四磨汤口服液的质量控制研究

Study on the Quality Control of Simotang Oral Liquid

目的:建立四磨汤口服液4种指标性成分(新橙皮苷、橙皮苷、柚皮苷、去甲异波尔定)含量测定方法及薄层鉴别方法,为四磨汤口服液的质量控制提供依据。方法:采用薄层色谱(TLC)定性鉴别四磨汤口服液中的枳壳、木香和乌药;采用HPLC法测定制剂中新橙皮苷、橙皮苷、柚皮苷及去甲异波尔定的含量。结果:四磨汤口服液中枳壳和木香的TLC图谱斑点清晰、重复性好、专属性强、分离较好、方法简便。制剂中新橙皮苷、橙皮苷、柚皮苷及去甲异波尔定分离度良好,阴性样品无干扰。四种成分线性范围分别为0.2525~1.5149μg、0.1824~1.0944μg、0.2524~1.5146μg、0.0263~0.1578μg,平均加样回收率分别为101.54%、101.61%、99.90%和103.44%,RSD值分别为2.56%、2.45%、1.88%和1.24%。4个指标成分测定的精密度、重复性、稳定性和准确度实验RSD值均低于3.00%。结论:该方法简便、快捷,结果准确、可靠,可作为该制剂的质量控制标准。

Objective:To establish the methods of TLC identification and determine contents of four chemical components:Hesperidin,Neohesperidin,Naringin,Norisoboldine for Simotang Oral Liquid,so as to provide basis for quality control of Simotang Oral Liquid.Methods:Citrus aurantium L.,Aucklandia lappa Decne.and Lindera aggregata(Sims)Kos-term.were identified by TLC;The contents of Hesperidin,Neohesperidin,Naringin and Norisoboldine were determined by HPLC.Results:The TLC spots were clear and in good repeatability and without any interference of negative samples.Neohesperidin showed a good linear relationship in the range of 0.2525~1.5149μg with an average recovery of 101.54%(RSD was 2.56%).Hesperidin showed a good linear relationship in the range of0.1824~1.0944μg with an average recovery of 101.61%(RSD was 2.45%).Naringin showed a good linear relationship in the range of 0.2524~1.5146μg with an average recovery of 99.90%(RSD was1.88%).Norisoboldine showed a good linear relationship in the range of 0.0263~0.1578μg with an average recovery of 103.44%(RSD was 1.24%).The RSDs of precision,reproducibility,stability and accuracy all less than 3.00%.Conclusion:The methods are easy,fast and reliable,and could be quality of Simotang Oral Liquid.