疏乳消结颗粒的质量标准研究  

Study on Quality Standard of Shuru Xiaojie Granules

作　　者：刘玉婷 赵丽娟 张伟[2] 郭亮 贾忠[1,2] 潘新波 

机构地区：[1]甘肃农业大学动物医学院,甘肃 兰州 [2]兰州市第二人民医院,甘肃 兰州

出　　处：《中医学》2023年第2期371-379,共9页Traditional Chinese Medicine

摘　　要：目的:建立疏乳消结颗粒的质量标准研究。方法:利用薄层色谱法对疏乳消结颗粒中的柴胡、延胡索、郁金进行定性鉴别;采用高效液相色谱(HPLC)法测定颗粒中没食子酸、芍药苷、柚皮苷和新橙皮苷的含量。色谱柱:Luna C18 (250 ×4.6 mm, 5 μm);流动相:乙腈−0.1%磷酸水,梯度洗脱;检测波长:230 nm;柱温:25℃;进样量:5 μL。结果:柴胡、延胡索及郁金薄层色谱鉴别分离度好,专属性强,阴性对照无干扰。没食子酸质量在0.0065~0.026 μg内线性关系良好,线性方程为Y = 27036X + 10.396,r = 0.9993,平均回收率为99.34%,RSD = 1.61%;芍药苷质量在0.02142~0.08568 μg内线性关系良好,线性方程为Y = 20515X + 25.49,r = 0.9991,平均回收率为102.68%,RSD = 1.92%;柚皮苷质量在0.00402~0.01608 μg内线性关系良好,线性方程为Y= 41493X + 20.324,r = 0.9990,平均回收率为99.1%,RSD = 1.33%;新橙皮苷质量在0.00402~0.01608 μg内线性关系良好,线性方程为Y = 50035X + 18.236,r = 0.9995,平均回收率为100.16%,RSD = 1.43%。结论:该方法简单,重复性好,可以用于疏乳消结颗粒的质量控制。Objective: To establish the quality standard of Shuru Xiaojie Granules. Methods: Thin layer chromatography was used to identify Radix Bupleuri, Rhizoma Corydalis and Radix Curcumae in Shuru Xiaojie Granules. The contents of gallic acid, paeoniflorin, naringin and neohesperidin in granules were determined by high performance liquid chromatography. Chromatographic column: Luna C18 (250 ×4.6 mm, 5 μm);mobile phase: acetonitrile −0.1% phosphoric acid water, gradient elution;detection wavelength: 230 nm;column temperature: 25˚C;injection volume: 5 μL. Results: Radix Bupleuri, Rhizoma Corydalis, Radix Curcumae TLC identification separation degree was good, strong specificity, negative control without interference. The linear range of gallic acid was 0.0065~0.026 μg, the linear equation was Y = 27036X + 10.396, r = 0.9993, the average recovery was 99.34%, RSD = 1.61. The linear range of paeoniflorin was 0.02142~0.08568 μg, the linear equation was Y = 20515X + 25.49, r = 0.9991, the average recovery was 102.68%, RSD = 1.92 %. The linear range of naringin was 0.00402~0.01608 μg, the linear equation was Y = 41493X + 20.324, r = 0.9990, the average recovery was 99.1%, RSD = 1.33%. The linear range of neohesperidin was 0.00402~0.01608 μg, the linear equation was Y= 50035X + 18.236, r = 0.9995, the average recovery was 100.16%, RSD = 1.43%. Conclusions: The method was simple, reproducible and can be used for the quality control of Shuru Xiaojie Granules.

关 键 词：疏乳消结颗粒 高效液相色谱 质量标准 

分 类 号：R28[医药卫生—中药学]