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目的:建立以柚皮苷为内参物,同时测定胃苏颗粒中芸香柚皮苷、柚皮苷、橙皮苷、新橙皮苷的一测多评HPLC法,并进行方法学考察。方法:以胃苏颗粒为研究对象,以柚皮苷为内参物,确定其他3种成分相对于柚皮苷的校正因子,通过相对校正因子(RCF)对芸香柚皮苷、橙皮苷、新橙皮苷进行定量,实现一测多评(计算法);同时采用外标法测定胃苏颗粒中4种成分的含量(实测法),并比较一测多评法与外标法测定结果的差异。结果:在一定的线性范围内,柚皮苷与芸香柚皮苷、橙皮苷、新橙皮苷的相对校正因子分别为1.146、1.018、0.987;且在不同实验条件下重现性良好(RSD分别为1.5%、1.8%、2.7%);37批胃苏颗粒中4种成分按一测多评方法与外标法测定结果基本一致(RSD<2%)。结论:本文建立的一测多评方法操作简单,测定结果准确。在对照品缺乏的情况下,可作为一个新模式用于胃苏颗粒的多成分定量,并为全面控制胃舒颗粒的质量提供参考。
OBJECTIVE: To establish a method for the determination of naringin, naringin, hesperidin and neohesperidin in Weisu granules with naringin as an internal reference substance and to evaluate the method by HPLC. Methods: We took Weiweisi Granules as research object and naringin as internal reference to determine the calibration factors of other three components relative to naringin. Rutin, hesperidin and hesperidin were determined by relative correction factor (RCF) Hesperidin was quantified to achieve a test for multiple assessment (calculation method); while the external standard method for the determination of the content of the four components of Wei Su particles (measured method), and compared a test to determine the results of the method and the external standard difference. Results: The relative calibration factors of naringin and rutin naringin, hesperidin and neohesperidin were 1.146, 1.018 and 0.987 in a certain linear range, respectively, and were reproducible under different experimental conditions (RSD Respectively 1.5%, 1.8%, 2.7%); 37 batches of Wei Su particles four components according to a multi-evaluation method and the external standard determination of the results are basically the same (RSD <2%). Conclusion: This paper established a test multiple evaluation method is simple, accurate measurement results. In the absence of reference substance, it can be used as a new model for multi-component quantitation of Wei-Su particles and provide a reference for the comprehensive control of Wei Shu particles.