Comprehensive Quantitative Analysis of SQ Injection Using Multiple Chromatographic Technologies.
Comprehensive Quantitative Analysis of SQ Injection Using Multiple Chromatographic Technologies.
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DOI：
10.3390/molecules21081092
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发表时间：
2016-08-19
期刊：
影响因子：
--
通讯作者：
Han QB
中科院分区：
文献类型：
--
作者：
Chau SL;Huang ZB;Song YG;Yue RQ;Ho A;Lin CZ;Huang WH;Han QB
中药注射剂的质量控制仍然是一个挑战，由于我们的知识，其复杂的化学特征。本研究旨在通过全组分定量分析法对畅销注射剂之一参芪扶正注射液（SQI）的化学成分进行研究。采用超高效液相色谱-四极杆串联飞行时间质谱联用技术（UHPLC-Q-TOF-MS）同时测定了SQI中15种具有代表性的小分子组分;采用高效液相色谱-氨基柱蒸发光散射检测器（ELSD）对SQI酸水解前后的糖组分进行了定量分析。在凝胶渗透色谱柱上也检查了多糖的存在。该方法在线性、灵敏度、精密度、准确度和稳定性方面得到了良好的验证，并成功地应用于13个SQI样品的分析。结果表明，该注射液产品的定量含量高达94.69%（w/w），其中小分子和单糖/蔗糖分别占0.18%-0.21%和53.49%-58.2%。这些定量信息有助于为更好地了解复方中药注射剂的疗效和安全性积累科学证据。
Quality control of Chinese medicine injections remains a challenge due to our poor knowledge of their complex chemical profile. This study aims to investigate the chemical composition of one of the best-selling injections, Shenqi Fuzheng (SQ) injection (SQI), via a full component quantitative analysis. A total of 15 representative small molecular components of SQI were simultaneously determined using ultra-high performance liquid chromatography (UHPLC) coupled with quadrupole tandem time-of-flight mass spectrometry (Q-TOF-MS); saccharide composition of SQI was also quantitatively determined by high performance liquid chromatography (HPLC) with evaporative light scattering detector (ELSD) on an amino column before and after acid hydrolysis. The existence of polysaccharides was also examined on a gel permeation chromatography column. The method was well validated in terms of linearity, sensitivity, precision, accuracy and stability, and was successfully applied to analyze 13 SQI samples. The results demonstrate that up to 94.69% (w/w) of this injection product are quantitatively determined, in which small molecules and monosaccharide/sucrose account for 0.18%–0.21%, and 53.49%–58.2%, respectively. The quantitative information contributes to accumulating scientific evidence to better understand the therapy efficacy and safety of complex Chinese medicine injections.
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