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陈皮配方颗粒的质量标准提高研究
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| 篇名： | 陈皮配方颗粒的质量标准提高研究 |
| TITLE： | |
| 摘要： | 目的：完善和提高陈皮配方颗粒的质量标准。方法：以4个不同厂家的13批陈皮配方颗粒为试验样品，按2015年版《中国药典》（四部）薄层色谱法（TLC）对样品中橙皮苷和川陈皮素进行定性鉴别；采用超高效液相色谱法（UPLC）对样品中柚皮苷、橙皮苷、橙皮素、川陈皮素和桔皮素进行定量分析[色谱柱为Waters Acquity UPLC BEH C18；流动相为乙腈-0.2％磷酸水溶液，梯度洗脱；检测波长为283 nm；进样量为3 μL]。结果：TLC结果显示，在供试品色谱中，与对照品色谱相应位置上均显相同颜色的斑点。UPLC结果显示，柚皮苷、橙皮苷、橙皮素、川陈皮素和桔皮素检测质量浓度的线性范围分别为0.64～6.44、15.78～157.80、0.17～1.66、2.08～20.85和2.04～20.43 μg/mL（r均≥0.999 2），检测限分别为0.03、0.33、0.10、0.20和0.06 μg/mL，定量限分别为0.07、1.34、0.20、0.60和0.22 μg/mL，平均加样回收率分别为99.4％、99.6％、99.7％、99.7％和99.7％（n＝9），精密度（n＝6）、稳定性（n＝7）、重复性（n＝6）试验的RSD均≤2.03％。仅在1个厂家的3批样品中检测出了柚皮苷（含量范围为0.067 3～0.069 6 mg/g），而其余4个成分在13批样品中均有检测到，含量范围分别为0.646 5～1.728 0、0.102 6～0.290 5、0.023 1～0.689 8、0.018 2～0.270 7 mg/g。结论：本研究通过定性、定量方法完善了陈皮配方颗粒的质量标准，并初步限定了其中橙皮苷、橙皮素、川陈皮素和桔皮素的含量分别不低于0.60、0.10、0.02和0.01 mg/g。 |
| ABSTRACT： | OBJECTIVE： To optimize and improve the quality standard for Citrus reticulata formula granules. METHODS： Totally 13 batches of C. Reticulata formula granules from 4 different manufacturers were used as trial samples， and qualitative identification of hesperidin and nobiletin in the samples were carried out by TLC according to the method of 2015 edition of Chinese Pharmacopoeia （part Ⅳ）. The quantitative analysis of naringin， hesperidin， hesperetin， nobiletin and tangeretin in C. reticulatae formula granules were conducted by UPLC[The determination was performed on Waters Acquity UPLC BEH C18 column with mobile phase consisted of acetonitrile-0.2％ phosphoric acid aqueous solution （gradient elution）. The detection wavelength was set at 283 nm， and sample size was 3 μL]. RESULTS： The results of TLC showed that in the chromatograms of samples， same color spots were shown in the corresponding positions of the chromatogram of reference substance. The results of UPLC showed， that the linear range of naringin， hesperidin， hesperetin， nobiletin and tangeretin were 0.64-6.44， 15.78-157.80， 0.17-1.66， 2.08-20.85 and 2.04-20.43 μg/mL， respectively （all r≥0.999 2）； the limits of detection were 0.03， 0.33， 0.10， 0.20 and 0.06 μg/mL； the limits of quantitation were 0.07， 1.34， 0.20， 0.60 and 0.22 μg/mL. The average recoveries were 99.4％， 99.6％， 99.7％， 99.7％ and 99.7％ （n＝9）； RSDs of precision （n＝6）， stability （n＝7） and reproducibility （n＝6） tests were all≤2.03％； naringin was detected in only 3 batches of samples from one manufacturer （the content ranged from 0.067 3 to 0.069.6 mg/g）， while the other 4 components were detected in 13 batches of samples （the contents of them ranged 0.646 5-1.728 0， 0.102 6-0.290 5， 0.023 1-0.689 8， 0.018 2-0.270 7 mg/g）. CONCLUSIONS： In this study， the quality standard of C. reticulata formula granules was improved by qualitative and quantitative methods， and the contents of hesperidin， hesperetin， nobiletin and tangeretin were not less than 0.60， 0.10， 0.02 and 0.01 mg/g， respectively. |
| 期刊： | 2019年第30卷第7期 |
| 作者： | 黄华花，张伟云，陈景海，吕诗诗，王圣江 |
| AUTHORS： | HUANG Huahua，ZHANG Weiyun，CHEN Jinghai，LYU Shishi，WANG Shengjiang |
| 关键字： | 陈皮配方颗粒；质量标准；薄层色谱；超高效液相色谱法 |
| KEYWORDS： | Citrus reticulata formula granules； Quality standard； TLC； UPLC |
| 阅读数： | 695 次 |
| 本月下载数： | 6 次 |
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