生脉注射液化学物质基础研究--大类成分的定量分析

Study on Chemical Substantial Basis of Shengmai Injection:Quantitative Analysis on Classes of Components

目的首次对生脉注射液所含大类化学成分进行全面、系统的定量分析。方法采用冷冻干燥法测定总固体。样品经大孔树脂柱分离得到不同组分,分别在626,538,254 nm下采用紫外-可见分光光度法测定总糖、总皂苷、总木脂素含量。样品经阳离子交换树脂纯化,采用电位滴定法测定总酸含量。采用炽灼残渣法测定总无机成分。结果3个厂家7批生脉注射中总固体、总糖、总皂苷、总木脂素、总酸、总无机成分含量分别在37.7~78.1,25.87~56.90,1.33~1.97,0.07~0.24,1.71~9.11,1.62~8.62 mg/ml之间,各大类成分总量占总固体80%以上。结论所建方法快速、简便、准确,一定程度上明确了生脉注射液的物质组成和相对比例,为后续单个成分的含量测定研究提供了实验基础。

Objective To conduct a comprehensive and systematic quantitative analysis on the majon categories chemical of components in Shengmai Injection for the first time.Methods Total solids were determined by freeze drying.The sample was separated by a macroporous resin column and different factions were determined by UV-vis spectrophotometry for total sugars,total saponins and total lignins at wavelengths of 626,538 and 254 nm,respectively.After the purification with a cation exchange resin column,total organic acids were determined by potentiometric titration.Finally,total inorganic components were determined as residues on ignition.Results The contents of total solids,total sugars,total saponins,total lignins,total organic acids and total inorganic components in 7 batches of Shengmai Injection from 3 manufacturers were 38.2-78.1,25.87-56.90,1.33-1.97,0.07-0.24,1.71-9.11,1.62-8.62 mg/ml,respectively.The percentages of contents of all classes of components in total solids were all above 80%.Conclusion The proposed method is rapid,simple and accurate.The material compositions and percentages of Shengmai Injection are clarified to a large extent,laying a foundation for the further assay of single chemical component.