基于指纹图谱、多指标含量测定的头痛宁胶囊质量评价

目的：建立指纹图谱、多指标定量相结合的头痛宁胶囊质量评价方法。方法：采用高效液相色谱法，选用Kromasil C₁₈色谱柱（250 mm×4.6 mm，5 μm）；以甲醇-0.1%磷酸水溶液为流动相，梯度洗脱；流速：1.0 mL·min^-1；柱温：30℃；检测波长：220 nm（0~40 min）、290 nm（40~100 min）；进样量：10 μL。运用"中药色谱指纹图谱相似度评价系统（2012版）"对15批样品色谱图进行分析，以落新妇苷为参照，确定22个共有峰为特征峰，相似度均>0.977；天麻素、阿魏酸、落新妇苷、5-O-甲基维斯阿米醇苷、二苯乙烯苷线性关系良好，r均>0.999 9，加样回收率在95.5%~98.9%，RSD<5%（n=6）。结论：该方法简便、准确及专属性强，可用于头痛宁胶囊质量控制和综合评价。

Quality evaluation of Tou Tongning capsule based on fingerprint and multi-index content determination

OBJECTIVE To establish a method for quality evaluation of Tou tongning capsule by combining fingerprint and quantitative analysis.METHODS High performance liquid chromatography (HPLC) was used with Kromasil column (250 mm×4.6 mm,5 μm).The conditions were as follows:methanol-0.1% phosphoric acid solution as mobile phase,gradient elution;Flow rate:1.0 mL·min^-1;Column temperature:30℃;Detection wavelength:220 nm (0~40 min),290 nm (40~100 min);Injection:10 μL.The chromatogram of 15 batches of samples was analyzed by the "similarity evaluation system of Chinese medicine chromatogram fingerprint (2012 edition) ",and 22 common peaks were determined as characteristic peaks with the reference of glucoside,with the similarity up 0.977.There was a good linear relationship between gastrodin,ferulic acid,astilbin,5-O-methylvisamidoside and stibene glucoside,r>0.999 9.The recoveries were between 95.5% and 98.9%,and RSD were under 5% (n=6).CONCLSION The method is simple,accurate and specific,and can be used for quality control and comprehensive evaluation of Tou tongning capsules.