一测多评法在五子衍宗丸质量控制中应用
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摘要
目的建立五子衍宗丸(WYP)一测多评的测定方法,并验证该方法在WYP质量控制中的适用性与准确性。方法以WYP为研究对象,以五味子醇甲为内参物,建立金丝桃苷、槲皮苷、山柰酚-3-O-芸香糖苷、五味子甲素、五味子乙素与其之间的相对校正因子(f_(s/k)),用fs/k计算各代表性成分量,实现一测多评;同时对一测多评的计算值与外标法实测值进行比较。结果在各自线性范围内,五味子醇甲与金丝桃苷、槲皮苷、山柰酚-3-O-芸香糖苷、五味子甲素、五味子乙素之间的f_(s/k)分别为0.36、4.86、0.88、7.34、6.35;且在不同色谱仪和不同色谱柱下有较好的重复性;利用一测多评法在不同色谱柱中的计算值与外标实测值之间没有显著性差异。结论一测多评法可同时对WYP中上述6种成分进行定量测定,该方法简便、准确、可靠,可有效控制WYP的质量。
Objective To establish a quantitative analysis of multi-component with a single-marker(QAMS) method for the quality control of Wuzi Yanzong Pills(WYP). Methods Six main effective components(schisandrin, hyperin, quercitrin, kaempferol 3-O-rutinoside, deoxyschizandrin, and γ-schizandrin) of WYP were simultaneously separated on a reversed-phase column(Ultimate LP-C18) with high-resolution of each chromatographic peak by high performance liquid chromatography(HPLC). Schisandrin was selected as the internal reference, and the relative correlation factors(RCFs) of other five components were calculated to achieve QAMS. The ruggedness of RCFs was tested on different instruments and columns. Moreover, results of the QAMS were compared with the external standard method. Results Within a certain linear range, the RCFs of hyperin, quercitrin, kaempferol 3-rutinoside, deoxyschizandrin, and γ-schizandrin were 0.36, 4.86, 0.88, 7.34, and 6.35, respectively. The repeatability was good under different experimental conditions. There were no significant differences between the calculated value and estimated value on QAMS and external standard method. Conclusion The QAMS method can be used to assay the content of six components of WYP simultaneously and control the quality of WYP simplely, reliably, and accurately.
Objective To establish a quantitative analysis of multi-component with a single-marker(QAMS) method for the quality control of Wuzi Yanzong Pills(WYP). Methods Six main effective components(schisandrin, hyperin, quercitrin, kaempferol 3-O-rutinoside, deoxyschizandrin, and γ-schizandrin) of WYP were simultaneously separated on a reversed-phase column(Ultimate LP-C18) with high-resolution of each chromatographic peak by high performance liquid chromatography(HPLC). Schisandrin was selected as the internal reference, and the relative correlation factors(RCFs) of other five components were calculated to achieve QAMS. The ruggedness of RCFs was tested on different instruments and columns. Moreover, results of the QAMS were compared with the external standard method. Results Within a certain linear range, the RCFs of hyperin, quercitrin, kaempferol 3-rutinoside, deoxyschizandrin, and γ-schizandrin were 0.36, 4.86, 0.88, 7.34, and 6.35, respectively. The repeatability was good under different experimental conditions. There were no significant differences between the calculated value and estimated value on QAMS and external standard method. Conclusion The QAMS method can be used to assay the content of six components of WYP simultaneously and control the quality of WYP simplely, reliably, and accurately.
引文
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[3]刘延泽,许利嘉,肖伟,等.中医药抗艾滋病优势的科学分析与前景展望[J].中草药,2012,43(9):1672-1684.
[4]Du G,Yun C,Wu J,et al.Effect of traditional Chinese medicine on oligoasthenospermatism:A narrative review[J].J Tradit Chin Med,2014,34(5):616-620.
[5]汪慧琪,魏林,吴伟,等.中医药治疗慢性肾功能衰竭的系统评价再评价[J].中草药,2014,45(5):738-744.
[6]桂元,薛承斌,詹继东,等.HPLC法测定参苓健体粉中去氢土莫酸、去氢茯苓酸、茯苓酸、白术内酯III和白术内酯I[J].现代药物与临床,2016,31(9):1331-1334.
[7]付娟,张海弢,王伟,等.芪白平肺颗粒HPLC指纹图谱研究及其多指标成分定量分析[J].中草药,2017,48(5):918-923.
[8]Cui H R,Xu G H,Jiang W Y,et al.Simultaneous determination of eight active components in Liuwei Wuling Tablet using HPLC[J].Chin Herb Med,2016,8(4):331-336.
[9]徐磊,杨宁,关健,等.人参根三醇组皂苷元25-OH-PPT、25-OCH3-PPT、PPT、PT的HPLC/ELSD法测定及其α-葡萄糖苷酶抑制活性研究[J].药物评价研究,2016,39(5):793-796.
[10]陆兔林,石上梅,蔡宝昌,等.基于一测多评的中药多成分定量研究进展[J].中草药,2012,43(12):2525-2529.
[11]段金芳,肖洋,刘影,等.一测多评法与电子眼和电子舌技术相结合优化山茱萸蒸制时间[J].中草药,2017,48(6):1108-1116.
[12]吕晓霞,陈宗良,陈桂茜,等.一测多评法在仙灵骨葆胶囊中多成分检测的应用研究[J].中草药,2016,47(24):4374-4378.
[13]董秋菊,王鑫国,牛丽颖,等.五子衍宗方制剂-药材谱峰匹配指纹图谱研究[J].中草药,2017,48(6):1153-1158.
[14]李敏芳,李慧,王学美.金丝桃苷药理作用研究进展[J].中国中医药信息杂志,2008,15(4):102-104.
[15]毛晓明.槲皮素对糖尿病大鼠肾脏的保护作用[J].江苏医药,1999,25(9):670-671.
[16]Yin J,Heo J H,Hwang Y J,et al.Inhibitory activities of phenolic compounds isolated from Adina rubella leaves against 5α-reductase associated with benign prostatic hypertrophy[J].Molecules,2016,21(7):887-898.
[17]王燕,杨旻,熊永兴,等.五味子甲素对铅染毒大鼠睾丸谷胱甘肽等生化指标的影响[J].中医药导报,2014,20(11):90-92.
[18]黄丽.五味子乙素的药理研究进展[J].甘肃医药,2008,27(6):8-9.
[19]王智民,钱忠直,张启伟,等.一测多评法建立的技术指南[J].中国中药杂志,2011,36(6):656-658.
[20]董宇,陈新.一测多评法在舒肝健脾丸质量控制中的应用[J].中国实验方剂学杂志,2014,20(4):70-73.