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扭伤归胶囊的质量标准提升
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| 篇名： | 扭伤归胶囊的质量标准提升 |
| TITLE： | Study on the improvement of quality standard for Niushanggui capsules |
| 摘要： | 目的 为提高扭伤归胶囊的质量标准提供参考。方法在现行质量标准的基础上，建立扭伤归胶囊中白芷和知母的薄层色谱（TLC）鉴别方法，建立同时测定芒果苷、升麻素苷、柚皮苷、新橙皮苷和5-O-甲基维斯阿米醇苷5种成分含量的高效液相色谱（HPLC）法并确定限度。结果扭伤归胶囊供试品TLC图中，在与相应（混合）对照品或白芷、知母对照药材相同位置上，均显相同颜色的斑点，且阴性对照无干扰。芒果苷、升麻素苷、柚皮苷、新橙皮苷和5-O-甲基维斯阿米醇苷检测质量浓度的线性范围分别为7.98～127.63、6.74～107.84、53.06～848.96、39.31～628.90、13.54～216.62μg/mL（r均为0.9999）；精密度、稳定性（24h）、重复性试验的RSD均不高于1.20％（n＝6），平均加样回收率分别为95.00％、105.16％、97.16％、101.00％、104.97％（RSD≤1.50％，n＝6）。4批样品中，上述5种成分的平均含量分别为0.842、0.696、6.951、5.755、1.106mg/g，方中知母、防风、枳壳分别以芒果苷含量、升麻素苷和5-O-甲基维斯阿米醇苷总量、柚皮苷和新橙皮苷总量计不得少于0.42、0.90、6.36mg/粒。结论本研究建立了扭伤归胶囊中白芷、知母的TLC鉴别方法及芒果苷等5种成分的含量测定方法，并确定了方中知母、防风、枳壳的限度。 |
| ABSTRACT： | OBJECT IVE To provide reference for the improvement of the quality standard for Niushanggui capsules. METHODS Based on the previous quality standard ，thin-layer chromatography （TLC）identification methods were established for Angelicae dahurica and Anemarrhenae asphodeloides . High performance liquid chromatography （HPLC）method was established to determine the contents of 5 components simultaneously ，such as mangiferin ，prim-O-glucosylcimifugin，naringin，neohesperidin and 5-O-methylvisammioside. The limits were confirmed. RESULTS TLC chromatogram of Niushanggui capsules showed the same color spots in the same position as the corresponding （mixed）substance control or reference medicinal material of A. dahuricae and A. asphodeloides ，while the negative samples had no interference. The linear range of mangiferin ，prim-O-glucosylcimifugin， naringin，neohesperidin and 5-O-methylvisammioside were 7.98-127.63，6.74-107.84，53.06-848.96，39.31-628.90，13.54-216.62 μg/mL，respectively（all r＝0.999 9）. RSDs of precision ，stability（24 h）and repeatability tests were all no more than 1.20％（n＝ 6）. The average recoveries were 95.00％，105.16％，97.16％，101.00％ and 104.97％（RSD≤1.50％，n＝6）. In 4 batches of samples，the average contents of the above 5 components were 0.842，0.696，6.951，5.755 and 1.106 mg/g respectively ；the limits of A. asphodeloides ，Saposhnikovia divaricata and Citrus aurantium were based on the contents of mangiferin ，the total content of prim-O-glucosylcimmifugin and 5-O-methylvisammioside，naringin and neohesperidin ，which would not be less than 0.42，0.90 and 6.36 mg/grain，respectively. CONCLUSIONS TLC identification methods of A. dahurica and A. asphodeloides and the content determination methods of 5 components as mangiferin in Niushanggui capsules are established in this study ，and the limits of A. asphodeloides ，S. divaricata and C. aurantium are confirmed. |
| 期刊： | 2022年第33卷第06期 |
| 作者： | 黄萍，冯有龙，周娟娟，时佩，史清水 |
| AUTHORS： | HUANG Ping，FENG Youlong ，ZHOU Juanjuan ，SHI Pei，SHI Qingshui |
| 关键字： | 扭伤归胶囊；鉴别；含量测定；质量标准提升 |
| KEYWORDS： | Niushanggui c apsules；identification；content determination ；improvement of quality standard |
| 阅读数： | 278 次 |
| 本月下载数： | 3 次 |
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