小儿热速清口服液HPLC指纹图谱的建立及多指标成分的含量测定

Establishment of HPLC fingerprint and content determination of multiple index components in Xiao’er resuqing oral liquid

目的建立小儿热速清口服液高效液相色谱(HPLC)指纹图谱,并对其中12种指标成分进行含量测定。方法采用HPLC法。以Venusil MP C18为色谱柱;以乙腈-0.1%磷酸溶液为流动相进行梯度洗脱;流速为1.0 mL/min;检测波长为210 nm;柱温为30℃;进样量为10μL。采用《中药色谱指纹图谱相似度评价系统(2012版)》建立13批小儿热速清口服液的HPLC指纹图谱,并进行相似度评价,测定12种指标成分,即(R,S)告依春、3,5-二-O-咖啡酰奎宁酸、葛根素、连翘苷、连翘酯苷A、绿原酸、黄芩苷、柴胡皂苷d、汉黄芩苷、黄芩素、大黄素、大黄酚的含量。结果13批小儿热速清口服液指纹图谱的相似度均大于0.97,指认了14个共有峰。13批小儿热速清口服液中上述12种指标成分的含量分别为0.078~0.172、1.564~2.736、1.338~2.578、0.426~0.872、1.477~2.628、1.396~2.447、4.052~9.146、0.367~0.692、1.974~4.674、1.274~2.969、0.085~0.167、0.155~0.307 mg/mL。结论本研究建立的HPLC指纹图谱及含量测定方法准确度高、专属性好,可用于小儿热速清口服液的质量评价。

OBJECTIVE To establish an HPLC fingerprint of Xiao’er resuqing oral liquid,and to determine the contents of twelve index components.METHODS HPLC method was adopted.The determination was performed on Venusil MP C18 column with mobile phase consisting of acetonitrile-0.1% phosphate aqueous solution(gradient elution)at a flow rate of 1.0 mL/min.The detection wavelength was set at 210 nm,the column temperature was 30℃,the injection volume was 10μL.HPLC fingerprint of Xiao’er resuqing oral liquid was established by using the Similarity Evaluation System of Chromatographic Fingerprint of TCM(2012 edition)to evaluate the similarity.The contents of 12 components were determined,including(R,S)-goitrin,3,5-O-dicaffeoyl quinic acid,puerarin,forsythin,forsythoside A,chlorogenic acid,baicalin,saikosaponins d,wogonoside,baicalein,emodin and chrysophanol.RESULTS The similarity of HPLC fingerprints of 13 batches of Xiao’er resuqing oral liquid was greater than 0.97,and 14 common peaks were confirmed.The contents of the above 12 index components in 13 batches of Xiao’er resuqing oral liquid were as follows:0.078-0.172,1.564-2.736,1.338-2.578,0.426-0.872,1.477-2.628,1.396-2.447,4.052-9.146,0.367-0.692,1.974-4.674,1.274-2.969,0.085-0.167 and 0.155-0.307 mg/mL.CONCLUSIONS The established HPLC fingerprint and content determination methods have high accuracy and high specificity,which can be used for the quality evaluation of Xiao’er resuqing oral liquid.