首页|60Co-γ射线辐照对利咽含漱液中木犀草苷含量的影响

60Co-γ射线辐照对利咽含漱液中木犀草苷含量的影响

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目的 探讨 60Co-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-C18 柱(250 mm×4。6 mm,5 μm),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 10 μL。分别以 6,10 kGy 60Co-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。895 4~47。385 8 μg/mL范围内与峰面积线性关系良好(r= 0。999 7,n= 6);检测限和定量限分别为 0。2ng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。890 1,16。269 3,12。743 4 μg/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 20 μg/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 60Co-γ射线辐照灭菌。
Effect of 60Co-γ-Ray Irradiation on the Content of Luteoloside in Liyan Gargle
Objective To investigate the effect of 60Co-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-C18 column(250 mm×4.6 mm,5 μm),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 10 μL.The samples were irradiated at 6,10 kGy of 60Co-γ-ray respectively,and the content of luteoloside was determined.Results The linear range of luteoloside was 1.895 4-47.385 8 μg/mL(r = 0.999 7,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 23.890 1 μg/mL(0 kGy,before irradiation),16.269 3 μg/mL(after irradiation at 6 kGy)and 12.743 4 μg/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 20 μg/mL.Conclusion The established method is easy,repeatable,specific and reliable,which can be used for quality evaluation of Liyan Gargle.60Co-γ-ray irradiation sterilization is not suitable for Liyan Gargle.

Liyan GargleluteolosideHPLCcontent determination60Co-γ rayirradiation

施崇精、李萍、王隽、蒲秋易、李瑞、肖佳佳

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四川省成都市中西医结合医院,四川 成都 610095

利咽含漱液 木犀草苷 高效液相色谱法 含量测定 60Co-γ射线 辐照

四川省中医药管理局科学技术研究专项课题

2021MS459

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(2)
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