不同辐照方法对苦参及制剂中生物碱类成分的影响

Effects of two irradiation methods on alkaloids in Sophorae Flavescentis Radix and its preparations

目的考察电子束辐照和^(60)Co辐照对苦参药材、苦参中间体提取物及痢泻灵片中4种苦参碱类成分含量的影响。方法用电子束辐照和^(60)Co辐照2种辐照方法,分别以0、1.5、3、5、7、10、20、30、40 kGy剂量对苦参、苦参中间体提取物及痢泻灵片进行辐照,采用HPLC法测定其氧化苦参碱、氧化槐果碱、苦参碱、槐果碱含量,并比较辐照前后成分含量变化。结果氧化苦参碱、氧化槐果碱、苦参碱、槐果碱分别在0.0469~0.9374μg、0.0205~0.4104μg、0.0989~1.9779μg、0.0487~0.9731μg范围内线性关系良好,平均回收率分别为98.1%、100.1%、100.5%、96.6%,RSD分别为1.69%、2.03%、3.14%、1.10%。电子束辐照和^(60)Co辐照2种辐照方法对苦参药材中氧化苦参碱、氧化槐果碱、苦参碱、槐果碱含量基本无影响,对苦参中间体提取物和痢泻灵片4个成分含量有影响。结论所建立的苦参碱类成分测定方法准确、重复性好、简单实用,可作为痢泻灵片质控方法。辐照对苦参药材苦参碱类成分含量影响不显著,高剂量辐照对苦参中间体及成药有影响,可为企业质量控制及灭菌辐照提供依据。

Objective To study the effects of electron beam irradiation and^(60)Co irradiation on the composition changes of four alkaloids in Sophorae Flavescentis Radix,intermediate extracts of Sophorae Flavescentis Radix and Lixieling Tablets.Methods Sophorae Flavescentis Radix,intermediate extracts of Sophorae Flavescentis Radix and Lixieling Tablets were irradiated at different doses of 0,1.5,3,5,7,10,20,30,40 kGy by electron beam irradiation and^(60)Co irradiation.The contents of oxymatrine,oxysophocarpine,matrine and sophocarpine were determined by HPLC,and the changes of the components before and after irradiation were compared.Results Oxymatrine,oxysophocarpine,matrine and sophocarpine were among 0.0469-0.9374μg,0.0205-0.4104μg,0.0989-1.9779μg,0.0487-0.9731μg,respectively.The linear relationship was good.The average recovery rates were 98.1%,100.1%,100.5%,96.6%,respectively,and the RSDs were 1.69%,2.03%,3.14%and 1.10%,respectively.Electron beam irradiation and^(60)Co irradiation had no statistical significance on the changes of oxymatrine,oxysophocarpine,matrine and sophocarpine in Sophora flavescens,but had statistical significance in the contents of intermediate extracts of Sophorae Flavescentis Radix and Lixieling Tablets.Conclusion The established method for the determination of matrine is accurate,reproducible,simple and practical,and can be used for the quality control of Lixieling Tablets.Irradiation has no significant effect on the content of Sophorae Flavescentis Radix,while high dose irradiation has significant effect on the intermediates and finished products of Sophorae Flavescentis Radix,which can provide a basis for quality control and sterilization irradiation of enterprises.