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目的:建立HPLC法测定玳玳黄酮滴丸中有效成分含量的不确定度评定分析方法,探讨合成标准中影响含量测定不确定度贡献较大的分量。方法:采用HPLC含量测定法建立数学模型,分析含量测定的不确定度来源,参考不确定度相关评定规定进行合成标准不确定度及扩展不确定度的评定。结果:玳玳黄酮滴丸柚皮苷与新橙皮苷HPLC含量测定不确定度的主要影响因素由对照品及供试品溶液的浓度引入,不确定度报告结果分别为柚皮苷(55.52±1.22)mg·g-1、新橙皮苷(66.87±1.48)mg·g-1。结论:建立的含量测定的不确定度评定法有助于控制测定结果更准确、可靠,对中药质量标准制定具有指导意义。
Objective: To establish an HPLC method for the determination of the content of active ingredients in tortoise shell flavonoids dropping pills assessment of uncertainty, and to explore the composition of the standard uncertainty contribution to the determination of the larger components. Methods: A mathematical model was established by HPLC method. The sources of the uncertainty of the determination were analyzed. The uncertainty of the synthesis standard and the uncertainty of the expansion were evaluated with reference to the relevant assessment rules of uncertainty. Results: The main influencing factors of the determination of the content of naringin and neohesperidin of Toibeimei Flavone Dripping Pill were introduced from the concentration of the reference substance and the test solution. The results of the uncertainty report were naringin (55.52 ± 1.22) mg · g-1, neohesperidin (66.87 ± 1.48) mg · g-1. Conclusion: The established method for the determination of the uncertainty of the content determination can help to control the determination results more accurately and reliably, and is of guiding significance for the formulation of the quality standard of Chinese medicine.