Qualitative and quantitative analysis of cinobufacini injection using rapid separation liquid chromatography coupled with quadrupole-time-of-flight mass spectrometry and HPLC-photodiode array detection, a feasible strategy for the quality control of Chinese medicine injections
Qualitative and quantitative analysis of cinobufacini injection using rapid separation liquid chromatography coupled with quadrupole-time-of-flight mass spectrometry and HPLC-photodiode array detection, a feasible strategy for the quality control of Chinese medicine injections
复制标题
DOI：
10.1002/jssc.201200762
复制
发表时间：
2013-02-01
影响因子：
3.1
通讯作者：
Bian, Baolin
中科院分区：
文献类型：
--
作者：
Zhao, Haiyu;Wu, Xu;Bian, Baolin
华蟾素注射液是由中华大蟾蜍皮肤制成的，在临床上已显示出对治疗肝炎和多种癌症有显着疗效。然而，作为一个不清楚的复杂化学体系，其质量控制标记的优化一直是一个长期的挑战。本研究有效地提出了一种集标志物筛选、测定和统计分析于一体的可行策略，特别是针对未明确的中药注射剂。首先，首次应用快速分离LC-四极杆-TOF-MS方法对华蟾素注射液中19种主要成分进行鉴定。此外，选择九种高含量活性化合物作为定量分析的质量控制标志物。采用HPLC-光电二极管阵列检测法建立了17批华蟾素注射液的线性回归关系(r(2),0.9996-1)、精密度(RSD,0.02-1.35%)、重复性(RSD,0.05-1.97%)、稳定性(RSD,0.1-3.85%)和回收率的可接受且有效的测定方法。 (95.88-104.89%)。每种分析物均在其最大紫外光谱波长下进行检测。最后根据定量结果，对华蟾素注射液的质量评价进行主成分分析。这一三步走策略为中药注射剂的质量控制提供了新的可行解决方案。
Cinobufacini injection, prepared from the skin of Bufo bufo gargarizans Cantor, has presented its significant effects on the treatment of hepatitis and various cancers in the clinic. However, as an unclear complex chemical system, the optimization of its quality control markers has been a long-term challenge. In present study, a feasible strategy integrated markers screening, determination, and statistical analysis was efficiently proposed, especially for the undefined Chinese medicine injections. First, rapid separation LC-quadrupole-TOF-MS method was applied in the identification of 19 major compounds in the cinobufacini injection for the first time. Further, nine high-level contents active compounds were selected as quality control markers for the quantification analysis. An acceptable and validated determination method was established in 17 batches of cinobufacini injection by HPLC-photodiode array detection method, including linear regression relationship (r(2), 0.9996-1), precisions (RSD, 0.02-1.35%), repeatability (RSD, 0.05-1.97%), stability (RSD, 0.1-3.85%), and recovery (95.88-104.89%). Each analyte was detected at its maximum ultraviolet spectra wavelength. Finally, based on the quantification results, principal component analysis was performed on the quality assessment of cinobufacini injections. This three-step strategy provides a newly feasible solution for the quality control of Chinese medicine injections.