲及其饮片的质量。二萜内酯类成分普遍被认为是穿心莲中的有效成分，其在叶中的含量远高于茎。然而，目前市售的穿心莲饮片几乎均以茎为原料加工而成，质量普遍较差，疗效难以保证。因此，应在穿心莲饮片检查项中增加叶的重量百分比，且不得少于25%。
