铁皮石斛浸膏中有机溶剂残留的方法学研究

Report of Dendrobium officinale Extractum about Residual Organic Solvents

参照GB 24396—2009中有机溶剂残留的检测方法,通过顶空气相色谱法(HS-GC)完成铁皮石斛浸膏中有机溶剂残留的方法验证过程中的部分测试工作。结果表明,10种溶剂残留目标物均在180~1200 ng/mL的浓度区间内得到了良好的线性回归系数,且准确度、重复性、耐用性、检测限、定量限均符合2020年版《中国药典》中方法学验证的要求。并发现全浸膏工艺中的乙醇溶剂会对残留溶剂苯的检测产生干扰,宜使用质谱法检测,为后续全浸膏类中药产品的质控工作提供更为广阔的研究思路。

Article completes part of the test work in the method validation of the organic solvent residue in Dendrobium officinale extractum by Head Space Gas Chromatography(HS-GC),which refers to the method of GB 24396—2009.Experimental results show that 10 target substances have obtained excellent linear regression coefficients in the concentration range of 180~1200 ng/mL,and the accuracy,repeatability,durability,LOD,and LOQ in this report were all arrived demand of Chinese Pharmacopoeia in 2020 edition.Found in further research that the ethanol solvent in the extract process would interfere with the residual solvent benzene,response to this situation the author puts forward suggestions for improvement,At the same time it provide broader research ideas for the quality control of traditional Chinese medicine products.