摘要
采用HPLC-DAD-ELSD法,在最优波长(255nm)下同时测定了清开灵注射液的10种有效成分,测定了不同厂家的15个批次清开灵注射液样品,进行了质量相关性分析。所建立的分析方法符合规定标准,所测样品中,不同厂家及同厂家不同批次样品间各组分的含量差异悬殊(RSD值范围为2.17%～65.54%)。方法简便可靠,可用于清开灵注射液的质量控制。尽量多地控制这些已知的主要有效成分是保证清开灵注射液质量的关键。
A method was established for simultaneous determination of ten active components in Qingkailing injection （QKL）,and could be used as a feasible method for the quality control of QKL. HPLC-DAD-ELSD was employed for the determination at the optimal wavelength （255 nm）. Fifteen samples of QKL at different batches from different factories were analyzed by the means. The results show that the method is corresponding with specified standard. The contents from different samples （QKL from different factories and different batches） have great disparity （The RSD values range from 2.17% to 65.54%）. It is concluded that the method is reliable and convenient for the quality control of QKL. The key point of QKL quality control is to control the chief activity components as much as possible.
出处
《光谱学与光谱分析》
SCIE
EI
CAS
CSCD
北大核心
2009年第11期3112-3116,共5页
Spectroscopy and Spectral Analysis
基金
国家杰出青年科学基金项目(30625042)
国家中医药管理局研究专项(06-07ZP58)
国家自然科学基金项目(30701109)资助
