^(60)Co-γ射线辐照对利咽含漱液中木犀草苷含量的影响

Effect of ^(60)Co-γ-Ray Irradiation on the Content of Luteoloside in Liyan Gargle

目的探讨^(60)Co-γ射线辐照对利咽含漱液中木犀草苷含量的影响。方法采用高效液相色谱法,色谱柱为Agilent Zorbax Eclipse XDB-C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸水溶液(20∶80,V/V),流速为1.0 mL/min,检测波长为350 nm,柱温为30℃,进样量为10μL。分别以6,10 kGy^(60)Co-γ射线对照品进行辐照,测定其中木犀草苷的含量。结果木犀草苷质量浓度在1.8954~47.3858μg/m L范围内与峰面积线性关系良好(r=0.9997,n=6);检测限和定量限分别为0.2 ng和0.4 ng;精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均加样回收率为100.47%,RSD为2.60%(n=9);样品辐照前(0 kGy)、辐照后(6,10 kGy)木犀草苷平均含量分别为23.8901,16.2693,12.7434μg/mL,RSD分别为2.73%,0.50%,1.36%(n=3)。考虑批间差异、药材差异等的影响,制剂中木犀草苷的含量限度暂定为20μg/mL。结论所建立的方法操作简便,重复性好,专属性强,结果可靠,可用于利咽含漱液的质量评价。利咽含漱液不宜使用^(60)Co-γ射线辐照灭菌。

Objective To investigate the effect of ^(60)Co-γ-ray irradiation on the content of luteoloside in Liyan Gargle.Methods High-performance liquid chromatography(HPLC)method was adopted.The chromatographic column was Agilent Zorbax Eclipse XDB-C_(18) column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.1% phosphoric acid aqueous solution(20∶80,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 350 nm,the column temperature was 30℃,and the injection volume was 10μL.The samples were irradiated at 6,10 kGy of ^(60)Co-γ-ray respectively,and the content of luteoloside was determined.Results The linear range of luteoloside was 1.8954-47.3858μg/mL(r=0.9997,n=6).The limit of detection of luteoloside was 0.2 ng,and its limit of quantification was 0.4 ng.The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rate of luteoloside was 100.47%,with an RSD of 2.60%(n=9).The average content of luteoloside in the samples was 23.8901μg/mL(0 kGy,before irradiation),16.2693μg/mL(after irradiation at 6 kGy)and 12.7434μg/mL(after irradiation at 10 kGy),with the RSDs of 2.73%,0.50% and 1.36%(n=3)respectively.Based on the inter-batch and medicinal differences,the content limit of luteoloside in the preparation was tentatively 20μg/mL.Conclusion The established method is easy,repeatable,specific and reliable,which can be used for quality evaluation of Liyan Gargle.^(60)Co-γ-ray irradiation sterilization is not suitable for Liyan Gargle.