厚朴花(厚朴)配方颗粒指纹图谱及含量测定研究  

Fingerprint and Content Determination of Houpohua(Houpo) Formula Granules

作　　者：许豪杰 赵淑淑 俞杰 黄琪 俞思阳 XU Haojie;ZHAO Shushu;YU Jie;HUANG Qi;YU Siyang(Zhejiang Jolly Pharmaceutical Co.,Ltd.,Huzhou,Zhejiang,China 313200)

机构地区：[1]浙江佐力药业股份有限公司,浙江湖州313200

出　　处：《中国药业》2023年第19期86-90,共5页China Pharmaceuticals

基　　金：浙江省中医药管理局中药配方颗粒科研专项[浙中医药[2017]11号]。

摘　　要：目的 建立厚朴花(厚朴)配方颗粒的高效液相色谱(HPLC)指纹图谱及测定指标成分厚朴酚及和厚朴酚含量的HPLC法。方法 色谱柱为Welch Ultimate XB C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-乙腈-0.2%磷酸水溶液(50∶20∶30,V/V/V,含量测定)和乙腈-0.5%醋酸水溶液(梯度洗脱,指纹图谱),流速为1.0 mL/min,检测波长为294 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)进行相似度评价,建立16批厚朴花(厚朴)标准汤剂的HPLC指纹图谱,确定共有峰并验证。结果 厚朴酚、和厚朴酚质量浓度分别在1.756~43.90μg/mL、2.43~60.846 1μg/mL范围内与峰面积线性关系良好(R2=1.000 0,n=5);精密度、稳定性、重复性试验的RSD均小于2.00%;厚朴酚、和厚朴酚总量的平均加样回收率为98.53%,RSD为0.78%(n=6)。16批标准汤剂中均呈现4个共有峰,分别为峰1、峰2、峰3(和厚朴酚)、峰4(厚朴酚);相似度均不小于0.900。4批配方颗粒的指纹图谱与标准汤剂基本一致,相似度均大于0.900。结论 所建立的方法操作简便、结果准确、重复性好,结合所建立的指纹图谱可为厚朴花(厚朴)配方颗粒的质量评价提供参考。Objective To establish a high-performance liquid chromatography(HPLC) fingerprint of Houpohua(Houpo) Formula Granules,and to establish an HPLC method for the content determination of the indicator components(magnolol and honokiol).Methods The chromatographic column was Welch Ultimate XB C18column(250 mm × 4.6 mm,5 μm),the mobile phases were methanol-acetonitrile-0.2% phosphoric acid aqueous solution(50∶20∶30,V/V/V,content determination) and acetonitrile-0.5%acetic acid solution(gradient elution,fingerprints),the flow rate was 1.0 mL/min,the detection wavelength was 294 nm,the column temperature was 30 ℃,and the injection volume was 10 μL.The Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine(Version 2012) was used to evaluate the similarity,to establish HPLC fingerprints of16 batches of Houpohua(Houpo) standard decoction,and to identify and verify common peaks.Results The linear ranges of magnolol and honokiol were 1.756-43.90 μg/mL and 2.43-60.846 1 μg/mL(R~2= 1.000 0,n = 5),respectively.The RSDs of the precision,stability and repeatability tests were lower than 2.00%,and the average recovery of magnolol and honokiol was 98.53%with an RSD of 0.78%(n = 6).In the 16 batches of standard decoction,there were four common peaks,namely peak 1,peak 2,peak 3(honokiol),and peak 4(magnolol).The similarity was not lower than 0.900.The fingerprint of the four batches of formula granules was basically consistent with that of the standard decoction,and the similarity was higher than 0.900.Conclusion The established method is simple,accurate,and reproducible,which can provide a reference for the quality evaluation of Houpohua(Houpo) Formula Granules based on the established fingerprint.

关 键 词：厚朴花(厚朴)配方颗粒 厚朴酚 和厚朴酚 高效液相色谱法 指纹图谱 

分 类 号：R932[医药卫生—生药学] R284.1[医药卫生—药学] R286.0