药学学报, 2019, 54(12): 2149-2154
引用本文:
张慧, 李思雨, 冯宏玲, 李穆睿, 裴志东, 康廷国. 基于效应成分指数的双黄连制剂质量控制研究[J]. 药学学报, 2019, 54(12): 2149-2154.
ZHANG Hui, LI Si-yu, FENG Hong-ling, LI Mu-rui, PEI Zhi-dong, KANG Ting-guo. Quality control of Shuanghuanglian preparations using an effect-constituent index[J]. Acta Pharmaceutica Sinica, 2019, 54(12): 2149-2154.

基于效应成分指数的双黄连制剂质量控制研究
张慧, 李思雨, 冯宏玲, 李穆睿, 裴志东, 康廷国
辽宁中医药大学药学院, 辽宁 大连 116600
摘要:
建立一种以临床功效为导向的,将功效作用与成分含量关联的,基于效应成分指数的双黄连制剂质量控制方法。采用HPLC法建立双黄连制剂的定量指纹图谱,分别测定不同来源批次双黄连制剂中黄芩苷、绿原酸、咖啡酸、木犀草苷、木犀草素、野黄芩苷、汉黄芩素、黄芩素、连翘苷、连翘酯苷A共10个指纹成分的含量;借鉴抗生素微生物检定法,以金葡菌为生物模型,检测不同来源双黄连制剂的抗菌效价;通过偏最小二乘-判别分析法(PLC-DA)进行"量-效"相关性分析,筛选出双黄连制剂的抗菌功效成分;根据各抗菌功效成分的抗菌效价和含量,结合自定义权重系数分配方法,计算抗菌效应成分指数并加以验证。结果,采用效应成分指数可以实现通过成分的含量评价双黄连制剂的抗菌功效作用,能够反映制剂的质量,为中药质量控制提供新的研究思路和方法。
关键词:    双黄连制剂      效应成分指数      抗菌效价      定量指纹图谱      质量控制     
Quality control of Shuanghuanglian preparations using an effect-constituent index
ZHANG Hui, LI Si-yu, FENG Hong-ling, LI Mu-rui, PEI Zhi-dong, KANG Ting-guo
College of Pharmacy, Liaoning University of Traditional Chinese Medicine, Dalian 116600, China
Abstract:
We established a quality evaluation method for Shuanghuanglian preparations based on an effect-constituent index (ECI), which is guided by the clinical efficacy of Shuanghuanglian and a dose-efficacy correlation. An HPLC method was used to establish the quantitative fingerprint of Shuanghuanglian from different manufacturers and to determine the content of 10 fingerprint components, including baicalin, chlorogenic acid, forsythin, galuteolin, wogonin, forsythoside A, luteolin, caffeic acid, baicalein, and scutellarin. Using Staphylococcus aureus as biological model, the potency of Shuanghuanglian preparations was determined by antibiotic microbial assay. Using the method of PLC-DA, the efficacious antibacterial components were screened by "dose-efficacy" correlation analysis. According to the antibacterial potency and content of the antibacterial ingredients, combined with the method of the custom weight coefficient, ECI was calculated and verified. The results show that the antibacterial ECI can facilitate evaluation of the efficacy of Shuanghuanglian based on the composition of its contents, providing a new method for the quality control of traditional Chinese medicine.
Key words:    Shuanghuanglian preparation    effect-constituent index    antibacterial potency    quantitative fingerprint chromatogram    quality control   
收稿日期: 2019-09-05
DOI: 10.16438/j.0513-4870.2019-0449
基金项目: 国家自然科学基金资助项目(81874338);辽宁省教育厅优秀人才(第一层次)基金资助项目(LR2015042).
通讯作者: 裴志东,E-mail:pzd87586078@163.com;康廷国,E-mail:kangtingguo@163.com
Email: pzd87586078@163.com;kangtingguo@163.com
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