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乳癖平颗粒质量标准研究

Quality Standard of Rupiping Granules
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摘要 目的建立乳癖平颗粒的质量标准。方法采用薄层色谱(TLC)法对乳癖平颗粒中鸡血藤、山楂进行定性鉴别。采用反相高效液相色谱(RP-HPLC)法对乳癖平颗粒中的表儿茶素进行含量测定,色谱柱为Diamonsil C18柱(200 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸溶液(11∶89,V/V),流速为1.0 mL/min,检测波长为280 nm,柱温为30℃,进样量为20μL。结果鸡血藤、山楂的TLC特征斑点清晰,阴性对照无干扰;表儿茶素质量浓度在8.216~41.080μg/mL范围内与峰面积线性关系良好(r=0.999 9),平均加样回收率为102.50%,RSD为1.91%(n=6)。结论该方法操作简单、快速、准确,可用于乳癖平颗粒的质量控制。 Objective To establish the quality standard of Rupiping Granules.Methods Thin layer chromatography( TLC) method was employed to identify Caulis spatholobi,Fructus crataegi,and the content of epicatechin in Rupiping Granules was determined by reversed phase-high performance liquid chromatography( RP-HPLC).The chromatographic column was Diamonsil C18 column( 200 mm × 4.6 mm,5 μm),the mobile phase was acetonitrile-0.1% phosphoric acid( 11 ∶ 89,V/V),the flow rate was 1.0 mL/min,the detection wavelength was 280 nm,the column temperature was 30 ℃,and the injection volume was 20 μL.Results The characteristic spots of Caulis spatholobi,Fructus crataegi clearly appeared in the TLC,and there was no interference for the negative sample.The chromatographic peaks of epicatechin were well separated from other chromatographic peaks.The linear relationship between the concentration of epicatechin and the peak area was good in the range of 8.216-41.080 μg/mL( r = 0.999 9).The average recovery of epicatechin was 102.50%,RSD = 1.91%( n = 6).Conclusion The established method is simple,rapid,and accurate,which can be used for quality control of Rupiping Granules.
作者 胡斌 胡婧 邓莉 马攀 HU Bin;HU Jing;DENG Li;MA Pan(Depurtment of Pharmacy,The First Hospital Affiliated to Army Medical Unitersity,Chongging,China 400038)
出处 《中国药业》 CAS 2020年第19期57-60,共4页 China Pharmaceuticals
关键词 乳癖平颗粒 表儿茶素 山楂 鸡血藤 薄层色谱法 高效液相色谱法 质量标准 Rupiping Granules epicatechin Fructus crataegi Caulis spatholobi thin layer chromatography high performance liquid chromatography quality standard
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