Meng-Hua Jiang, Chao L I, Fa-Gen Zhu, Wei-Quan B U, E Sun, Xiao-Bin Jia, Liang Feng
Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine Nanjing 210028, China.
Jiangsu key laboratory of chinese medicine and characteristic preparations for paediatrics, Jumpcan Pharmaceutical Co., Ltd Taixing 225400, China.
Zhongguo Zhong Yao Za Zhi. 2020 Sep;45(18):4299-4306. doi: 10.19540/j.cnki.cjcmm.20200423.301.
On the basis of anti-inflammatory activity, combined with multiple indicators, the quality markers of Pudilan Xiaoyan Oral Liquid were screened and determined for quality control. Lipopolysaccharide(LPS) was used to induce normal human bronchial epithelial cell(NHBE) inflammation model. The anti-inflammatory effects of the main chemical components in Pudilan Xiaoyan Oral Liquid were examined one by one, and the pharmacodynamic basis for the overall anti-inflammatory efficacy of Pudilan Xiaoyan Oral Liquid was clarified to identify the quality markers of Pudilan Xiaoyan Oral Liquid and the contents of the quality markers were determined by high performance liquid chromatography(HPLC). The results showed that adenosine, epigoitrin, chlorogenic acid, caffeic acid, cichoric acid, corynoline, baicalin, wogonoside, wogonin and oroxylin A had a certain regulatory effect on inflammatory factor tumor necrosis factor(TNF-α), interleukin(IL-1β) and IL-6 at specific concentrations in a dose-dependent manner. Considering the factors such as the IC_(50) value of each monomer component and the comprehensiveness of the quality control components, we proposed to use adenosine, cichoric acid, corynoline, baicalin and wogonin as quality markers of Pudilan Xiaoyan Oral Liquid. The contents of the five components were determined by HPLC, and the results showed that they were relatively stable in three batches of Pudilan Xiaoyan Oral Liquid. In this study, the quality control components selected by the anti-inflammatory activity test have a clear material basis, covering all four active pharmaceutical ingredients, which can fully reflect the quality of Pudilan Xiaoyan Oral Liquid, and effectively improve the quality control standard of Pudilan Xiaoyan Oral Liquid.
基于抗炎活性，结合多项指标，筛选并确定了蒲地蓝消炎口服液的质量标志物，用于质量控制。采用脂多糖（LPS）诱导正常人支气管上皮细胞（NHBE）炎症模型，逐一考察蒲地蓝消炎口服液中主要化学成分的抗炎作用，阐明蒲地蓝消炎口服液整体抗炎药效的物质基础，从而确定蒲地蓝消炎口服液的质量标志物，并采用高效液相色谱法（HPLC）测定质量标志物的含量。结果表明，腺苷、表告依春、绿原酸、咖啡酸、菊苣酸、紫堇灵、黄芩苷、汉黄芩苷、汉黄芩素和木犀草素A在特定浓度下对炎症因子肿瘤坏死因子（TNF-α）、白细胞介素（IL-1β）和IL-6具有一定的调节作用，且呈剂量依赖性。综合各单体成分的半数抑制浓度（IC₅₀）值及质量控制成分的全面性等因素，提出以腺苷、菊苣酸、紫堇灵、黄芩苷和汉黄芩素作为蒲地蓝消炎口服液的质量标志物。采用HPLC法测定这5种成分的含量，结果显示其在三批蒲地蓝消炎口服液中相对稳定。本研究通过抗炎活性试验筛选出的质量控制成分具有明确的物质基础，涵盖了全部4种活性成分，能够充分反映蒲地蓝消炎口服液的质量，有效提高了蒲地蓝消炎口服液的质量控制标准。
