六味能消制剂中土木香内酯和异土木香内酯含量测定研究及工艺探讨  

Study on the Determination and Technology of Alantolactone and Isoalantolactone in Liuwei Nengxiao Preparation

作　　者：焦兴苹 马青青 杨凤梅 JIAO Xingping;MA Qingqing;YANG Fengmei(Qinghai Provincial Drug Inspection and Testing Institute/Key Laboratory of Quality Control of Traditional Chinese,Xining 810016,China;Key Laboratory Quality Control/Qinghai Key Laboratory of Modernization Research of Chinese and Tibetan Medicine,Xining 810016,China)

机构地区：[1]青海省药品检验检测院/国家药品监督管理局中药(藏药),青海西宁810016 [2]质量控制重点实验室/青海省中藏药现代化研究重点实验室,青海西宁810016

出　　处：《中国民族民间医药》2022年第23期36-40,共5页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：青海省中藏药现代化研究重点实验室(2022-ZJ-Y22)。

摘　　要：目的:建立藏药六味能消丸(胶囊、片)中土木香内酯与异土木香内酯总含量的测定方法,并探讨该制剂生产工艺中温度对其影响。方法:采用气相色谱法。色谱柱:Agilent HP-5毛细管柱;检测器(FID)温度:280℃;分流比:5∶1;程序升温,流量:1.5 mL·min^(-1)。进样量:1μL。结果:土木香内酯、异土木香内酯分别在4.31~25.83μg·mL^(-1)(r=0.9981)、4.14~24.83 mg·mL^(-1)(r=0.9991)内线性关系良好;回收率分别为101.72%、102.85%(n=6);回收率、精密度、稳定性、重复性RSD均小于2.0%(n=6)。结论:该研究所建立的方法结果准确、重现性好,可有效测定六味能消丸(胶囊、片)的土木香内酯和异土木香内酯总含量;测定结果可有效反映生产工艺中温度对其含量的影响。Objective To establish a method for the determination of the total contents of alantolactone and isoalantolactone in Tibetan medicine Liuwei Nengxiao pills(capsules 、tablets),and to explore the effect of temperature in the production process of the preparation.Methods Gas chromatography.Chromatographic column: Agilent HP-5 capillary column;detector(FID) temperature: 280 ℃,split ratio: 5∶1;temperature programmed, flow rate: 1.5 mL·min^(-1);injection volume: 1 μL.Results The contents of alantolactone and isoalantolactone were 4.31~25.83 respectively μG·mL^(-1)(r=0.9981) and 4.14 ~ 24.83 mg·mL^(-1)(r=0.9991) showed good internal linearity;The recoveries were 101.72% and 102.85%(n=6);The RSD of recovery, precision, stability and repeatability RSD were less than 2.0%(n=6).Conclusion The method established in this study has accurate results and good reproducibility, and can effectively determine the total contents of alantolactone and isoalantolactone in Liuwei Nengxiao pills(capsules 、tablets);The determination results can effectively reflect the influence of temperature on its content in the production process.

关 键 词：六味能消制剂 气相色谱法 土木香内酯 异土木香内酯 生产工艺 

分 类 号：R29[医药卫生—民族医学]