生脉注射液中总糖、总皂苷和总木脂素的含量测定方法建立及应用  

Development and application of the determination methods for total sugars,total saponins and total lignans in Shengmai Injection

作　　者：刘瑞 聂黎行[2] 陈佳[2] 戴忠[2] 王钢力[2] 马双成[2] LIU Rui;NIE Li-xing;CHEN Jia;DAI Zhong;WANG Gang-li;MA Shuang-cheng(College of Chinese Medicine and Food Engineering,Shanxi University of Chinese Medicine,Jinzhong 030619,China;National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]山西中医药大学中药与食品工程学院,晋中030619 [2]中国食品药品检定研究院,北京100050

出　　处：《中国新药杂志》2022年第11期1112-1118,共7页Chinese Journal of New Drugs

基　　金：国家自然科学基金资助项目(81303194);山西中医药大学科技创新能力培育计划(2020PY-YC-09)。

摘　　要：目的:建立生脉注射液中总糖、总皂苷、总木脂素的含量测定方法并用于样品的测定,为进一步的物质基础、质量、药效研究提供实验依据。方法:采用紫外-可见分光光度法,样品经大孔树脂柱分离,水洗脱液经蒽酮-硫酸显色后在626 nm测定总糖含量;75%乙醇洗脱液经香草醛-硫酸显色后在538 nm测定总皂苷含量;乙醇洗脱液经乙酸乙酯萃取后在254 nm测定总木脂素含量。结果:3类成分在各自范围内线性关系良好,精密度、重复性、稳定性实验的相对标准偏差均低于3%,平均回收率分别为101.2%,101.8%,95.9%。3个厂家的7批次样品中总糖、总皂苷、总木脂素的含量分别在25.87~56.90,1.33~1.97,0.07~0.24 mg·mL^(-1)之间。结论:所建方法灵敏、准确、简便、快速,为中药注射剂中大类成分的分析提供了参考。Objective:To establish determination methods for total sugars,total saponins and total lignans in Shengmai Injection and apply them in sample determination,so as to offer experimental evidence for investigation on the material basis,quality and pharmacology of the drug.Methods:The ultraviolet spectrophotometry and colorimetry were applied.The samples were separated by a macroporous resin column.The water elute was reacted with anthrone-sulfuric acid and then determined at 626 nm for total sugars.The 75%ethanol elute was reacted with vanillin-sulfuric acid and then determined at 538 nm for total saponins.The ethanol elute were extracted by ethyl acetate and then determined at 254 nm for total lignans.Results:The calibration curves of the 3 analytes showed good linearity within their test ranges.Their relative standard deviations for precision,repeatability and stability were all below 3.0%.The average recoveries were 101.2%,101.8%and 95.9%,respectively.The contents of total sugars,total saponins and total lignans in 7 samples from 3 manufacturers were between 25.87~56.90,1.33~1.97 and 0.07~0.24 mg·mL^(-1),respectively.Conclusion:The proposed methods were sensitive,accurate,simple and fast,thus provide a reliable approach for the content analysis of class of components in TCM injection.

关 键 词：生脉注射液 总糖 总皂苷 总木脂素 含量测定 紫外-可见分光光度法 

分 类 号：R932[医药卫生—生药学] R927.1[医药卫生—药学]