“一测多评”法测定咳喘宁片中5种生物碱类成分的含量  

Simultaneous Assay of Five Kinds of Alkaloids in Kechuanning Tablets by Quantitative Analysis of Multi components by Single Marker

作　　者：刘永利 李冬梅 冯丽 牛小莲 

机构地区：[1]河北省食品药品检验院,石家庄050011

出　　处：《中药新药与临床药理》2012年第4期464-468,共5页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：河北省自然科学基金-石药集团医药联合研究基金(C2011320007)

摘　　要：目的建立咳喘宁片中5种生物碱类成分的一测多评含量测定方法。方法采用高效液相色谱法,色谱柱:Agilent XDB-C1(84.6 mm×150 mm,5μm),流动相为乙腈与0.1%磷酸溶液梯度洗脱,检测波长为210 nm(吗啡、磷酸可待因、盐酸麻黄碱和盐酸伪麻黄碱)与251 nm(盐酸罂粟碱),以吗啡为对照,建立吗啡与磷酸可待因、盐酸罂粟碱、盐酸麻黄碱、盐酸伪麻黄碱的校正因子,并利用该校正因子计算磷酸可待因、盐酸罂粟碱、盐酸麻黄碱、盐酸伪麻黄碱的含量,实现一测多评,同时利用外标法测定这4种成分的含量,比较两者的差异,验证一测多评法的准确性和科学性。结果采用校正因子计算的含量值与外标法实测值之间没有明显差异。结论用一测多评法对咳喘宁片进行质量控制是可行的、准确的。Objective To establish a method for simultaneous assay of 5 kinds of alkaloids in Kechuanning tablets by quantitative analysis of multi-components by single marker（QAMS）. Methods The chromatographic separation was performed on a Agilent XDB-C18 column（4.6 mm×150 mm,5 μm） with gradient elution using acetonitrile and 0.1% phosphoric acid as mobile phase. The detection wavelength was at 210 nm for morphine, codeine phosphate, ephedrine hydrochloride and pseudoephedrine hydrochloride, and was 251 nm for papaverine hydrochloride. The rela tire correction factors （RCF） of morphine to codeine phosphate, papaverine hydrochloride, ephedrine hydrochloride and pseudoephedrine hydrochloride were calculated by HPLC with different instruments and chromatographic columns. The method was evaluated by comparison of the quantitative results between external standard method and QAMS method. Results The results of QAMS method were not significantly different from those of external standard method. Conclusion It is feasible and accurate to control the quality of Kechuanning tablets with QAMS

关 键 词：一测多评法 校正因子 高效液相色谱法 咳喘宁片 

分 类 号：R284.1[医药卫生—中药学]