| 引用本文: | 潘琳,高洁,毕若红,韩云凤,石懿,唐茜,张金魁,切尼项毛,赖先荣.十五味赛尔斗丸的质量标准研究[J].中国现代应用药学,2021,38(20):2524-2529. |
| PAN Lin,GAO Jie,BI Ruohong,HAN Yunfeng,SHI Yi,TANG Xi,ZHANG Jinkui,QIENI Xiangmao,LAI Xianrong.Study on Quality Standard of Shiwuwei Sai'erdou Pill[J].Chin J Mod Appl Pharm(中国现代应用药学),2021,38(20):2524-2529. |
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| 十五味赛尔斗丸的质量标准研究 |
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潘琳1, 高洁1, 毕若红1, 韩云凤1, 石懿1, 唐茜1, 张金魁2, 切尼项毛2, 赖先荣1
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1.成都中医药大学, 成都 611137;2.青海久美藏药药业有限公司, 西宁 810000
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| 摘要: |
| 目的 建立十五味赛尔斗丸定性定量检测方法，为其质量标准提高提供依据。方法 采用薄层色谱法，对制剂中诃子、小檗皮、风毛菊进行定性鉴别。通过HPLC同时测定没食子酸、木兰花碱、芒果苷、鞣花酸、盐酸小檗碱的含量。结果 TLC鉴别方法专属性好，斑点清晰且分离度好，阴性对照无干扰；含量测定结果显示，没食子酸在0.054 64~0.437 12 μg，木兰花碱在0.090 12~0.720 96 μg，芒果苷在0.012 64~0.102 72μg，鞣花酸0.040 56~0.324 48μg，盐酸小檗碱在0.034 68~0.277 44μg，线性关系良好。仪器精密度、重复性、稳定性、加样回收率的RSD值均符合要求。结论 所建立的方法操作简单，重复性较好，可用于十五味赛尔斗丸的质量控制研究。 |
| 关键词: 十五味赛尔斗丸 质量标准 薄层色谱 含量测定 |
| DOI：10.13748/j.cnki.issn1007-7693.2021.20.008 |
| 分类号:R284.1 |
| 基金项目:国家重点研发计划项目（2017YFC1703904）；四川省科技厅区域创新合作项目（2020YFQ0032）；青海省科技厅重点研发与转化专项（2020-SF-C33） |
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| Study on Quality Standard of Shiwuwei Sai'erdou Pill |
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PAN Lin1, GAO Jie1, BI Ruohong1, HAN Yunfeng1, SHI Yi1, TANG Xi1, ZHANG Jinkui2, QIENI Xiangmao2, LAI Xianrong1
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1.Chengdu University of Traditional Chinese Medicine, Chengdu 611137, China;2.Qinghai Jiumei Tibetan Medicine Co., Ltd., Xining 810000, China
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| Abstract: |
| OBJECTIVE To establish a method for the qualitative and quantitative determination of Shiwuwei Sai'erdou pill, and to provide the basis for the improvement of its quality standard. METHODS TLC was used to identify Chebulae Fructus, Berberis Bark and Chrysanthemum Morifolium. The contents of gallic acid, magnolia alkaloid, mangiferin, ellagic acid and berberine hydrochloride were determined by HPLC. RESULTS TLC identification method had good specificity, clear spots and good resolution, negative control had no interference. The content determination results showed the linear relationship was good within 0.054 64-0.437 12 μg of gallic acid, 0.090 12-0.720 96 μg of magnolia alkaloid, 0.012 64-0.102 72 μg of mangiferin, 0.040 56-0.324 48 μg of ellagic acid, 0.034 68-0.277 44 μg of berberine hydrochloride. The RSD of instrument precision, repeatability, stability and recovery all met the requirements. CONCLUSION The method is simple and reproducible, and can be used for the quality control of Shiwuwei Sai'erdou pill. |
| Key words: Shiwuwei Sai'erdou pill quality standard TLC content determination |
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