【摘要】 目的 建立宣肺达郁颗粒的质量标准。方法 采用薄层色谱（TLC）法对制剂中陈皮、白芍、百合、干姜进行定性鉴别；采用高效液相色谱（HPLC）法同时测定制剂中苦杏仁苷、芍药苷、甘草苷、桂皮醛、橙皮苷的含量，色谱柱为Agilent 5 TC-C₁₈柱（150 mm×4.6 mm,5μm），流动相为甲醇-0.2%乙酸水溶液（梯度洗脱），流速为1.0 mL/min，检测波长为220 nm，柱温为30℃，进样量为15μL。结果 陈皮、白芍、百合、干姜的TLC图斑点清晰，分离度好，且阴性对照无干扰。苦杏仁苷、芍药苷、甘草苷、桂皮醛、橙皮苷质量浓度分别在1.064 0～19.152 0μg/mL、0.820 0～14.760 0μg/mL、0.138 0～2.484 0μg/mL、0.000 5～0.009 0μg/mL、0.432 0～7.776 0μg/mL范围内与峰面积线性关系良好（R²≥0.999 2）；精密度、稳定性、重复性试验结果的RSD均小于3.0%；平均加样回收率分别为97.26%,102.46%,95.63%,98.61%,97.73%;RSD分别为1.69%,3.56%,2.19%,2.64%,0.99%（n=6）。结论 该研究中所建立的标准操作简便，专属性强，结果准确可靠，可用于宣肺达郁颗粒的质量控制。更多还原

【Abstract】 ObjectiveTo establish the quality standard of Xuanfei Dayu Granules.MethodsCitri Reticulatae Pericarpium,PaeoniaeRadix Alba,Lilii Bulbus,Zingiberis Rhizoma in the preparation were identified qualitatively by the thin-layer chromatography（TLC） method,the contents of amygdalin,paeoniflorin,liquiritin,cinnamaldehyde and hesperidin in the preparation were determinedsimultaneously by the high-performance liquid chromatography（HPLC）method. The chromatographic column was Agilent 5 TC-C₁₈ column（150 mm × 4. 6 mm,5 μm）,the mobile phase was methanol-0. 2% acetic acid aqueous solution（gradient elution）,theflow rate was 1. 0 m L/min,the detection wavelength was 220 nm,the column temperature was 30 ℃,and the injection volumewas 15 μL.ResultsThe TLC chromatograms of Citri Reticulatae Pericarpium,Paeoniae Radix Alba,Lilii Bulbus and ZingiberisRhizoma showed clear spots,good resolution,and there was no interference from the negative reference. The linear ranges ofamygdalin,paeoniflorin,liquiritin,cinnamaldehyde and hesperidin were 1. 064 0-19. 152 0 μg/m L,0. 820 0-14. 760 0 μg/m L,0. 138 0-2. 484 0 μg/m L,0. 000 5-0. 009 0 μg/m L,0. 432 0-7. 776 0 μg/m L（R²≥ 0. 999 2） respectively. The RSDsof precision,stability and repeatability tests were all lower than 3. 0%. The average recovery rates of the above five componentswere 97. 26%,102. 46%,95. 63%,98. 61%,97. 73% with RSDs of 1. 69%,3. 56%,2. 19%,2. 64%,0. 99%（n = 6）,respectively.ConclusionThe established standard is simple,specific,accurate and reliable,which can be used for the quality control of XuanfeiDayu Granules.更多还原