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目的确定正天丸含量测定结果的影响因素。方法对含量不合格样品,按照正天丸质量标准含量测定方法,采用不同洗脱速度、不同用量、不同批号的柱层析用氧化铝,对样品及芍药苷对照品进行处理并测定。结果氧化铝的批号不同,是芍药苷含量不合格的主要影响因素。结论采用氧化铝柱层析时,芍药苷含量测定结果的判定要考虑氧化铝的影响,才能得出正确的判定结论。
Objective To determine the influential factors of Zhengtian Pills content determination results. Methods Samples with unqualified content and the standard of paeoniflorin were treated and determined according to the method of content determination of Zhengtian Pills by using different elution rates, different dosage and different batch numbers by column chromatography with alumina. As a result, the batch numbers of alumina were different and were the main influencing factors for the unqualified paeoniflorin. Conclusion When using alumina column chromatography, the determination of the results of determination of paeoniflorin should consider the impact of alumina in order to arrive at the correct conclusion.