基于一测多评法对保喉片中8种成分的质量控制研究

目的 建立一测多评法同时测定保喉片中毛蕊异黄酮葡萄糖苷、芒柄花苷、芒柄花素、桃叶珊瑚苷、哈巴苷、哈巴俄苷、木蝴蝶苷B和木蝴蝶苷A含量。方法 采用HPLC，以哈巴苷为内参物，建立其与毛蕊异黄酮葡萄糖苷、芒柄花苷、芒柄花素、桃叶珊瑚苷、哈巴俄苷、木蝴蝶苷B、木蝴蝶苷A的相对校正因子，计算其含量。采用Agilent TC-C₁₈色谱柱（250 mm×4.6 mm，5 μm），柱温：30℃。流动相A：乙腈-甲醇（9︰1）；流动相B：0.2%磷酸溶液；梯度洗脱，流速1.0 mL·min^-1。毛蕊异黄酮葡萄糖苷、芒柄花苷和芒柄花素的检测波长为254 nm；桃叶珊瑚苷、哈巴苷和哈巴俄苷的检测波长为210 nm；木蝴蝶苷B和木蝴蝶苷A的检测波长为280 nm；进样量为10μL。结果 毛蕊异黄酮葡萄糖苷、芒柄花苷、芒柄花素、桃叶珊瑚苷、哈巴苷、哈巴俄苷、木蝴蝶苷B、木蝴蝶苷A的线性范围分别为0.61~15.25，0.54~13.50，1.26~31.50，0.79~19.75，3.38~84.50，1.07~26.75，7.78~194.50，4.89~122.25 mg·L^-1，r为0.999 3~0.999 8；平均回收率分别为98.02%，96.99%，97.91%，98.32%，99.30%，97.83%，100.06%和99.62%，RSD分别为0.79%~1.42%（n=9）；毛蕊异黄酮葡萄糖苷、芒柄花苷、芒柄花素、桃叶珊瑚苷、哈巴俄苷、木蝴蝶苷B、木蝴蝶苷A的相对校正因子分别为1.051 6，1.209 9，0.721 7，0.875 0，0.899 7，1.127 0和0.760 4，待测成分含量一测多评法计算值和外标法实测值之间无明显差异。结论 该方法简单，准确，可以用于保喉片的质量评价研究。

Study on Quality Control of Eight Components in Baohou Tablets Based on Quantitative Analysis of Multi-components by Single Marker

OBJECTIVE To develop a quantitative analysis of multi-components by single marker(QAMS) method for simultaneous determination of the content of calycosin7-O-β-D-glucopyranoside, ononin, formononetin, aucubin, harpagide, harpagoside, oroxin B and oroxin A in Baohou tablets. METHODS Using HPLC with harpagide as an internal reference substance, its relative correction factor with calycosin7-O-β-D-Glucopyranoside, ononin, formononetin, aucubin, harpagoside, oroxin B and oroxin A was established and its content was calculated. The Agilent TC-C₁₈ column (250 mm×4.6 mm, 5 μm) was adopted, the column temperature was set at 30℃. The mobile phase was acetonitrile-methanol (9︰1)(A) and 0.2% phosphoric acid solution(B) with gradient elution, the flow rate was 1.0 mL·min^-1. The detection wavelength were set at 254 nm for calycosin7-O-β-D-glucopyranoside, ononin and formononetin, 210 nm for aucubin, harpagide and harpagoside, 280 nm for oroxin B and oroxin A. The injection volume was 10 μL. RESULTS The linear range of calycosin7-O-β-D-glucopyranoside, ononin, formononetin, aucubin, harpagide, harpagoside, oroxin B and oroxin A were 0.61-15.25, 0.54-13.50, 1.26-31.50, 0.79-19.75, 3.38-84.50, 1.07-26.75, 7.78-194.50, 4.89-122.25 mg·L^-1(r=0.999 3-0.999 8) respectively. The average recovery were 98.02%, 96.99%, 97.91%, 98.32%, 99.30%, 97.83%, 100.06% and 99.62%(RSD=0.79%-1.42%, n=9), respectively. RCFs of calycosin7-O-β-D-glucopyranoside, ononin, formononetin, aucubin, harpagoside, oroxin B and oroxin A were 1.051 6, 1.209 9, 0.721 7, 0.875 0, 0.899 7, 1.127 0 and 0.760 4, respectively. There were no significant differences between the calculated values by QAMS and the measured values by external standard method. CONCLUSION The method is simple and accurate, and can be used for quality evaluation of Baohou tablets.