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目的:建立知柏地黄泡腾颗粒的质量标准。方法:采用TLC方法对知柏地黄泡腾颗粒中牡丹皮、山茱萸、黄柏进行定性鉴别;采用HPLC法测定了马钱苷和丹皮酚的含量,色谱柱为Hypersil C18柱(250mm×4.6 mm,5μm),马钱苷的流动相为乙腈-水(14∶86),流速为1.0 mL.min-1,检测波长为240 nm。丹皮酚的流动相为甲醇-0.1%磷酸溶液(47∶53),流速为1.0 mL.min-1,检测波长为274 nm。结果:TLC法可检出牡丹皮、山茱萸、黄柏,斑点清晰,阴性对照无干扰,专属性强。马钱苷的平均加样回收率为99.14%,RSD为0.87%。线性范围为0.181 2~1.359 0μg(r=0.999 9)。丹皮酚的平均加样回收率为101.21%,RSD为2.00%。线性范围为0.099~0.495μg(r=0.999 6)。结论:本方法准确可靠,可作为知柏地黄泡腾颗粒的质量控制方法。
Objective: To establish the quality standard of Zhibaihuanghuang effervescent granules. METHODS: The contents of loganin and paeonol in Zhibelhuanghuang effervescent granules were identified by TLC. The chromatographic column was Hypersil C18 column (250 mm × 4.6 mm, 5 μm). The mobile phase of loganin was acetonitrile-water (14:86) with a flow rate of 1.0 mL · min-1 and a detection wavelength of 240 nm. Paeonol mobile phase methanol -0.1% phosphoric acid solution (47:53), the flow rate of 1.0 mL.min-1, the detection wavelength was 274 nm. Results: TLC method can be found in tree peony bark, dogwood, cork, spots clear, negative control without interference, specificity. The average recovery of loganin was 99.14% with a RSD of 0.87%. The linear range was 0.181 2 ~ 1.359 0 μg (r = 0.999 9). The average recoveries of paeonol were 101.21% and RSD was 2.00%. The linear range was 0.099-0.495 μg (r = 0.999 6). Conclusion: The method is accurate and reliable and can be used as quality control method for Zhibelhuanghuang effervescent granules.